DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 1

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** 3 **

3D IMAGING DRUG

* 3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

3M

* 3M CO

PERIDEX, CHLORHEXIDINE GLUCONATE

* 3M HEALTH CARE INC

AVAGARD, ALCOHOL (OTC)

DURAPREP, IODINE POVACRYLEX (OTC)

3M HEALTH CARE

* 3M HEALTH CARE INFECTION PREVENTION DIV

SOLUPREP S, CHLORHEXIDINE GLUCONATE (OTC)

** 6 **

60 DEGREES PHARMS

* 60 DEGREES PHARMACEUTICALS INC

ARAKODA, TAFENOQUINE SUCCINATE

** A **

AAA USA INC

* ADVANCED ACCELERATOR APPLICATIONS USA INC

LUTATHERA, LUTETIUM LU 177 DOTATATE

NETSPOT, GALLIUM DOTATATE GA-68

AADI

* AADI BIOSCIENCE INC

FYARRO, SIROLIMUS

AAIPHARMA LLC

* AAIPHARMA LLC

AZASAN, AZATHIOPRINE

ABBVIE

* ABBVIE

OXYTROL FOR WOMEN, OXYBUTYNIN (OTC)

* ABBVIE INC

ACULAR LS, KETOROLAC TROMETHAMINE

ACULAR, KETOROLAC TROMETHAMINE

ACUVAIL, KETOROLAC TROMETHAMINE

ACZONE, DAPSONE

ALPHAGAN P, BRIMONIDINE TARTRATE

BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE

BENTYL, DICYCLOMINE HYDROCHLORIDE

CANASA, MESALAMINE

CARAFATE, SUCRALFATE

CELEXA, CITALOPRAM HYDROBROMIDE

COMBIGAN, BRIMONIDINE TARTRATE

CYCLOSPORINE, CYCLOSPORINE

DALVANCE, DALBAVANCIN HYDROCHLORIDE

DELZICOL, MESALAMINE

DEPAKOTE ER, DIVALPROEX SODIUM

DEPAKOTE, DIVALPROEX SODIUM

DUOPA, CARBIDOPA

DURYSTA, BIMATOPROST

FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE

FML FORTE, FLUOROMETHOLONE

FML, FLUOROMETHOLONE

GENGRAF, CYCLOSPORINE

KALETRA, LOPINAVIR

LASTACAFT, ALCAFTADINE (OTC)

LATISSE, BIMATOPROST

LEXAPRO, ESCITALOPRAM OXALATE

LINZESS, LINACLOTIDE

LUMIGAN, BIMATOPROST

MAVYRET, GLECAPREVIR

NAMENDA XR, MEMANTINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 2

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ABBVIE INC

NAMENDA, MEMANTINE HYDROCHLORIDE

NAMZARIC, DONEPEZIL HYDROCHLORIDE

NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE

NIMBEX, CISATRACURIUM BESYLATE

NORVIR, RITONAVIR

ORIAHNN (COPACKAGED), ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE

ORILISSA, ELAGOLIX SODIUM

OZURDEX, DEXAMETHASONE

PRED FORTE, PREDNISOLONE ACETATE

PRED MILD, PREDNISOLONE ACETATE

QULIPTA, ATOGEPANT

RECTIV, NITROGLYCERIN

RESTASIS MULTIDOSE, CYCLOSPORINE

RESTASIS, CYCLOSPORINE

RINVOQ, UPADACITINIB

SAVELLA, MILNACIPRAN HYDROCHLORIDE

SYNTHROID, LEVOTHYROXINE SODIUM **

TEFLARO, CEFTAROLINE FOSAMIL

TRICOR, FENOFIBRATE

TRILIPIX, CHOLINE FENOFIBRATE

UBRELVY, UBROGEPANT

ULTANE, SEVOFLURANE

VENCLEXTA, VENETOCLAX

VIBERZI, ELUXADOLINE

VIIBRYD, VILAZODONE HYDROCHLORIDE

VRAYLAR, CARIPRAZINE HYDROCHLORIDE

VUITY, PILOCARPINE HYDROCHLORIDE

ZEMPLAR, PARICALCITOL

ZYMAXID, GATIFLOXACIN

ABBVIE ENDOCRINE INC

* ABBVIE ENDOCRINE INC

LUPRON DEPOT, LEUPROLIDE ACETATE

LUPRON DEPOT-PED KIT, LEUPROLIDE ACETATE

ABHAI INC

* ABHAI INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

ABHAI LLC

* ABHAI LLC

ATOVAQUONE, ATOVAQUONE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

LEFLUNOMIDE, LEFLUNOMIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

URSODIOL, URSODIOL

ABON PHARMS LLC

* ABON PHARMACEUTICALS LLC

ATOVAQUONE, ATOVAQUONE

CLOFARABINE, CLOFARABINE

ABRAXIS PHARM

* ABRAXIS PHARMACEUTICAL PRODUCTS

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

ACACIA

* ACACIA PHARMA LTD

BARHEMSYS, AMISULPRIDE

BYFAVO, REMIMAZOLAM BESYLATE

ACADIA PHARMS INC

* ACADIA PHARMACEUTICALS INC

DAYBUE, TROFINETIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 3

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACADIA PHARMACEUTICALS INC

NUPLAZID, PIMAVANSERIN TARTRATE

ACCELRX LABS

* ACCELRX LABS LLC

CARISOPRODOL, CARISOPRODOL

ACCORD

* ACCORD BIOPHARMA INC

CAMCEVI KIT, LEUPROLIDE MESYLATE

ACCORD HLTHCARE

* ACCORD HEALTHCARE INC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALLOPURINOL, ALLOPURINOL

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

APIXABAN, APIXABAN

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATROPINE SULFATE, ATROPINE SULFATE

AZACITIDINE, AZACITIDINE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BIVALIRUDIN, BIVALIRUDIN

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CABAZITAXEL, CABAZITAXEL

CAPECITABINE, CAPECITABINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBOPLATIN, CARBOPLATIN

CARMUSTINE, CARMUSTINE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CISPLATIN, CISPLATIN

CLOFARABINE, CLOFARABINE

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOZAPINE, CLOZAPINE

DALFAMPRIDINE, DALFAMPRIDINE

DAPTOMYCIN, DAPTOMYCIN

DECITABINE, DECITABINE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DOCETAXEL, DOCETAXEL

DODEX, CYANOCOBALAMIN

DOFETILIDE, DOFETILIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

EPLERENONE, EPLERENONE

EPTIFIBATIDE, EPTIFIBATIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ETOPOSIDE, ETOPOSIDE

EZETIMIBE, EZETIMIBE

FINASTERIDE, FINASTERIDE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUOROURACIL, FLUOROURACIL

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FULVESTRANT, FULVESTRANT

FUROSEMIDE, FUROSEMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLIPIZIDE, GLIPIZIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 4

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACCORD HEALTHCARE INC

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

LETROZOLE, LETROZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LISINOPRIL, LISINOPRIL

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MITOMYCIN, MITOMYCIN

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PACLITAXEL, PACLITAXEL

PARICALCITOL, PARICALCITOL

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIRFENIDONE, PIRFENIDONE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROGESTERONE, PROGESTERONE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RAMIPRIL, RAMIPRIL

REGADENOSON, REGADENOSON

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SPIRONOLACTONE, SPIRONOLACTONE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TACROLIMUS, TACROLIMUS

TADALAFIL, TADALAFIL

TEMOZOLOMIDE, TEMOZOLOMIDE

TEMSIROLIMUS, TEMSIROLIMUS

TERIFLUNOMIDE, TERIFLUNOMIDE

TOPIRAMATE, TOPIRAMATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ACCORD HLTHCARE INC

* ACCORD HEALTHCARE INC USA

BUSULFAN, BUSULFAN

TIGECYCLINE, TIGECYCLINE

ACELLA

* ACELLA PHARMACEUTICALS LLC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BENZONATATE, BENZONATATE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CICLOPIROX, CICLOPIROX

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DUTASTERIDE, DUTASTERIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 5

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACELLA PHARMACEUTICALS LLC

NIFEDIPINE, NIFEDIPINE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

ACELLA PHARMS LLC

* ACELLA PHARMACEUTICALS LLC

GABAPENTIN, GABAPENTIN

ACER

* ACER THERAPEUTICS INC

OLPRUVA, SODIUM PHENYLBUTYRATE

ACERUS

* ACERUS PHARMACEUTICALS CORP

NATESTO, TESTOSTERONE

ACI

* ACI HEALTHCARE LTD

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZITHROMYCIN, AZITHROMYCIN

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

LEVETIRACETAM, LEVETIRACETAM

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ACIC PHARMS

* ACIC PHARMACEUTICALS INC

BACLOFEN, BACLOFEN

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

TRANEXAMIC ACID, TRANEXAMIC ACID

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ACORDA

* ACORDA THERAPEUTICS INC

AMPYRA, DALFAMPRIDINE

INBRIJA, LEVODOPA

ACROTECH BIOPHARMA

* ACROTECH BIOPHARMA INC

BELEODAQ, BELINOSTAT

EVOMELA, MELPHALAN HYDROCHLORIDE

FOLOTYN, PRALATREXATE

FUSILEV, LEVOLEUCOVORIN CALCIUM

KHAPZORY, LEVOLEUCOVORIN

ACS DOBFAR

* ACS DOBFAR SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFOXITIN, CEFOXITIN SODIUM

CEFTAZIDIME, CEFTAZIDIME

CEFTRIAXONE, CEFTRIAXONE SODIUM

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

MEROPENEM, MEROPENEM

ACS DOBFAR SPA

* ACS DOBFAR SPA

AMPICILLIN SODIUM, AMPICILLIN SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

ERTAPENEM SODIUM, ERTAPENEM SODIUM

MEROPENEM, MEROPENEM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

ACTAVIS

* ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

DOCETAXEL, DOCETAXEL

HYDROXOCOBALAMIN, HYDROXOCOBALAMIN

OXALIPLATIN, OXALIPLATIN

PEMETREXED, PEMETREXED

ACTAVIS ELIZABETH

* ACTAVIS ELIZABETH LLC

ALBENDAZOLE, ALBENDAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 6

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS ELIZABETH LLC

ALPRAZOLAM, ALPRAZOLAM

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DEFERASIROX, DEFERASIROX

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE, DEXTROMETHORPHAN HYDROBROMIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GABAPENTIN, GABAPENTIN

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

INDAPAMIDE, INDAPAMIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LAMOTRIGINE, LAMOTRIGINE

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LOVASTATIN, LOVASTATIN

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NIFEDIPINE, NIFEDIPINE

OXAZEPAM, OXAZEPAM

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PREGABALIN, PREGABALIN

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

RANOLAZINE, RANOLAZINE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TEMAZEPAM, TEMAZEPAM

* ACTAVIS ELIZABETH LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

ALPRAZOLAM, ALPRAZOLAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

ACTAVIS INC

* ACTAVIS INC

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

ACTAVIS LABS

* ACTAVIS LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

PERMETHRIN, PERMETHRIN

ACTAVIS LABS FL

* ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

ISOTRETINOIN, ISOTRETINOIN

MESALAMINE, MESALAMINE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

ACTAVIS LABS FL INC

* ACTAVIS LABORATORIES FL INC

BUDESONIDE, BUDESONIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 7

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS LABORATORIES FL INC

CARTIA XT, DILTIAZEM HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DALFAMPRIDINE, DALFAMPRIDINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

GEFITINIB, GEFITINIB

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

LEVETIRACETAM, LEVETIRACETAM

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NAPROXEN SODIUM, NAPROXEN SODIUM

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

OMEPRAZOLE, OMEPRAZOLE

PALIPERIDONE, PALIPERIDONE

PAROXETINE MESYLATE, PAROXETINE MESYLATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISONE, PREDNISONE

RAMELTEON, RAMELTEON

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TAZTIA XT, DILTIAZEM HYDROCHLORIDE

TETRABENAZINE, TETRABENAZINE

TRANEXAMIC ACID, TRANEXAMIC ACID

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

ACTAVIS LABS UT INC

* ACTAVIS LABORATORIES UT INC

AZELAIC ACID, AZELAIC ACID

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLONIDINE, CLONIDINE

FIORICET W/ CODEINE, ACETAMINOPHEN

LIDOCAINE, LIDOCAINE

SCOPOLAMINE, SCOPOLAMINE

TESTOSTERONE, TESTOSTERONE

* ACTAVIS LABORATORIES UT INC INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

PIMECROLIMUS, PIMECROLIMUS

TESTOSTERONE, TESTOSTERONE

ACTAVIS LLC

* ACTAVIS LLC

AZACITIDINE, AZACITIDINE

DAPSONE, DAPSONE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

ACTAVIS MID ATLANTIC

* ACTAVIS MID ATLANTIC LLC

ACYCLOVIR, ACYCLOVIR

ADAPALENE, ADAPALENE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 8

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ACTAVIS MID ATLANTIC LLC

HYDROCORTISONE, HYDROCORTISONE

LEVETIRACETAM, LEVETIRACETAM

MESALAMINE, MESALAMINE

NITROFURANTOIN, NITROFURANTOIN

NYSTATIN, NYSTATIN

VALNAC, BETAMETHASONE VALERATE

* ACTAVIS MID ATLANTIC LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

IBUPROFEN, IBUPROFEN

PERMETHRIN, PERMETHRIN (OTC)

ACTAVIS PHARMA

* ACTAVIS PHARMA INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

MICONAZOLE NITRATE, MICONAZOLE NITRATE

ACTAVIS TOTOWA

* ACTAVIS TOTOWA LLC

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

ACTELION

* ACTELION PHARMACEUTICALS US INC

OPSUMIT, MACITENTAN

TRACLEER, BOSENTAN

UPTRAVI, SELEXIPAG

VELETRI, EPOPROSTENOL SODIUM

VENTAVIS, ILOPROST

ZAVESCA, MIGLUSTAT

ADAMAS OPERATIONS

* ADAMAS OPERATIONS LLC

GOCOVRI, AMANTADINE HYDROCHLORIDE

OSMOLEX ER, AMANTADINE HYDROCHLORIDE

ADAMIS PHARMS CORP

* ADAMIS PHARMACEUTICALS CORP

SYMJEPI, EPINEPHRINE

ZIMHI, NALOXONE HYDROCHLORIDE

ADAPTIS

* ADAPTIS PHARMA PRIVATE LTD

BICALUTAMIDE, BICALUTAMIDE

DUTASTERIDE, DUTASTERIDE

PREGABALIN, PREGABALIN

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

ADARE PHARMS INC

* ADARE PHARMACEUTICALS INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

ADHERA

* ADHERA THERAPEUTICS INC

PRESTALIA, AMLODIPINE BESYLATE

ADIENNE SA

* ADIENNE SA

TEPADINA, THIOTEPA

AET PHARMA

* AET PHARMA US INC

LEFLUNOMIDE, LEFLUNOMIDE

POSACONAZOLE, POSACONAZOLE

AFAXYS

* AFAXYS PHARMA LLC

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

AGEPHA PHARMA FZ
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 9

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AGEPHA PHARMA FZ LLC

LODOCO, COLCHICINE

AGILE

* AGILE THERAPEUTICS INC

TWIRLA, ETHINYL ESTRADIOL

AGIOS PHARMS INC

* AGIOS PHARMACEUTICALS INC

PYRUKYND, MITAPIVAT SULFATE

AGNITIO

* AGNITIO INC

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ETHACRYNIC ACID, ETHACRYNIC ACID

PHYTONADIONE, PHYTONADIONE

TRIAMTERENE, TRIAMTERENE

AGOURON PHARMS

* AGOURON PHARMACEUTICALS LLC

VIRACEPT, NELFINAVIR MESYLATE

AILEX PHARMS LLC

* AILEX PHARMACEUTICALS LLC

CROMOLYN SODIUM, CROMOLYN SODIUM

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

AIPING PHARM INC

* AIPING PHARMACEUTICAL INC

LEVETIRACETAM, LEVETIRACETAM

SORINE, SOTALOL HYDROCHLORIDE

AIRGAS THERAP

* AIRGAS THERAPEUTICS LLC

ULSPIRA, NITRIC OXIDE

AIRIS PHARMA PVT LTD

* AIRIS PHARMA PRIVATE LTD

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

AIZANT

* AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LTD

ALBUTEROL SULFATE, ALBUTEROL SULFATE

PIRFENIDONE, PIRFENIDONE

ZILEUTON, ZILEUTON

* AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

ELIGLUSTAT TARTRATE, ELIGLUSTAT TARTRATE

AJANTA PHARMA LTD

* AJANTA PHARMA LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

CAPTOPRIL, CAPTOPRIL

CHLORTHALIDONE, CHLORTHALIDONE

CHOLESTYRAMINE, CHOLESTYRAMINE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DROXIDOPA, DROXIDOPA

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

ENTACAPONE, ENTACAPONE

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 10

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AJANTA PHARMA LTD

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RANOLAZINE, RANOLAZINE

RISPERIDONE, RISPERIDONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

TADALAFIL, TADALAFIL

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TOPIRAMATE, TOPIRAMATE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZOLMITRIPTAN, ZOLMITRIPTAN

AJENAT PHARMS

* AJENAT PHARMACEUTICALS LLC

DESOXYN, METHAMPHETAMINE HYDROCHLORIDE

TRANXENE, CLORAZEPATE DIPOTASSIUM

AKARX INC

* AKARX INC

DOPTELET, AVATROMBOPAG MALEATE

AKCEA THERAPS

* AKCEA THERAPEUTICS INC

TEGSEDI, INOTERSEN SODIUM

AKORN

* AKORN OPERATING CO LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

CEFTRIAXONE, CEFTRIAXONE SODIUM

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

FAMOTIDINE, FAMOTIDINE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

ALBIREO

* ALBIREO AB

BYLVAY, ODEVIXIBAT

ALCON

* ALCON LABORATORIES INC

BSS PLUS, CALCIUM CHLORIDE

BSS, CALCIUM CHLORIDE

MIOSTAT, CARBACHOL

NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

* ALCON RESEARCH LLC

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

ALCON LABS

* ALCON LABORATORIES LTD

TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE

ALCON LABS INC

* ALCON LABORATORIES INC

ALCAINE, PROPARACAINE HYDROCHLORIDE

CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE

CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE

EYSUVIS, LOTEPREDNOL ETABONATE

FLUORESCITE, FLUORESCEIN SODIUM

INVELTYS, LOTEPREDNOL ETABONATE

ISOPTO ATROPINE, ATROPINE SULFATE

MYDRIACYL, TROPICAMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 11

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALCON LABORATORIES INC

PATADAY ONCE DAILY RELIEF, OLOPATADINE HYDROCHLORIDE (OTC)

PATADAY TWICE DAILY RELIEF, OLOPATADINE HYDROCHLORIDE (OTC)

RHOPRESSA, NETARSUDIL MESYLATE

ROCKLATAN, LATANOPROST

SIMBRINZA, BRIMONIDINE TARTRATE

ALCON PHARMS LTD

* ALCON PHARMACEUTICALS LTD

BETADINE, POVIDONE-IODINE

ZADITOR, KETOTIFEN FUMARATE (OTC)

ALEMBIC

* ALEMBIC PHARMACEUTICALS LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

ACYCLOVIR, ACYCLOVIR

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ADAPALENE, ADAPALENE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ASENAPINE MALEATE, ASENAPINE MALEATE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BEPOTASTINE BESILATE, BEPOTASTINE BESILATE

BIMATOPROST, BIMATOPROST

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BROMFENAC SODIUM, BROMFENAC SODIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CARMUSTINE, CARMUSTINE

CELECOXIB, CELECOXIB

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORTHALIDONE, CHLORTHALIDONE

CLARITHROMYCIN, CLARITHROMYCIN

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DAPSONE, DAPSONE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DEFERASIROX, DEFERASIROX

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DESONIDE, DESONIDE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DOCETAXEL, DOCETAXEL

DOCOSANOL, DOCOSANOL (OTC)

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

FEBUXOSTAT, FEBUXOSTAT

FENOFIBRATE (MICRONIZED), FENOFIBRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 12

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALEMBIC PHARMACEUTICALS LTD

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FORMOTEROL FUMARATE, FORMOTEROL FUMARATE

FULVESTRANT, FULVESTRANT

GLYCOPYRROLATE, GLYCOPYRROLATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ITRACONAZOLE, ITRACONAZOLE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LACOSAMIDE, LACOSAMIDE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE, LIDOCAINE

LINEZOLID, LINEZOLID

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METRONIDAZOLE, METRONIDAZOLE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MODAFINIL, MODAFINIL

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MUPIROCIN, MUPIROCIN CALCIUM

NADOLOL, NADOLOL

NIFEDIPINE, NIFEDIPINE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC)

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PACLITAXEL, PACLITAXEL

PIRFENIDONE, PIRFENIDONE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREGABALIN, PREGABALIN

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SELEXIPAG, SELEXIPAG

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TADALAFIL, TADALAFIL

TAVABOROLE, TAVABOROLE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

TERIFLUNOMIDE, TERIFLUNOMIDE

THEOPHYLLINE, THEOPHYLLINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOBRAMYCIN, TOBRAMYCIN

TRAVOPROST, TRAVOPROST

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

ALEMBIC GLOBAL

* ALEMBIC GLOBAL HOLDING SA

TREPROSTINIL, TREPROSTINIL

ALEMBIC LTD
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 13

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALEMBIC LTD

LITHIUM CARBONATE, LITHIUM CARBONATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ALEMBIC PHARMS LTD

* ALEMBIC PHARMACEUTICALS LTD

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DESVENLAFAXINE, DESVENLAFAXINE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

FAMOTIDINE, FAMOTIDINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEFLUNOMIDE, LEFLUNOMIDE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEPROBAMATE, MEPROBAMATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE, METRONIDAZOLE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ALEXZA PHARMS

* ALEXZA PHARMACEUTICALS INC

ADASUVE, LOXAPINE

ALIGNSCIENCE PHARMA

* ALIGNSCIENCE PHARMA INC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

ALIMERA SCIENCES INC

* ALIMERA SCIENCES INC

ILUVIEN, FLUOCINOLONE ACETONIDE

YUTIQ, FLUOCINOLONE ACETONIDE

ALKALOIDA ZRT

* ALKALOIDA CHEMICAL CO ZRT

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

ALKEM

* ALKEM LABORATORIES LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

GABAPENTIN, GABAPENTIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ALKEM LABS LTD

* ALKEM LABORATORIES LTD

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

APREMILAST, APREMILAST

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZATHIOPRINE, AZATHIOPRINE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BREXPIPRAZOLE, BREXPIPRAZOLE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CAPECITABINE, CAPECITABINE

CEFDINIR, CEFDINIR

CEFIXIME, CEFIXIME

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORTHALIDONE, CHLORTHALIDONE

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

COLCHICINE, COLCHICINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 14

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALKEM LABORATORIES LTD

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DABIGATRAN ETEXILATE MESYLATE, DABIGATRAN ETEXILATE MESYLATE

DALFAMPRIDINE, DALFAMPRIDINE

DEFERASIROX, DEFERASIROX

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DROXIDOPA, DROXIDOPA

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ERYTHROMYCIN, ERYTHROMYCIN

ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

EVEROLIMUS, EVEROLIMUS

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

EZETIMIBE, EZETIMIBE

FAMOTIDINE, FAMOTIDINE

FEBUXOSTAT, FEBUXOSTAT

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FINASTERIDE, FINASTERIDE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FOSFOMYCIN TROMETHAMINE, FOSFOMYCIN TROMETHAMINE

GABAPENTIN, GABAPENTIN

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

IBUPROFEN AND FAMOTIDINE, FAMOTIDINE

IBUPROFEN, IBUPROFEN

ITRACONAZOLE, ITRACONAZOLE

LACOSAMIDE, LACOSAMIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE, LIDOCAINE

LINEZOLID, LINEZOLID

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MARINOL, DRONABINOL

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

NIFEDIPINE, NIFEDIPINE

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PREGABALIN, PREGABALIN

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANOLAZINE, RANOLAZINE

RASAGILINE MESYLATE, RASAGILINE MESYLATE

RILUZOLE, RILUZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROFLUMILAST, ROFLUMILAST

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

RUFINAMIDE, RUFINAMIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SIROLIMUS, SIROLIMUS

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, MAGNESIUM SULFATE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TACROLIMUS, TACROLIMUS
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 15

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALKEM LABORATORIES LTD

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TEMAZEPAM, TEMAZEPAM

TICAGRELOR, TICAGRELOR

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOBRAMYCIN, TOBRAMYCIN

TOLVAPTAN, TOLVAPTAN

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALSARTAN, VALSARTAN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VARENICLINE TARTRATE, VARENICLINE TARTRATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VIGABATRIN, VIGABATRIN

ALKERMES

* ALKERMES INC

VIVITROL, NALTREXONE

ALKERMES INC

* ALKERMES INC

ARISTADA INITIO KIT, ARIPIPRAZOLE LAUROXIL

ARISTADA, ARIPIPRAZOLE LAUROXIL

LYBALVI, OLANZAPINE

ALLEGIANCE HLTHCARE

* ALLEGIANCE HEALTHCARE CORP

POVIDONE IODINE, POVIDONE-IODINE (OTC)

ALLERGAN

* ALLERGAN INC

AVAGE, TAZAROTENE

OCUFLOX, OFLOXACIN

TAZORAC, TAZAROTENE

* ALLERGAN PHARMACEUTICAL

BETAGAN, LEVOBUNOLOL HYDROCHLORIDE

* ALLERGAN SALES LLC

AVYCAZ, AVIBACTAM SODIUM

BYSTOLIC, NEBIVOLOL HYDROCHLORIDE

CONDYLOX, PODOFILOX

CRINONE, PROGESTERONE

ESTRACE, ESTRADIOL

INFED, FERRIC OXYHYDROXIDE

OXYTROL, OXYBUTYNIN

RAPAFLO, SILODOSIN

SAPHRIS, ASENAPINE MALEATE

URSO 250, URSODIOL

URSO FORTE, URSODIOL

ALMAJECT

* ALMAJECT INC

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ALMATICA

* ALMATICA PHARMA INC

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

GRALISE, GABAPENTIN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* ALMATICA PHARMA LLC

LOREEV XR, LORAZEPAM

MACROBID, NITROFURANTOIN

MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

VENLAFAXINE BESYLATE, VENLAFAXINE BESYLATE

ZESTORETIC, HYDROCHLOROTHIAZIDE

ALMIRALL

* ALMIRALL LLC

ACTICLATE, DOXYCYCLINE HYCLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 16

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ALMIRALL LLC

ACZONE, DAPSONE

ALTABAX, RETAPAMULIN

AZELEX, AZELAIC ACID

CORDRAN, FLURANDRENOLIDE

KLISYRI, TIRBANIBULIN

SEYSARA, SARECYCLINE HYDROCHLORIDE

VELTIN, CLINDAMYCIN PHOSPHATE

ALNYLAM PHARMS INC

* ALNYLAM PHARMACEUTICALS INC

AMVUTTRA, VUTRISIRAN SODIUM

GIVLAARI, GIVOSIRAN SODIUM

ONPATTRO, PATISIRAN SODIUM

OXLUMO, LUMASIRAN SODIUM

ALTAIRE PHARMS INC

* ALTAIRE PHARMACEUTICALS INC

ALTAFLUOR BENOX, BENOXINATE HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)

OFLOXACIN, OFLOXACIN

ALTATHERA PHARMS LLC

* ALTATHERA PHARMACEUTICALS LLC

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

ALTHERA PHARMS

* ALTHERA PHARMACEUTICALS LLC

LYPQOZET, ATORVASTATIN CALCIUM

ALVOGEN

* ALVOGEN INC

ACETYLCYSTEINE, ACETYLCYSTEINE

BONSITY, TERIPARATIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE, BUPRENORPHINE

CARBIDOPA, CARBIDOPA

DEXAMETHASONE, DEXAMETHASONE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DISULFIRAM, DISULFIRAM

ESTRADIOL, ESTRADIOL

FELBAMATE, FELBAMATE

FLUOCINONIDE, FLUOCINONIDE

HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE

LIDEX, FLUOCINONIDE

MELPHALAN, MELPHALAN

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PREGABALIN, PREGABALIN

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

PYRIMETHAMINE, PYRIMETHAMINE

RIVASTIGMINE, RIVASTIGMINE

THYRO-TABS, LEVOTHYROXINE SODIUM **

UREX, METHENAMINE HIPPURATE

AM REGENT

* AMERICAN REGENT INC

ACETYLCYSTEINE, ACETYLCYSTEINE

ATROPINE SULFATE, ATROPINE SULFATE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CUPRIC SULFATE, CUPRIC SULFATE

CYANOCOBALAMIN, CYANOCOBALAMIN

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DROPERIDOL, DROPERIDOL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 17

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMERICAN REGENT INC

ESTRADIOL VALERATE, ESTRADIOL VALERATE

FOMEPIZOLE, FOMEPIZOLE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INJECTAFER, FERRIC CARBOXYMALTOSE

ISOSULFAN BLUE, ISOSULFAN BLUE

LEVOCARNITINE, LEVOCARNITINE

METHOCARBAMOL, METHOCARBAMOL

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

MULTRYS, CUPRIC SULFATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NITROGLYCERIN, NITROGLYCERIN

OLANZAPINE, OLANZAPINE

PACLITAXEL, PACLITAXEL

POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC

SELENIOUS ACID, SELENIOUS ACID

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TRALEMENT, CUPRIC SULFATE

TRANEXAMIC ACID, TRANEXAMIC ACID

VASOPRESSIN, VASOPRESSIN

VENOFER, FERRIC OXYHYDROXIDE

ZINC SULFATE, ZINC SULFATE

AMARIN PHARMS

* AMARIN PHARMACEUTICALS IRELAND LTD

VASCEPA, ICOSAPENT ETHYL

AMGEN

* AMGEN INC

SENSIPAR, CINACALCET HYDROCHLORIDE

AMGEN INC

* AMGEN INC

CORLANOR, IVABRADINE

CORLANOR, IVABRADINE HYDROCHLORIDE

LUMAKRAS, SOTORASIB

OTEZLA, APREMILAST

AMICI

* AMICI PHARMACEUTICALS LLC

CATAFLAM, DICLOFENAC POTASSIUM

DIGOXIN, DIGOXIN

AMICUS THERAP US

* AMICUS THERAPEUTICS US LLC

GALAFOLD, MIGALASTAT HYDROCHLORIDE

OPFOLDA, MIGLUSTAT

AMIVAS

* AMIVAS INC

ARTESUNATE, ARTESUNATE

AMNEAL

* AMNEAL EU LTD

AMINOCAPROIC ACID, AMINOCAPROIC ACID

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATROPINE SULFATE, ATROPINE SULFATE

AZACITIDINE, AZACITIDINE

BUSULFAN, BUSULFAN

CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CARMUSTINE, CARMUSTINE

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CLOFARABINE, CLOFARABINE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DARUNAVIR, DARUNAVIR

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 18

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL EU LTD

DEXAMETHASONE, DEXAMETHASONE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIFLUPREDNATE, DIFLUPREDNATE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DOCETAXEL, DOCETAXEL

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EPHEDRINE SULFATE, EPHEDRINE SULFATE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETRAVIRINE, ETRAVIRINE

FLUOROMETHOLONE, FLUOROMETHOLONE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FULVESTRANT, FULVESTRANT

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

METYROSINE, METYROSINE

NELARABINE, NELARABINE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OFLOXACIN, OFLOXACIN

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PIRFENIDONE, PIRFENIDONE

PLERIXAFOR, PLERIXAFOR

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC

PREDNISONE, PREDNISONE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

THEOPHYLLINE, THEOPHYLLINE

THIOTHIXENE, THIOTHIXENE

TIOPRONIN, TIOPRONIN

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VASOPRESSIN, VASOPRESSIN

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

* AMNEAL PHARMACEUTICALS LLC

ACTIVELLA, ESTRADIOL

ACYCLOVIR, ACYCLOVIR

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AZATHIOPRINE, AZATHIOPRINE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BACLOFEN, BACLOFEN

BEXAROTENE, BEXAROTENE

BUPRENORPHINE, BUPRENORPHINE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DAPSONE, DAPSONE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 19

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS LLC

DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ELURYNG, ETHINYL ESTRADIOL

ESTRADIOL, ESTRADIOL

ETHINYL ESTRADIOL AND NORELGESTROMIN, ETHINYL ESTRADIOL

FENOFIBRATE, FENOFIBRATE

FLUOCINONIDE, FLUOCINONIDE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LIDOCAINE, LIDOCAINE

LIORESAL, BACLOFEN

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LUBIPROSTONE, LUBIPROSTONE

LYVISPAH, BACLOFEN

MUPIROCIN, MUPIROCIN CALCIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

NAPROXEN, NAPROXEN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

POSACONAZOLE, POSACONAZOLE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RISPERIDONE, RISPERIDONE

RITONAVIR, RITONAVIR

SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE

SIROLIMUS, SIROLIMUS

SPIRONOLACTONE, SPIRONOLACTONE

SUCRALFATE, SUCRALFATE

TAVABOROLE, TAVABOROLE

TESTOSTERONE, TESTOSTERONE

TIGECYCLINE, TIGECYCLINE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOMIG, ZOLMITRIPTAN

AMNEAL PHARM

* AMNEAL PHARMACEUTICAL

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FOLIC ACID, FOLIC ACID

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

AMNEAL PHARMS

* AMNEAL PHARMACEUTICALS

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATOVAQUONE, ATOVAQUONE

CALCITRIOL, CALCITRIOL

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

COLCHICINE, COLCHICINE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC)

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ENTECAVIR, ENTECAVIR
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 20

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESTRADIOL, ESTRADIOL

FELBAMATE, FELBAMATE

GABAPENTIN, GABAPENTIN

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

INDOMETHACIN, INDOMETHACIN

ITRACONAZOLE, ITRACONAZOLE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE, LIDOCAINE

LORAZEPAM, LORAZEPAM

MEROPENEM, MEROPENEM

METAXALONE, METAXALONE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NIACIN, NIACIN

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

TEMOZOLOMIDE, TEMOZOLOMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

WARFARIN SODIUM, WARFARIN SODIUM

* AMNEAL PHARMACEUTICALS HOLDINGS GMBH

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

* AMNEAL PHARMACEUTICALS OF NEW YORK LLC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUDESONIDE, BUDESONIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

CELECOXIB, CELECOXIB

DUTASTERIDE, DUTASTERIDE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

IRBESARTAN, IRBESARTAN

LACOSAMIDE, LACOSAMIDE

LAMOTRIGINE, LAMOTRIGINE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 21

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS OF NEW YORK LLC

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PALIPERIDONE, PALIPERIDONE

PARICALCITOL, PARICALCITOL

PRASUGREL, PRASUGREL HYDROCHLORIDE

RIVASTIGMINE, RIVASTIGMINE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SPIRONOLACTONE, SPIRONOLACTONE

SUCRALFATE, SUCRALFATE

TOBRAMYCIN, TOBRAMYCIN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VIGABATRIN, VIGABATRIN

AMNEAL PHARMS CO

* AMNEAL PHARMACEUTICALS CO GMBH

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARGATROBAN, ARGATROBAN

BUMETANIDE, BUMETANIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORTHALIDONE, CHLORTHALIDONE

CLOBAZAM, CLOBAZAM

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ERYTHROMYCIN, ERYTHROMYCIN

ETHACRYNIC ACID, ETHACRYNIC ACID

ETODOLAC, ETODOLAC

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

EZETIMIBE, EZETIMIBE

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

FUROSEMIDE, FUROSEMIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

NADOLOL, NADOLOL

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

OXAPROZIN, OXAPROZIN

PARICALCITOL, PARICALCITOL

PHYTONADIONE, PHYTONADIONE

PREGABALIN, PREGABALIN

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SILODOSIN, SILODOSIN

TADALAFIL, TADALAFIL

TERIFLUNOMIDE, TERIFLUNOMIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

URSODIOL, URSODIOL

AMNEAL PHARMS NY

* AMNEAL PHARMACEUTICALS NY LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ALPRAZOLAM, ALPRAZOLAM

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

GABAPENTIN, GABAPENTIN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 22

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMNEAL PHARMACEUTICALS NY LLC

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

* AMNEAL PHARMACEUTICALS OF NY LLC

BEXAROTENE, BEXAROTENE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

ISOTRETINOIN, ISOTRETINOIN

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PROGESTERONE, PROGESTERONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

AMNEALS PHARMS

* AMNEALS PHARMACEUTICALS LLC

FAMOTIDINE, FAMOTIDINE

AMPHASTAR PHARM

* AMPHASTAR PHARMACEUTICAL INC

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

AMPHASTAR PHARMS INC

* AMPHASTAR PHARMACEUTICALS INC

BAQSIMI, GLUCAGON

CORTROSYN, COSYNTROPIN

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

GANIRELIX ACETATE, GANIRELIX ACETATE

GLUCAGON, GLUCAGON

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

VASOPRESSIN, VASOPRESSIN

AMRING PHARMS

* AMRING PHARMACEUTICALS INC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LATANOPROST, LATANOPROST

LYSTEDA, TRANEXAMIC ACID

MESALAMINE, MESALAMINE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

AMRYT

* AMRYT PHARMACEUTICALS DAC

FILSUVEZ, BIRCH TRITERPENES

JUXTAPID, LOMITAPIDE MESYLATE

AMTA

* AMTA LABS LTD

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

MESALAMINE, MESALAMINE

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

AMYLYX
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 23

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AMYLYX PHARMACEUTICALS INC

RELYVRIO, SODIUM PHENYLBUTYRATE

ANACOR PHARMS INC

* ANACOR PHARMACEUTICALS INC

EUCRISA, CRISABOROLE

KERYDIN, TAVABOROLE

ANBEX

* ANBEX INC

IOSAT, POTASSIUM IODIDE (OTC)

ANBISON LAB

* ANBISON LABORATORY CO LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

ANCHEN PHARMS

* ANCHEN PHARMACEUTICALS INC

ALISKIREN HEMIFUMARATE, ALISKIREN HEMIFUMARATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

TRETINOIN, TRETINOIN

* ANCHEN PHARMACEUTICALS, INC

ALPRAZOLAM, ALPRAZOLAM

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

ANDA REPOSITORY

* ANDA REPOSITORY LLC

AMCINONIDE, AMCINONIDE

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM, DIATRIZOATE MEGLUMINE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LEVETIRACETAM, LEVETIRACETAM

METAPROTERENOL SULFATE, METAPROTERENOL SULFATE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRIMIDONE, PRIMIDONE

ANDOR PHARMS

* ANDOR PHARMACEUTICALS LLC

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

ANDRX LABS LLC

* ANDRX LABS LLC

FORTAMET, METFORMIN HYDROCHLORIDE

ANI PHARMS

* ANI PHARMACEUTICALS INC

ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

ARIMIDEX, ANASTROZOLE

ATACAND HCT, CANDESARTAN CILEXETIL

ATACAND, CANDESARTAN CILEXETIL

BACLOFEN, BACLOFEN

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BEXAROTENE, BEXAROTENE

BRETHINE, TERBUTALINE SULFATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 24

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ANI PHARMACEUTICALS INC

CASODEX, BICALUTAMIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

CORTENEMA, HYDROCORTISONE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ETODOLAC, ETODOLAC

FELBAMATE, FELBAMATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCONAZOLE, FLUCONAZOLE

GLIPIZIDE, GLIPIZIDE

INDAPAMIDE, INDAPAMIDE

INDERAL LA, PROPRANOLOL HYDROCHLORIDE

INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE

KIONEX, SODIUM POLYSTYRENE SULFONATE

LITHOBID, LITHIUM CARBONATE

LUVOX, FLUVOXAMINE MALEATE

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MIGLUSTAT, MIGLUSTAT

MISOPROSTOL, MISOPROSTOL

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NILUTAMIDE, NILUTAMIDE

OXISTAT, OXICONAZOLE NITRATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PANDEL, HYDROCORTISONE PROBUTATE

PENICILLAMINE, PENICILLAMINE

PINDOLOL, PINDOLOL

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POTASSIUM CITRATE, POTASSIUM CITRATE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PURIFIED CORTROPHIN GEL, CORTICOTROPIN

REGLAN, METOCLOPRAMIDE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

VALPROIC ACID, VALPROIC ACID

VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VEREGEN, SINECATECHINS

ANIMA

* ANIMA PHARMACEUTICALS PVT LTD

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DEXAMETHASONE, DEXAMETHASONE

TRIACIN-C, CODEINE PHOSPHATE

ANNORA

* ANNORA PHARMA PRIVATE LTD

APREMILAST, APREMILAST

DROXIDOPA, DROXIDOPA

LAMIVUDINE, LAMIVUDINE

ANNORA PHARMA

* ANNORA PHARMA PRIVATE LTD

AMINOCAPROIC ACID, AMINOCAPROIC ACID

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

DEFERASIROX, DEFERASIROX

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM, DIATRIZOATE MEGLUMINE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ENALAPRIL MALEATE, ENALAPRIL MALEATE

EPLERENONE, EPLERENONE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 25

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ANNORA PHARMA PRIVATE LTD

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

GLYCOPYRROLATE, GLYCOPYRROLATE

ITRACONAZOLE, ITRACONAZOLE

IVABRADINE HYDROCHLORIDE, IVABRADINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

NABUMETONE, NABUMETONE

OXCARBAZEPINE, OXCARBAZEPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SAPROPTERIN DIHYDROCHLORIDE, SAPROPTERIN DIHYDROCHLORIDE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

THEOPHYLLINE, THEOPHYLLINE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VIGABATRIN, VIGABATRIN

ZAFIRLUKAST, ZAFIRLUKAST

ZILEUTON, ZILEUTON

ANTARES PHARMA INC

* ANTARES PHARMA INC

TLANDO, TESTOSTERONE UNDECANOATE

XYOSTED (AUTOINJECTOR), TESTOSTERONE ENANTHATE

ANTIBIOTICE

* ANTIBIOTICE SA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

ANXIN

* ANXIN PHARMA INC

SEVELAMER CARBONATE, SEVELAMER CARBONATE

APELLIS PHARMS

* APELLIS PHARMACEUTICALS INC

EMPAVELI, PEGCETACOPLAN

SYFOVRE, PEGCETACOPLAN

APGDI

* ASTELLAS PHARMA GLOBAL DEVELOPMENT INC

MYRBETRIQ GRANULES, MIRABEGRON

MYRBETRIQ, MIRABEGRON

APIL

* ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD

ACTONEL, RISEDRONATE SODIUM

ATELVIA, RISEDRONATE SODIUM

LO LOESTRIN FE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

TAYTULLA, ETHINYL ESTRADIOL

APNAR PHARMA LP

* APNAR PHARMA LP

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

APOTEX

* APOTEX INC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACYCLOVIR, ACYCLOVIR

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMBRISENTAN, AMBRISENTAN

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 26

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATOVAQUONE, ATOVAQUONE

ATROPINE SULFATE, ATROPINE SULFATE

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, AZELASTINE HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BEPOTASTINE BESILATE, BEPOTASTINE BESILATE

BICALUTAMIDE, BICALUTAMIDE

BIMATOPROST, BIMATOPROST

BORTEZOMIB, BORTEZOMIB

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BUSULFAN, BUSULFAN

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CELECOXIB, CELECOXIB

CIMETIDINE, CIMETIDINE (OTC)

CYCLOSPORINE, CYCLOSPORINE

DABIGATRAN ETEXILATE MESYLATE, DABIGATRAN ETEXILATE MESYLATE

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DEXAMETHASONE, DEXAMETHASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE

ETODOLAC, ETODOLAC

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GEFITINIB, GEFITINIB

GEMFIBROZIL, GEMFIBROZIL

GLIPIZIDE, GLIPIZIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

ICOSAPENT ETHYL, ICOSAPENT ETHYL

IMATINIB MESYLATE, IMATINIB MESYLATE

LACOSAMIDE, LACOSAMIDE

LAMIVUDINE, LAMIVUDINE

LENALIDOMIDE, LENALIDOMIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

MACITENTAN, MACITENTAN

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MODAFINIL, MODAFINIL

MOMETASONE FUROATE, MOMETASONE FUROATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NILOTINIB HYDROCHLORIDE, NILOTINIB HYDROCHLORIDE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC)

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 27

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC

OMEPRAZOLE, OMEPRAZOLE

OMEPRAZOLE, OMEPRAZOLE (OTC)

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PAXIL CR, PAROXETINE HYDROCHLORIDE

PAXIL, PAROXETINE HYDROCHLORIDE

PAZOPANIB HYDROCHLORIDE, PAZOPANIB HYDROCHLORIDE

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PENICILLAMINE, PENICILLAMINE

PENTOXIFYLLINE, PENTOXIFYLLINE

PIRFENIDONE, PIRFENIDONE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREGABALIN, PREGABALIN

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

REGADENOSON, REGADENOSON

RISEDRONATE SODIUM, RISEDRONATE SODIUM

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SIROLIMUS, SIROLIMUS

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TASIMELTEON, TASIMELTEON

TERIFLUNOMIDE, TERIFLUNOMIDE

TERIPARATIDE, TERIPARATIDE

TETRABENAZINE, TETRABENAZINE

TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE

TIGECYCLINE, TIGECYCLINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLVAPTAN, TOLVAPTAN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRAVOPROST, TRAVOPROST

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE (OTC)

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VARENICLINE TARTRATE, VARENICLINE TARTRATE

VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

APOTEX INC

* APOTEX INC

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

CALCITONIN-SALMON, CALCITONIN SALMON

CARBAMAZEPINE, CARBAMAZEPINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFPROZIL, CEFPROZIL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IMIQUIMOD, IMIQUIMOD

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 28

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* APOTEX INC

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* APOTEX INC ETOBICOKE SITE

ACYCLOVIR, ACYCLOVIR

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

CILOSTAZOL, CILOSTAZOL

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

ETODOLAC, ETODOLAC

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

LEFLUNOMIDE, LEFLUNOMIDE

LORATADINE, LORATADINE (OTC)

MIRTAZAPINE, MIRTAZAPINE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

* APOTEX INC RICHMOND HILL

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BUDESONIDE, BUDESONIDE (OTC)

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

APOTHECON

* APOTHECON INC DIV BRISTOL MYERS SQUIBB

KENALOG-10, TRIAMCINOLONE ACETONIDE

KENALOG-40, TRIAMCINOLONE ACETONIDE

KENALOG-80, TRIAMCINOLONE ACETONIDE

APP PHARMS

* APP PHARMACEUTICALS LLC

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

APPCO

* APPCO PHARMA LLC

ACETAZOLAMIDE, ACETAZOLAMIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORTHALIDONE, CHLORTHALIDONE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

METAXALONE, METAXALONE

MODAFINIL, MODAFINIL

PERPHENAZINE, PERPHENAZINE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

APRECIA PHARMS

* APRECIA PHARMACEUTICALS LLC

SPRITAM, LEVETIRACETAM

APTAPHARMA INC

* APTAPHARMA INC

CHLORZOXAZONE, CHLORZOXAZONE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN (OTC)

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 29

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

AQUESTIVE

* AQUESTIVE THERAPEUTICS INC

EXSERVAN, RILUZOLE

ARBOR PHARMS LLC

* ARBOR PHARMACEUTICALS LLC

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE

ERY-TAB, ERYTHROMYCIN

ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN, ERYTHROMYCIN

EVEKEO, AMPHETAMINE SULFATE

SKLICE, IVERMECTIN (OTC)

ARCUTIS

* ARCUTIS BIOTHERAPEUTICS INC

ZORYVE, ROFLUMILAST

ARDELYX INC

* ARDELYX INC

IBSRELA, TENAPANOR HYDROCHLORIDE

XPHOZAH, TENAPANOR HYDROCHLORIDE

AREVA PHARMS

* AREVA PHARMACEUTICALS INC

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FUROSEMIDE, FUROSEMIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ARMSTRONG PHARMS

* ARMSTRONG PHARMACEUTICALS INC

PRIMATENE MIST, EPINEPHRINE (OTC)

ARNA PHARMA

* ARNA PHARMA PTY LTD

ARIDOL KIT, MANNITOL

ARRAY BIOPHARMA INC

* ARRAY BIOPHARMA INC

BRAFTOVI, ENCORAFENIB

MEKTOVI, BINIMETINIB

ARROW INTL

* ARROW INTERNATIONAL LTD

LENALIDOMIDE, LENALIDOMIDE

ARTHUR GRP

* ARTHUR GROUP LLC

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

ASCEND THERAPS US

* ASCEND THERAPEUTICS US LLC

ESTROGEL, ESTRADIOL

ASCENT PHARMS INC

* ASCENT PHARMACEUTICALS INC

BENZONATATE, BENZONATATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DRONABINOL, DRONABINOL

DUTASTERIDE, DUTASTERIDE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IBUPROFEN AND FAMOTIDINE, FAMOTIDINE

IBUPROFEN, IBUPROFEN (OTC)

ICOSAPENT ETHYL, ICOSAPENT ETHYL

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 30

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ASCENT PHARMACEUTICALS INC

LISINOPRIL, LISINOPRIL

MELOXICAM, MELOXICAM

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PALIPERIDONE, PALIPERIDONE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ASPEN

* ASPEN PHARMA USA INC

ACETYLCYSTEINE, ACETYLCYSTEINE

GLYCOPYRROLATE, GLYCOPYRROLATE

ASPEN GLOBAL INC

* ASPEN GLOBAL INC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CYCLESSA, DESOGESTREL

ASPIRO

* ASPIRO PHARMA LTD

ACETAMINOPHEN, ACETAMINOPHEN

DAPTOMYCIN, DAPTOMYCIN

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LACOSAMIDE, LACOSAMIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUGAMMADEX SODIUM, SUGAMMADEX SODIUM

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ASSERTIO

* ASSERTIO THERAPEUTICS INC

CAMBIA, DICLOFENAC POTASSIUM

ZIPSOR, DICLOFENAC POTASSIUM

ASTELLAS

* ASTELLAS PHARMA US INC

AMBISOME, AMPHOTERICIN B

ASTAGRAF XL, TACROLIMUS

CRESEMBA, ISAVUCONAZONIUM SULFATE

LEXISCAN, REGADENOSON

MYCAMINE, MICAFUNGIN SODIUM

PROGRAF, TACROLIMUS

VEOZAH, FEZOLINETANT

VESICARE LS, SOLIFENACIN SUCCINATE

VESICARE, SOLIFENACIN SUCCINATE

XOSPATA, GILTERITINIB FUMARATE

XTANDI, ENZALUTAMIDE

ASTRAL

* ASTRAL STERITECH PVT LTD

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

ASTRAZENECA

* ASTRAZENECA LP

PULMICORT FLEXHALER, BUDESONIDE

SYMBICORT, BUDESONIDE

* ASTRAZENECA PHARMACEUTICALS LP

AIRSUPRA, ALBUTEROL SULFATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 31

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* ASTRAZENECA PHARMACEUTICALS LP

BEVESPI AEROSPHERE, FORMOTEROL FUMARATE

BRILINTA, TICAGRELOR

DALIRESP, ROFLUMILAST

FASLODEX, FULVESTRANT

IRESSA, GEFITINIB

KOSELUGO, SELUMETINIB SULFATE

LOKELMA, SODIUM ZIRCONIUM CYCLOSILICATE

LYNPARZA, OLAPARIB

NEXIUM IV, ESOMEPRAZOLE SODIUM

NEXIUM, ESOMEPRAZOLE MAGNESIUM

PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)

PULMICORT RESPULES, BUDESONIDE

SEROQUEL, QUETIAPINE FUMARATE

SYMBICORT AEROSPHERE, BUDESONIDE

TAGRISSO, OSIMERTINIB MESYLATE

TRUQAP, CAPIVASERTIB

* ASTRAZENECA UK LTD

CALQUENCE, ACALABRUTINIB

CALQUENCE, ACALABRUTINIB MALEATE

SEROQUEL XR, QUETIAPINE FUMARATE

ASTRAZENECA AB

* ASTRAZENECA AB

BREZTRI AEROSPHERE, BUDESONIDE

BYDUREON BCISE, EXENATIDE SYNTHETIC

BYETTA, EXENATIDE SYNTHETIC

FARXIGA, DAPAGLIFLOZIN

QTERN, DAPAGLIFLOZIN

SYMLIN, PRAMLINTIDE ACETATE

XIGDUO XR, DAPAGLIFLOZIN

ASTRAZENECA LP

* ASTRAZENECA LP

NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC)

ATHEM

* ATHEM HOLDINGS LLC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

ATHENA

* ATHENA BIOSCIENCE LLC

NEXICLON XR, CLONIDINE

QDOLO, TRAMADOL HYDROCHLORIDE

ATLAS PHARMS LLC

* ATLAS PHARMACEUTICALS LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ATNAHS PHARMA US

* ATNAHS PHARMA US LTD

ANAPROX DS, NAPROXEN SODIUM

EC-NAPROSYN, NAPROXEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

NAPROSYN, NAPROXEN

ATON

* ATON PHARMA INC

LODOSYN, CARBIDOPA

AUCTA

* AUCTA PHARMACEUTICALS INC

DEFERASIROX, DEFERASIROX

FORMOTEROL FUMARATE, FORMOTEROL FUMARATE

MOTPOLY XR, LACOSAMIDE

OXCARBAZEPINE, OXCARBAZEPINE

VIGADRONE, VIGABATRIN

AURINIA

* AURINIA PHARMACEUTICALS INC

LUPKYNIS, VOCLOSPORIN

AUROBINDO
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 32

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

AMOXICILLIN, AMOXICILLIN

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLARITHROMYCIN, CLARITHROMYCIN

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NEVIRAPINE, NEVIRAPINE

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARMA

* AUROBINDO PHARMA LTD

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACYCLOVIR, ACYCLOVIR

AFIRMELLE, ETHINYL ESTRADIOL

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALPRAZOLAM, ALPRAZOLAM

AMBRISENTAN, AMBRISENTAN

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATENOLOL, ATENOLOL

ATHENTIA NEXT, LEVONORGESTREL (OTC)

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

AUROVELA 1.5/30, ETHINYL ESTRADIOL

AUROVELA 1/20, ETHINYL ESTRADIOL

AUROVELA 24 FE, ETHINYL ESTRADIOL

AUROVELA FE 1.5/30, ETHINYL ESTRADIOL

AUROVELA FE 1/20, ETHINYL ESTRADIOL

AYUNA, ETHINYL ESTRADIOL

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CARBIDOPA, CARBIDOPA

CARISOPRODOL, CARISOPRODOL

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CELECOXIB, CELECOXIB

CEPHALEXIN, CEPHALEXIN

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

CLOZAPINE, CLOZAPINE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYONANZ, ETHINYL ESTRADIOL

DALFAMPRIDINE, DALFAMPRIDINE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIMETHYL FUMARATE, DIMETHYL FUMARATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 33

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

EFAVIRENZ, EFAVIRENZ

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

EMZAHH, NORETHINDRONE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENTECAVIR, ENTECAVIR

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

ESZOPICLONE, ESZOPICLONE

EZETIMIBE, EZETIMIBE

FAMOTIDINE, FAMOTIDINE (OTC)

FENOFIBRATE, FENOFIBRATE

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

INCASSIA, NORETHINDRONE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

KALLIGA, DESOGESTREL

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LEFLUNOMIDE, LEFLUNOMIDE

LEVETIRACETAM, LEVETIRACETAM

LO SIMPESSE, ETHINYL ESTRADIOL

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MELOXICAM, MELOXICAM

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

NEXESTA FE, ETHINYL ESTRADIOL

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

NIFEDIPINE, NIFEDIPINE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN

NITROGLYCERIN, NITROGLYCERIN

NYLIA 1/35, ETHINYL ESTRADIOL

NYLIA 7/7/7, ETHINYL ESTRADIOL

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OSHIH, ETHINYL ESTRADIOL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 34

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREGABALIN, PREGABALIN

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RANOLAZINE, RANOLAZINE

RIBAVIRIN, RIBAVIRIN

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RUFINAMIDE, RUFINAMIDE

SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SIMLIYA, DESOGESTREL

SIMPESSE, ETHINYL ESTRADIOL

SIMVASTATIN, SIMVASTATIN

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

SPIRONOLACTONE, SPIRONOLACTONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TERIFLUNOMIDE, TERIFLUNOMIDE

TOPIRAMATE, TOPIRAMATE

TORSEMIDE, TORSEMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRANDOLAPRIL, TRANDOLAPRIL

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRI-LO-MILI, ETHINYL ESTRADIOL

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZAFIRLUKAST, ZAFIRLUKAST

ZALEPLON, ZALEPLON

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

AUROBINDO PHARMA LTD

* AUROBINDO PHARMA LIMITED

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

LEVOFLOXACIN, LEVOFLOXACIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

* AUROBINDO PHARMA LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, ABACAVIR SULFATE

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 35

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ARIPIPRAZOLE, ARIPIPRAZOLE

ARMODAFINIL, ARMODAFINIL

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BACLOFEN, BACLOFEN

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CEFIXIME, CEFIXIME

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

COLCHICINE, COLCHICINE

DARUNAVIR, DARUNAVIR

DEFERASIROX, DEFERASIROX

DIAZEPAM, DIAZEPAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DIGOXIN, DIGOXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOFETILDE, DOFETILIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DROXIDOPA, DROXIDOPA

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

EFAVIRENZ, EFAVIRENZ

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

EMTRICITABINE, EMTRICITABINE

ENTACAPONE, ENTACAPONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

FAMCICLOVIR, FAMCICLOVIR

FAMOTIDINE, FAMOTIDINE

FEBUXOSTAT, FEBUXOSTAT

FELODIPINE, FELODIPINE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE (OTC)

FINASTERIDE, FINASTERIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUCYTOSINE, FLUCYTOSINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

GLIMEPIRIDE, GLIMEPIRIDE

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

HYDROCORTISONE, HYDROCORTISONE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

ICLEVIA, ETHINYL ESTRADIOL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 36

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LACOSAMIDE, LACOSAMIDE

LACTULOSE, LACTULOSE

LANSOPRAZOLE, LANSOPRAZOLE

LO-ZUMANDIMINE, DROSPIRENONE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METHOCARBAMOL, METHOCARBAMOL

METRONIDAZOLE, METRONIDAZOLE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MILI, ETHINYL ESTRADIOL

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

MODAFINIL, MODAFINIL

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

NIACIN, NIACIN

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

PREDNISONE, PREDNISONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PYRIMETHAMINE, PYRIMETHAMINE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RAMELTEON, RAMELTEON

RAMIPRIL, RAMIPRIL

REPAGLINIDE, REPAGLINIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RISPERIDONE, RISPERIDONE

RITONAVIR, RITONAVIR

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROFLUMILAST, ROFLUMILAST

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

TADALAFIL, TADALAFIL

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRI-MILI, ETHINYL ESTRADIOL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 37

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUROBINDO PHARMA LTD

URSODIOL, URSODIOL

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VIGABATRIN, VIGABATRIN

VORICONAZOLE, VORICONAZOLE

ZONISAMIDE, ZONISAMIDE

ZUMANDIMINE, DROSPIRENONE

* AUROBINDO PHARMA LTD INC

ZIDOVUDINE, ZIDOVUDINE

AUROBINDO PHARMA USA

* AUROBINDO PHARMA USA INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BUDESONIDE, BUDESONIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLONAZEPAM, CLONAZEPAM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

ELIMITE, PERMETHRIN

GLIPIZIDE, GLIPIZIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

MAXZIDE, HYDROCHLOROTHIAZIDE

MAXZIDE-25, HYDROCHLOROTHIAZIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PINDOLOL, PINDOLOL

RASAGILINE MESYLATE, RASAGILINE MESYLATE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

AUROLIFE PHARMA LLC

* AUROLIFE PHARMA LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC)

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

LORAZEPAM, LORAZEPAM

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

AUSTARPHARMA

* AUSTARPHARMA LLC

FENOFIBRATE, FENOFIBRATE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TADALAFIL, TADALAFIL

AUSTARPHARMA LLC

* AUSTARPHARMA LLC

METHOCARBAMOL, METHOCARBAMOL

AUXILIUM PHARMS INC

* AUXILIUM PHARMACEUTICALS INC

TESTOPEL, TESTOSTERONE

AUXILIUM PHARMS LLC

* AUXILIUM PHARMACEUTICALS LLC

EDEX, ALPROSTADIL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 38

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AUXILIUM PHARMACEUTICALS LLC

TESTIM, TESTOSTERONE

THEO-24, THEOPHYLLINE

AVADEL CNS

* AVADEL CNS PHARMACEUTICALS LLC

LUMRYZ, SODIUM OXYBATE

AVANIR PHARMS

* AVANIR PHARMACEUTICALS INC

NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE

AVANTHI INC

* AVANTHI INC

CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE

INDOMETHACIN, INDOMETHACIN

LOMAIRA, PHENTERMINE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

AVEMA PHARMA

* AVEMA PHARMA SOLUTIONS

IBUPROFEN, IBUPROFEN (OTC)

AVENT

* AVENT INC

PYTEST, UREA, C-14

AVEO PHARMS

* AVEO PHARMACEUTICALS INC

FOTIVDA, TIVOZANIB HYDROCHLORIDE

AVERITAS

* AVERITAS PHARMA INC

QUTENZA, CAPSAICIN

AVET

* AVET PHARMACEUTICALS INC

DOXERCALCIFEROL, DOXERCALCIFEROL

AVET LIFESCIENCES

* AVET LIFESCIENCES LTD

ACARBOSE, ACARBOSE

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ADENOSINE, ADENOSINE

AMIKACIN SULFATE, AMIKACIN SULFATE

BICNU, CARMUSTINE

CIDOFOVIR, CIDOFOVIR

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

FUROSEMIDE, FUROSEMIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROPOFOL, PROPOFOL

TRANEXAMIC ACID, TRANEXAMIC ACID

ZOLEDRONIC ACID, ZOLEDRONIC ACID

* AVET LIFESCIENCES PRIVATE LTD

FOSCARNET SODIUM, FOSCARNET SODIUM

NEOSTIGMINE METHYSULFATE, NEOSTIGMINE METHYLSULFATE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

AVEVA

* AVEVA DRUG DELIVERY SYSTEMS INC

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE, BUPRENORPHINE

CLONIDINE, CLONIDINE

FENTANYL-100, FENTANYL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 39

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** A **

* AVEVA DRUG DELIVERY SYSTEMS INC

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

NICOTINE, NICOTINE (OTC)

AVID RADIOPHARMS INC

* AVID RADIOPHARMACEUTICALS INC

AMYVID, FLORBETAPIR F-18

TAUVID, FLORTAUCIPIR F-18

AVION PHARMS

* AVION PHARMACEUTICALS LLC

BALCOLTRA, ETHINYL ESTRADIOL

DHIVY, CARBIDOPA

PONSTEL, MEFENAMIC ACID

AVONDALE PHARMS

* AVONDALE PHARMACEUTICALS LLC

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

MELOXICAM, MELOXICAM

NIACOR, NIACIN

AXSOME

* AXSOME THERAPEUTICS INC

AUVELITY, BUPROPION HYDROCHLORIDE

AXSOME MALTA

* AXSOME MALTA LTD

SUNOSI, SOLRIAMFETOL HYDROCHLORIDE

AYANA PHARMA LTD

* AYANA PHARMA LTD

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

AYTU

* AYTU BIOSCIENCE INC

KARBINAL ER, CARBINOXAMINE MALEATE

AYTU BIOPHARMA

* AYTU BIOPHARMA INC

METADATE CD, METHYLPHENIDATE HYDROCHLORIDE

AZURITY

* AZURITY PHARMACEUTICALS INC

BIDIL, HYDRALAZINE HYDROCHLORIDE

E.E.S., ERYTHROMYCIN ETHYLSUCCINATE

EDARBI, AZILSARTAN KAMEDOXOMIL

EDARBYCLOR, AZILSARTAN KAMEDOXOMIL

EPANED, ENALAPRIL MALEATE

EPRONTIA, TOPIRAMATE

ERYPED, ERYTHROMYCIN ETHYLSUCCINATE

EVEKEO ODT, AMPHETAMINE SULFATE

FIRVANQ KIT, VANCOMYCIN HYDROCHLORIDE

FLEQSUVY, BACLOFEN

GLIADEL, CARMUSTINE

HORIZANT, GABAPENTIN ENACARBIL

KATERZIA, AMLODIPINE BENZOATE

KONVOMEP, OMEPRAZOLE

NYMALIZE, NIMODIPINE

QBRELIS, LISINOPRIL

SOTYLIZE, SOTALOL HYDROCHLORIDE

THYQUIDITY, LEVOTHYROXINE SODIUM

TRIPTODUR KIT, TRIPTORELIN PAMOATE

XATMEP, METHOTREXATE SODIUM

ZONISADE, ZONISAMIDE

** B **

B BRAUN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 40

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINO ACIDS, AMINO ACIDS

BALANCED SALT, CALCIUM CHLORIDE

CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM

CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE

CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM

CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM

DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL

METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE

NUTRILIPID 10%, SOYBEAN OIL

NUTRILIPID 20%, SOYBEAN OIL

PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 41

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* B BRAUN MEDICAL INC

POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

TROPHAMINE 10%, AMINO ACIDS

TROPHAMINE, AMINO ACIDS

B BRAUN MEDICAL INC

* B BRAUN MEDICAL INC

ACETAMINOPHEN, ACETAMINOPHEN

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

CALCIUM GLUCONATE, CALCIUM GLUCONATE

HEPARIN SODIUM, HEPARIN SODIUM

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINER, MEROPENEM

BAJAJ
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 42

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAJAJ MEDICAL

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

LACTULOSE, LACTULOSE

* BAJAJ MEDICAL LLC

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

BAMF

* BAMF HEALTH INC

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

BANNER LIFE SCIENCES

* BANNER LIFE SCIENCES LLC

BAFIERTAM, MONOMETHYL FUMARATE

BARR

* BARR LABORATORIES INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

ARANELLE, ETHINYL ESTRADIOL

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BALZIVA-28, ETHINYL ESTRADIOL

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

DANAZOL, DANAZOL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIPYRIDAMOLE, DIPYRIDAMOLE

DUTASTERIDE, DUTASTERIDE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ESTRADIOL AND NORGESTIMATE, ESTRADIOL

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

HYDROXYUREA, HYDROXYUREA

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

ISONIAZID, ISONIAZID

JUNEL 1.5/30, ETHINYL ESTRADIOL

JUNEL 1/20, ETHINYL ESTRADIOL

JUNEL FE 1.5/30, ETHINYL ESTRADIOL

JUNEL FE 1/20, ETHINYL ESTRADIOL

KARIVA, DESOGESTREL

KELNOR, ETHINYL ESTRADIOL

LESSINA-28, ETHINYL ESTRADIOL

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NIACIN, NIACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORTREL 0.5/35-28, ETHINYL ESTRADIOL

NORTREL 1/35-21, ETHINYL ESTRADIOL

NORTREL 1/35-28, ETHINYL ESTRADIOL

NORTREL 7/7/7, ETHINYL ESTRADIOL

PORTIA-28, ETHINYL ESTRADIOL

SPRINTEC, ETHINYL ESTRADIOL

TREXALL, METHOTREXATE SODIUM

TRI-LEGEST FE, ETHINYL ESTRADIOL

TRI-SPRINTEC, ETHINYL ESTRADIOL

WARFARIN SODIUM, WARFARIN SODIUM

* BARR LABORATORIES INC A WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

LANTHANUM CARBONATE, LANTHANUM CARBONATE

* BARR PHARMACEUTICALS

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

BARR LABS INC

* BARR LABORATORIES INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 43

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BARR LABORATORIES INC

ACITRETIN, ACITRETIN

CLOZAPINE, CLOZAPINE

ESTRADIOL, ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC)

TRETINOIN, TRETINOIN

TRI LO SPRINTEC, ETHINYL ESTRADIOL

BAUSCH

* BAUSCH HEALTH AMERICAS INC

ACANYA, BENZOYL PEROXIDE

BRYHALI, HALOBETASOL PROPIONATE

DUOBRII, HALOBETASOL PROPIONATE

EDECRIN, ETHACRYNATE SODIUM

EDECRIN, ETHACRYNIC ACID

EFUDEX, FLUOROURACIL

JUBLIA, EFINACONAZOLE

LOCOID, HYDROCORTISONE BUTYRATE

ONEXTON, BENZOYL PEROXIDE

OXSORALEN-ULTRA, METHOXSALEN

SYPRINE, TRIENTINE HYDROCHLORIDE

* BAUSCH HEALTH IRELAND LTD

TARGRETIN, BEXAROTENE

* BAUSCH HEALTH US LLC

AMMONUL, SODIUM BENZOATE

ANCOBON, FLUCYTOSINE

APLENZIN, BUPROPION HYDROBROMIDE

ARAZLO, TAZAROTENE

ATIVAN, LORAZEPAM

CABTREO, ADAPALENE

CARDIZEM CD, DILTIAZEM HYDROCHLORIDE

CARDIZEM LA, DILTIAZEM HYDROCHLORIDE

CARDIZEM, DILTIAZEM HYDROCHLORIDE

CESAMET, NABILONE

CLINDAGEL, CLINDAMYCIN PHOSPHATE

DEMSER, METYROSINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIASTAT ACUDIAL, DIAZEPAM

DIASTAT, DIAZEPAM

ELIDEL, PIMECROLIMUS

FLUNISOLIDE, FLUNISOLIDE

GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

ISORDIL, ISOSORBIDE DINITRATE

KLARON, SULFACETAMIDE SODIUM

LIBRAX, CHLORDIAZEPOXIDE HYDROCHLORIDE

LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE

LOCOID, HYDROCORTISONE BUTYRATE

LOPROX, CICLOPIROX

LUZU, LULICONAZOLE

MESTINON, PYRIDOSTIGMINE BROMIDE

METROGEL-VAGINAL, METRONIDAZOLE

MIGRANAL, DIHYDROERGOTAMINE MESYLATE

MINOCIN, MINOCYCLINE HYDROCHLORIDE

NORITATE, METRONIDAZOLE

RETIN-A MICRO, TRETINOIN

RETIN-A, TRETINOIN

RETIN-A-MICRO, TRETINOIN

SOLODYN, MINOCYCLINE HYDROCHLORIDE

TASMAR, TOLCAPONE

TIAZAC, DILTIAZEM HYDROCHLORIDE

VANOS, FLUOCINONIDE

VASERETIC, ENALAPRIL MALEATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 44

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAUSCH HEALTH US LLC

VASOTEC, ENALAPRIL MALEATE

VIRAZOLE, RIBAVIRIN

WELLBUTRIN XL, BUPROPION HYDROCHLORIDE

XENAZINE, TETRABENAZINE

XERESE, ACYCLOVIR

ZELAPAR, SELEGILINE HYDROCHLORIDE

ZIANA, CLINDAMYCIN PHOSPHATE

ZOVIRAX, ACYCLOVIR

ZYCLARA, IMIQUIMOD

BAUSCH AND LOMB

* BAUSCH AND LOMB INC

ALAWAY, KETOTIFEN FUMARATE (OTC)

ALREX, LOTEPREDNOL ETABONATE

BESIVANCE, BESIFLOXACIN HYDROCHLORIDE

BRINZOLAMIDE, BRINZOLAMIDE

CHILDREN'S ALAWAY, KETOTIFEN FUMARATE (OTC)

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM

ISTALOL, TIMOLOL MALEATE

LATANOPROST, LATANOPROST

LOTEMAX, LOTEPREDNOL ETABONATE

MIOCHOL-E, ACETYLCHOLINE CHLORIDE

OFLOXACIN, OFLOXACIN

OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)

PROLENSA, BROMFENAC SODIUM

RETISERT, FLUOCINOLONE ACETONIDE

SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TIMOLOL MALEATE, TIMOLOL MALEATE

TROPICAMIDE, TROPICAMIDE

VYZULTA, LATANOPROSTENE BUNOD

ZIRGAN, GANCICLOVIR

ZYLET, LOTEPREDNOL ETABONATE

* BAUSCH AND LOMB PHARMACEUTICALS INC

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXASPORIN, DEXAMETHASONE

ERYTHROMYCIN, ERYTHROMYCIN

GENTAMICIN SULFATE, GENTAMICIN SULFATE

LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC

OFLOXACIN, OFLOXACIN

OTICAIR, HYDROCORTISONE

PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TROPICAMIDE, TROPICAMIDE

BAUSCH AND LOMB INC

* BAUSCH AND LOMB INC

ALAWAY, KETOTIFEN FUMARATE (OTC)

ATROPINE SULFATE, ATROPINE SULFATE

BEPREVE, BEPOTASTINE BESILATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 45

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAUSCH AND LOMB INC

LACRISERT, HYDROXYPROPYL CELLULOSE

LOTEMAX SM, LOTEPREDNOL ETABONATE

LOTEMAX, LOTEPREDNOL ETABONATE

LUMIFY, BRIMONIDINE TARTRATE (OTC)

METHAZOLAMIDE, METHAZOLAMIDE

MIEBO, PERFLUOROHEXYLOCTANE

TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE

TIMOPTIC, TIMOLOL MALEATE

TIMOPTIC-XE, TIMOLOL MALEATE

XIPERE, TRIAMCINOLONE ACETONIDE

BAUSCH LOMB IRELAND

* BAUSCH AND LOMB IRELAND LTD

FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE, BENOXINATE HYDROCHLORIDE

TETRACAINE HYDROCHLORIDE, TETRACAINE HYDROCHLORIDE

BAXTER HLTHCARE

* BAXTER HEALTHCARE CORP

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE

BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

BREVIBLOC, ESMOLOL HYDROCHLORIDE

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM

CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS

CLINIMIX E 2.75/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CLINIMIX E 2.75/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CLINIMIX E 2.75/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC

CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/15 SULFITE FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/20 SULFITE FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,

CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,

CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

CYTOXAN, CYCLOPHOSPHAMIDE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND ELECTROLYTE NO. 48 IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 46

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,

DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL LOW CALCIUM W/DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

EXTRANEAL, ICODEXTRIN

FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE

FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FORANE, ISOFLURANE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

IFEX, IFOSFAMIDE

LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE

MESNEX, MESNA

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM

NEXTERONE, AMIODARONE HYDROCHLORIDE

NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN

OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 10% IN WATER, MANNITOL

OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 15% IN WATER, MANNITOL

OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 20% IN WATER, MANNITOL

OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL

OSMITROL 5% IN WATER, MANNITOL

PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 47

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SEVOFLURANE, SEVOFLURANE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

STERILE WATER, STERILE WATER FOR IRRIGATION

SUPRANE, DESFLURANE

TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE

TIS-U-SOL, MAGNESIUM SULFATE

TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS

TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS

VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV

PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS

BAXTER HLTHCARE CORP

* BAXTER HEALTHCARE CORP

ACETAMINOPHEN, ACETAMINOPHEN

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BORTEZOMIB, BORTEZOMIB

CEFAZOLIN IN PLASTIC CONTAINER, CEFAZOLIN SODIUM

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CLINDAMYCIN PHOSPHATE IN 0.9% SODIUM CHLORIDE, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLINOLIPID 20%, OLIVE OIL

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE, DAPTOMYCIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

EPTIFIBATIDE, EPTIFIBATIDE

FLUMAZENIL, FLUMAZENIL

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FUROSEMIDE, FUROSEMIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOFLOXACIN, LEVOFLOXACIN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 48

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAXTER HEALTHCARE CORP

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MICAFUNGIN IN SODIUM CHLORIDE 0.9%, MICAFUNGIN SODIUM

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PHOXILLUM B22K 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PHOXILLUM BK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE

REGADENOSON, REGADENOSON

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TRANSDERM SCOP, SCOPOLAMINE

VASOPRESSIN IN SODIUM CHLORIDE 0.9%, VASOPRESSIN

ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM

* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE

BAYER

* BAYER HEALTHCARE LLC

ALEVE, NAPROXEN SODIUM (OTC)

BAYER HEALTHCARE

* BAYER HEALTHCARE PHARMACEUTICALS INC

LAMPIT, NIFURTIMOX

NUBEQA, DAROLUTAMIDE

VITRAKVI, LAROTRECTINIB SULFATE

BAYER HEALTHCARE LLC

* BAYER HEALTHCARE LLC

CHILDREN'S CLARITIN, LORATADINE (OTC)

CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)

CLARITIN HIVES RELIEF, LORATADINE (OTC)

CLARITIN REDITABS, LORATADINE (OTC)

CLARITIN, LORATADINE (OTC)

CLARITIN-D 24 HOUR, LORATADINE (OTC)

CLARITIN-D, LORATADINE (OTC)

LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)

MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)

BAYER HLTHCARE

* BAYER HEALTHCARE CONSUMER CARE

ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

ASTEPRO ALLERGY, AZELASTINE HYDROCHLORIDE (OTC)

CHILDREN'S ASTEPRO ALLERGY, AZELASTINE HYDROCHLORIDE (OTC)

* BAYER HEALTHCARE PHARMACEUTICALS INC

ADEMPAS, RIOCIGUAT

ANGELIQ, DROSPIRENONE

BEYAZ, DROSPIRENONE

BILTRICIDE, PRAZIQUANTEL

CIPRO, CIPROFLOXACIN

CIPRO, CIPROFLOXACIN HYDROCHLORIDE

CLIMARA PRO, ESTRADIOL

CLIMARA, ESTRADIOL

EOVIST, GADOXETATE DISODIUM

GADAVIST, GADOBUTROL

KERENDIA, FINERENONE

KYLEENA, LEVONORGESTREL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 49

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BAYER HEALTHCARE PHARMACEUTICALS INC

MENOSTAR, ESTRADIOL

MIRENA, LEVONORGESTREL

NATAZIA, DIENOGEST

NEXAVAR, SORAFENIB TOSYLATE

SAFYRAL, DROSPIRENONE

SKYLA, LEVONORGESTREL

STIVARGA, REGORAFENIB

ULTRAVIST (PHARMACY BULK), IOPROMIDE

ULTRAVIST 300, IOPROMIDE

ULTRAVIST 370, IOPROMIDE

VITRAKVI, LAROTRECTINIB SULFATE

XOFIGO, RADIUM RA-223 DICHLORIDE

YASMIN, DROSPIRENONE

YAZ, DROSPIRENONE

BAYSHORE PHARMS LLC

* BAYSHORE PHARMACEUTICALS LLC

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

ETODOLAC, ETODOLAC

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

METOLAZONE, METOLAZONE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PINDOLOL, PINDOLOL

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

BDSI

* BIODELIVERY SCIENCES INTERNATIONAL INC

BELBUCA, BUPRENORPHINE HYDROCHLORIDE

SYMPROIC, NALDEMEDINE TOSYLATE

BE PHARMS

* BE PHARMACEUTICALS AG

DAPTOMYCIN, DAPTOMYCIN

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

HEPARIN SODIUM, HEPARIN SODIUM

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

BECTON DICKINSON

* BECTON DICKINSON AND CO

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

E-Z SCRUB 201, POVIDONE-IODINE (OTC)

E-Z SCRUB 241, POVIDONE-IODINE (OTC)

BECTON DICKINSON CO

* BECTON DICKINSON AND CO

CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)

BEIGENE

* BEIGENE USA INC

BRUKINSA, ZANUBRUTINIB

BEIJING

* BEIJING SCIECURE PHARMACEUTICAL CO LTD

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

FOSCARNET SODIUM, FOSCARNET SODIUM

BEIJING TIDE PHARM

* BEIJING TIDE PHARMACEUTICAL CO LTD

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

BEIJING YILING

* BEIJING YILING BIO-ENGEERING AND TECHNOLOGY CO LTD
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 50

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BEIJING YILING BIO-ENGEERING AND TECHNOLOGY CO LTD

ANASTROZOLE, ANASTROZOLE

LETROZOLE, LETROZOLE

BELCHER

* BELCHER PHARMACEUTICALS LLC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

CEFIXIME, CEFIXIME

CHLORZOXAZONE, CHLORZOXAZONE

GABAPENTIN, GABAPENTIN

LEVETIRACETAM, LEVETIRACETAM

MEFENAMIC ACID, MEFENAMIC ACID

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

TACROLIMUS, TACROLIMUS

BELCHER PHARMS

* BELCHER PHARMACEUTICALS LLC

CEPHALEXIN, CEPHALEXIN

DESLORATADINE, DESLORATADINE

BELOTECA

* BELOTECA INC

DAPSONE, DAPSONE

DIAZEPAM, DIAZEPAM

THIOTEPA, THIOTEPA

BENUVIA OPERATIONS

* BENUVIA OPERATIONS LLC

SYNDROS, DRONABINOL

BEOWULF ASSET

* BEOWULF ASSET MANAGEMENT LP

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

NYSTATIN, NYSTATIN

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

BESINS HLTHCARE

* BESINS HEALTHCARE IRELAND LTD

ANDROGEL, TESTOSTERONE

BEXIMCO PHARMS USA

* BEXIMCO PHARMACEUTICALS USA INC

BACLOFEN, BACLOFEN

CARBIDOPA, CARBIDOPA

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NADOLOL, NADOLOL

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

BEXIMCO USA

* BEXIMCO PHARMACEUTICALS USA INC

CARVEDILOL, CARVEDILOL

BIOCODEX SA

* BIOCODEX SA

DIACOMIT, STIRIPENTOL

BIOCON PHARMA

* BIOCON PHARMA INC

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

* BIOCON PHARMA LTD

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

EVEROLIMUS, EVEROLIMUS

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

POSACONAZOLE, POSACONAZOLE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 51

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BIOCON PHARMA LTD

SIMVASTATIN, SIMVASTATIN

TACROLIMUS, TACROLIMUS

TERIFLUNOMIDE, TERIFLUNOMIDE

BIOCRYST

* BIOCRYST PHARMACEUTICALS INC

ORLADEYO, BEROTRALSTAT HYDROCHLORIDE

RAPIVAB, PERAMIVIR

BIOFRONTERA

* BIOFRONTERA BIOSCIENCE GMBH

AMELUZ, AMINOLEVULINIC ACID HYDROCHLORIDE

BIOGEN IDEC

* BIOGEN IDEC INC

SPINRAZA, NUSINERSEN SODIUM

BIOGEN INC

* BIOGEN INC

TECFIDERA, DIMETHYL FUMARATE

VUMERITY, DIROXIMEL FUMARATE

ZURZUVAE, ZURANOLONE

BIOGEN MA

* BIOGEN MA INC

QALSODY, TOFERSEN

BIOLINERX LTD

* BIOLINERX LTD

APHEXDA, MOTIXAFORTIDE ACETATE

BIOMARIN PHARM

* BIOMARIN PHARMACEUTICAL INC

KUVAN, SAPROPTERIN DIHYDROCHLORIDE

VOXZOGO, VOSORITIDE

BIOMEDCL RES FDN

* BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

BIONPHARMA

* BIONPHARMA INC

ACETAMINOPHEN AND IBUPROFEN, ACETAMINOPHEN (OTC)

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

ATOVAQUONE, ATOVAQUONE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BENZONATATE, BENZONATATE

BEXAROTENE, BEXAROTENE

CALCITRIOL, CALCITRIOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DEFERASIROX, DEFERASIROX

DEXAMETHASONE, DEXAMETHASONE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DOFETILIDE, DOFETILIDE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

DROXIDOPA, DROXIDOPA

DUTASTERIDE, DUTASTERIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETHOSUXIMIDE, ETHOSUXIMIDE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 52

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BIONPHARMA INC

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEVETIRACETAM, LEVETIRACETAM

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

METHIMAZOLE, METHIMAZOLE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MIDOL LIQUID GELS, IBUPROFEN (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OXCARBAZEPINE, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PARICALCITOL, PARICALCITOL

POTASSIUM CITRATE, POTASSIUM CITRATE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROGESTERONE, PROGESTERONE

RUFINAMIDE, RUFINAMIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

TETRABENAZINE, TETRABENAZINE

THEOPHYLLINE, THEOPHYLLINE

VALPROIC ACID, VALPROIC ACID

VITAMIN D, ERGOCALCIFEROL

ZONISAMIDE, ZONISAMIDE

BIOXCEL

* BIOXCEL THERAPEUTICS INC

IGALMI, DEXMEDETOMIDINE HYDROCHLORIDE

BLUE EARTH

* BLUE EARTH DIAGNOSTICS LTD

AXUMIN, FLUCICLOVINE F-18

POSLUMA, FLOTUFOLASTAT F-18 GALLIUM

BLUE WATER BIOTECH

* BLUE WATER BIOTECH INC

ENTADFI, FINASTERIDE

BLUEPHARMA INDUSTRIA

* BLUEPHARMA INDUSTRIA FARMACEUTICA SA

DROXIDOPA, DROXIDOPA

BLUEPRINT MEDICINES

* BLUEPRINT MEDICINES CORP

AYVAKIT, AVAPRITINIB

BOEHRINGER INGELHEIM

* BOEHRINGER INGELHEIM

GILOTRIF, AFATINIB DIMALEATE

GLYXAMBI, EMPAGLIFLOZIN

MICARDIS HCT, HYDROCHLOROTHIAZIDE

MICARDIS, TELMISARTAN

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

APTIVUS, TIPRANAVIR

ATROVENT HFA, IPRATROPIUM BROMIDE

COMBIVENT RESPIMAT, ALBUTEROL SULFATE

JARDIANCE, EMPAGLIFLOZIN

JENTADUETO XR, LINAGLIPTIN

JENTADUETO, LINAGLIPTIN

MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE

MOBIC, MELOXICAM

OFEV, NINTEDANIB ESYLATE

PERSANTINE, DIPYRIDAMOLE

PRADAXA, DABIGATRAN ETEXILATE MESYLATE

SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE

SPIRIVA, TIOTROPIUM BROMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 53

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BOEHRINGER INGELHEIM PHARMACEUTICALS INC

STIOLTO RESPIMAT, OLODATEROL HYDROCHLORIDE

STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE

SYNJARDY XR, EMPAGLIFLOZIN

SYNJARDY, EMPAGLIFLOZIN

TRADJENTA, LINAGLIPTIN

TRIJARDY XR, EMPAGLIFLOZIN

VIRAMUNE XR, NEVIRAPINE

VIRAMUNE, NEVIRAPINE

BPI LABS

* BPI LABS LLC

ABLYSINOL, ALCOHOL

EPINEPHRINE, EPINEPHRINE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

ZOLEDRONIC ACID, ZOLEDRONIC ACID

BRACCO

* BRACCO DIAGNOSTICS INC

CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82

CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT

CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE

CYSTOGRAFIN, DIATRIZOATE MEGLUMINE

E-Z-HD, BARIUM SULFATE

E-Z-PAQUE, BARIUM SULFATE

ENTERO VU 24%, BARIUM SULFATE

GASTROGRAFIN, DIATRIZOATE MEGLUMINE

ISOVUE-200, IOPAMIDOL

ISOVUE-250, IOPAMIDOL

ISOVUE-300, IOPAMIDOL

ISOVUE-370, IOPAMIDOL

ISOVUE-M 200, IOPAMIDOL

ISOVUE-M 300, IOPAMIDOL

KINEVAC, SINCALIDE

LIQUID E-Z-PAQUE, BARIUM SULFATE

LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES

MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE

MULTIHANCE, GADOBENATE DIMEGLUMINE

PROHANCE MULTIPACK, GADOTERIDOL

PROHANCE, GADOTERIDOL

READI-CAT 2 SMOOTHIE, BARIUM SULFATE

READI-CAT 2, BARIUM SULFATE

TAGITOL V, BARIUM SULFATE

VARIBAR HONEY, BARIUM SULFATE

VARIBAR NECTAR, BARIUM SULFATE

VARIBAR PUDDING, BARIUM SULFATE

VARIBAR THIN HONEY, BARIUM SULFATE

VARIBAR THIN LIQUID, BARIUM SULFATE

BRAEBURN

* BRAEBURN INC

BRIXADI, BUPRENORPHINE

BRAINTREE

* BRAINTREE LABORATORIES INC

GOLYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY, POLYETHYLENE GLYCOL 3350

NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350

BRAINTREE LABS

* BRAINTREE LABORATORIES INC

SUFLAVE, MAGNESIUM SULFATE

SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE

SUTAB, MAGNESIUM SULFATE

BRECKENRIDGE

* BRECKENRIDGE PHARMACEUTICAL INC

ALPRAZOLAM, ALPRAZOLAM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 54

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

* BRECKENRIDGE PHARMACEUTICAL INC

ARIPIPRAZOLE, ARIPIPRAZOLE

ASENAPINE MALEATE, ASENAPINE MALEATE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

CLOBAZAM, CLOBAZAM

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTECAVIR, ENTECAVIR

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

EPLERENONE, EPLERENONE

EVEROLIMUS, EVEROLIMUS

EXEMESTANE, EXEMESTANE

LAMIVUDINE, LAMIVUDINE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MIGLUSTAT, MIGLUSTAT

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OMEPRAZOLE, OMEPRAZOLE

PENICILLAMINE, PENICILLAMINE

RIVASTIGMINE, RIVASTIGMINE

ROFLUMILAST, ROFLUMILAST

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

BRECKENRIDGE PHARM

* BRECKENRIDGE PHARMACEUTICAL INC

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE

OXCARBAZEPINE, OXCARBAZEPINE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

BRIGHAM WOMENS

* BRIGHAM AND WOMENS HOSP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

BRIGHAM WOMENS HOSP

* BRIGHAM AND WOMENS HOSP INC

AMMONIA N 13, AMMONIA N-13

BRIGHTGENE

* BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD

ENTECAVIR, ENTECAVIR

BRISTOL

* BRISTOL MYERS SQUIBB CO

AUGTYRO, REPOTRECTINIB

CAMZYOS, MAVACAMTEN

EVOTAZ, ATAZANAVIR SULFATE

ONUREG, AZACITIDINE

POMALYST, POMALIDOMIDE

SOTYKTU, DEUCRAVACITINIB

BRISTOL MYERS SQUIBB

* BRISTOL MYERS SQUIBB

AZACTAM, AZTREONAM

BARACLUDE, ENTECAVIR

IDHIFA, ENASIDENIB MESYLATE

REVLIMID, LENALIDOMIDE

* BRISTOL MYERS SQUIBB CO

REYATAZ, ATAZANAVIR SULFATE

SPRYCEL, DASATINIB

* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

ELIQUIS, APIXABAN

BRISTOL-MYERS

* BRISTOL-MYERS SQUIBB CO

ABRAXANE, PACLITAXEL

ISTODAX, ROMIDEPSIN

THALOMID, THALIDOMIDE

VIDAZA, AZACITIDINE

BROOKS STERISCIENCE

* BROOKS STERISCIENCE LTD

MEROPENEM, MEROPENEM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 55

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** B **

BTG INTL

* BTG INTERNATIONAL INC

CYANOKIT, HYDROXOCOBALAMIN

THYROSAFE, POTASSIUM IODIDE (OTC)

VISTOGARD, URIDINE TRIACETATE

XURIDEN, URIDINE TRIACETATE

BWXT ITG

* BWXT ITG CANADA INC

INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

** C **

CADILA

* CADILA HEALTHCARE LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

ACYCLOVIR, ACYCLOVIR

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DUTASTERIDE, DUTASTERIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FELBAMATE, FELBAMATE

FLUOCINONIDE, FLUOCINONIDE

INDOMETHACIN, INDOMETHACIN

LEVOFLOXACIN, LEVOFLOXACIN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MODAFINIL, MODAFINIL

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

PIROXICAM, PIROXICAM

RANOLAZINE, RANOLAZINE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

CADILA PHARMS LTD

* CADILA PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CELECOXIB, CELECOXIB

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

GEMFIBROZIL, GEMFIBROZIL

GLYBURIDE, GLYBURIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

NATEGLINIDE, NATEGLINIDE

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 56

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CADILA PHARMACEUTICALS LTD

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PREGABALIN, PREGABALIN

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TELMISARTAN, TELMISARTAN

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

CALL INC

* CALL INC DBA ROCHESTER PHARMACEUTICALS

ADAPALENE, ADAPALENE

CALLIDITAS

* CALLIDITAS THERAPEUTICS AB

TARPEYO, BUDESONIDE

CAPELLON PHARMS LLC

* CAPELLON PHARMACEUTICALS LLC

POLMON, DEXCHLORPHENIRAMINE MALEATE

CAPLIN

* CAPLIN STERILES LTD

ARGATROBAN, ARGATROBAN

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

ETOMIDATE, ETOMIDATE

GLYCOPYRROLATE, GLYCOPYRROLATE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OFLOXACIN, OFLOXACIN

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

CARA THERAP

* CARA THERAPEUTICS INC

KORSUVA, DIFELIKEFALIN ACETATE

CARDINAL HEALTH 414

* CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEDRONATE KIT, TECHNETIUM TC-99M MEDRONATE KIT

CARDINAL HEALTH 418

* CARDINAL HEALTH 418 INC

SODIUM IODIDE I 123, SODIUM IODIDE I-123

CARDINAL HLTH 414

* CARDINAL HEALTH 414 LLC

AMMONIA N 13, AMMONIA N-13

CARIBE HOLDINGS

* CARIBE HOLDINGS CAYMAN CO LTD DBA PURACAP CARIBE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

GEMFIBROZIL, GEMFIBROZIL

CARLSBAD
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 57

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CARLSBAD TECHNOLOGY INC

ACYCLOVIR, ACYCLOVIR

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FAMOTIDINE, FAMOTIDINE

GLIMEPIRIDE, GLIMEPIRIDE

LOVASTATIN, LOVASTATIN

CARLSBAD TECHNOLOGY

* CARLSBAD TECHNOLOGY INC

ACYCLOVIR, ACYCLOVIR

CARNEGIE

* CARNEGIE PHARMACEUTICALS LLC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

ETRAVIRINE, ETRAVIRINE

FAMOTIDINE, FAMOTIDINE

LATANOPROST, LATANOPROST

LETROZOLE, LETROZOLE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

CASI PHARMS INC

* CASI PHARMACEUTICALS INC

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

CASPER PHARMA LLC

* CASPER PHARMA LLC

ANTIVERT, MECLIZINE HYDROCHLORIDE

AQUASOL A, VITAMIN A PALMITATE

CASPORYN HC, HYDROCORTISONE

EDETATE CALCIUM DISODIUM, EDETATE CALCIUM DISODIUM

FURADANTIN, NITROFURANTOIN

LUMI-SPORYN, BACITRACIN ZINC

ROBINUL FORTE, GLYCOPYRROLATE

ROBINUL, GLYCOPYRROLATE

THALITONE, CHLORTHALIDONE

ZYLOPRIM, ALLOPURINOL

CATALENT

* CATALENT PHARMA SOLUTIONS LLC

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

VALPROIC ACID, VALPROIC ACID

CATALYST PHARMS

* CATALYST PHARMACEUTICALS INC

AGAMREE, VAMOROLONE

FIRDAPSE, AMIFAMPRIDINE PHOSPHATE

FYCOMPA, PERAMPANEL

CEDIPROF INC

* CEDIPROF INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

LEVO-T, LEVOTHYROXINE SODIUM **

CELATOR PHARMS

* CELATOR PHARMACEUTICALS INC

VYXEOS, CYTARABINE

CELGENE INTL

* CELGENE INTERNATIONAL II SARL

ZEPOSIA, OZANIMOD HYDROCHLORIDE

CELLTRION

* CELLTRION INC

LEVOFLOXACIN, LEVOFLOXACIN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

CEPHALON

* CEPHALON INC

GABITRIL, TIAGABINE HYDROCHLORIDE

NUVIGIL, ARMODAFINIL

TREANDA, BENDAMUSTINE HYDROCHLORIDE

TRISENOX, ARSENIC TRIOXIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 58

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CEPHALON LLC

ACTIQ, FENTANYL CITRATE

FENTORA, FENTANYL CITRATE

PROVIGIL, MODAFINIL

CEROVENE INC

* CEROVENE INC

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

PYRIMETHAMINE, PYRIMETHAMINE

SEROMYCIN, CYCLOSERINE

CHANGZHOU PHARM

* CHANGZHOU PHARMACEUTICAL FACTORY

CAPTOPRIL, CAPTOPRIL

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

PREGABALIN, PREGABALIN

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

CHARTWELL

* CHARTWELL LIFE MOLECULES LLC

ALLOPURINOL, ALLOPURINOL

AMOXICILLIN, AMOXICILLIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CIPROFLOXACIN, CIPROFLOXACIN

CLARITHROMYCIN, CLARITHROMYCIN

COLOCORT, HYDROCORTISONE

FLUCONAZOLE, FLUCONAZOLE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OXAPROZIN, OXAPROZIN

TEMOZOLOMIDE, TEMOZOLOMIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

* CHARTWELL PHARMA SCIENCE LLC

SULFASALAZINE, SULFASALAZINE

* CHARTWELL SCHEDULED LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

CHARTWELL INJECTABLE

* CHARTWELL INJECTABLES LLC

DIPYRIDAMOLE, DIPYRIDAMOLE

DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

TERBUTALINE SULFATE, TERBUTALINE SULFATE

CHARTWELL MOLECULAR

* CHARTWELL MOLECULAR HOLDINGS LLC

ACETAZOLAMIDE, ACETAZOLAMIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CALCIUM ACETATE, CALCIUM ACETATE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXAMETHASONE, DEXAMETHASONE

DIAZEPAM, DIAZEPAM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FOLIC ACID, FOLIC ACID
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 59

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CHARTWELL MOLECULAR HOLDINGS LLC

GLIMEPIRIDE, GLIMEPIRIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRBESARTAN, IRBESARTAN

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LAMIVUDINE, LAMIVUDINE

LANSOPRAZOLE, LANSOPRAZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

OLANZAPINE, OLANZAPINE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

RAMIPRIL, RAMIPRIL

RIFAMPIN, RIFAMPIN

RISPERIDONE, RISPERIDONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

THEOPHYLLINE, THEOPHYLLINE

ZALEPLON, ZALEPLON

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

CHARTWELL MOLECULES

* CHARTWELL MOLECULES LLC

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DISULFIRAM, DISULFIRAM

GEMFIBROZIL, GEMFIBROZIL

INDOMETHACIN, INDOMETHACIN

NABUMETONE, NABUMETONE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

CHARTWELL RX

* CHARTWELL RX SCIENCES LLC

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

ATOVAQUONE, ATOVAQUONE

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE

CALCIPOTRIENE, CALCIPOTRIENE

CALCIUM ACETATE, CALCIUM ACETATE

CARBAMAZEPINE, CARBAMAZEPINE

CARISOPRODOL, CARISOPRODOL

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORTHALIDONE, CHLORTHALIDONE

CICLOPIROX, CICLOPIROX

CILOSTAZOL, CILOSTAZOL

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 60

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CHARTWELL RX SCIENCES LLC

DEFERASIROX, DEFERASIROX

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DUVOID, BETHANECHOL CHLORIDE

EPLERENONE, EPLERENONE

ERGOCALCIFEROL, ERGOCALCIFEROL

ETHACRYNIC ACID, ETHACRYNIC ACID

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE, FENOFIBRATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FULVICIN P/G 165, GRISEOFULVIN, ULTRAMICROCRYSTALLINE

FULVICIN P/G 330, GRISEOFULVIN, ULTRAMICROCRYSTALLINE

FULVICIN P/G, GRISEOFULVIN, ULTRAMICROCRYSTALLINE

FULVICIN-U/F, GRISEOFULVIN, MICROCRYSTALLINE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HALCINONIDE, HALCINONIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

INDOMETHACIN, INDOMETHACIN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LACTULOSE, LACTULOSE

LEVETIRACETAM, LEVETIRACETAM

LINEZOLID, LINEZOLID

LISINOPRIL, LISINOPRIL

LOCHOLEST LIGHT, CHOLESTYRAMINE

LOCHOLEST, CHOLESTYRAMINE

LOVASTATIN, LOVASTATIN

METHIMAZOLE, METHIMAZOLE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METRONIDAZOLE, METRONIDAZOLE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MONODOX, DOXYCYCLINE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

OXCARBAZEPINE, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PREGABALIN, PREGABALIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RASAGILINE MESYLATE, RASAGILINE MESYLATE

REPAGLINIDE, REPAGLINIDE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

RUFINAMIDE, RUFINAMIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 61

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CHARTWELL RX SCIENCES LLC

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TADALAFIL, TADALAFIL

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TAVABOROLE, TAVABOROLE

TELMISARTAN, TELMISARTAN

TETRABENAZINE, TETRABENAZINE

TINIDAZOLE, TINIDAZOLE

TOBRAMYCIN, TOBRAMYCIN

TRAVOPROST, TRAVOPROST

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

URSODIOL, URSODIOL

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

VORICONAZOLE, VORICONAZOLE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

CHARTWELL TETRA

* CHARTWELL TETRA LLC

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

CHATTEM

* CHATTEM INC

UNISOM, DOXYLAMINE SUCCINATE (OTC)

CHATTEM SANOFI

* CHATTEM INC DBA SANOFI CONSUMER HEALTHCARE

ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)

ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC)

NICODERM CQ, NICOTINE (OTC)

XYZAL ALLERGY 24HR, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

CHEMI SPA

* CHEMI SPA

DECITABINE, DECITABINE

TEMOZOLOMIDE, TEMOZOLOMIDE

CHEMISCH FBRK KRSSLR

* CHEMISCHE FABRIK KREUSSLER & CO. GMBH

ASCLERA, POLIDOCANOL

CHEMISTRY HLTH

* CHEMISTRY AND HEALTH FZ LLC

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

CHEMO RESEARCH SL

* CHEMO RESEARCH SL

BENZNIDAZOLE, BENZNIDAZOLE

ESTRADIOL, ESTRADIOL

NUVESSA, METRONIDAZOLE

CHEMOCENTRYX

* CHEMOCENTRYX INC

TAVNEOS, AVACOPAN

CHENGDU SHUODE

* CHENGDU SHUODE PHARMACEUTICAL CO LTD

NALMEFENE HYDROCHLORIDE, NALMEFENE HYDROCHLORIDE

CHEPLAPHARM

* CHEPLAPHARM ARZNEIMITTEL GMBH

DROXIA, HYDROXYUREA

ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE

HYDREA, HYDROXYUREA

KLONOPIN, CLONAZEPAM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 62

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CHEPLAPHARM ARZNEIMITTEL GMBH

VALCYTE, VALGANCICLOVIR HYDROCHLORIDE

XELODA, CAPECITABINE

XENICAL, ORLISTAT

* CHEPLAPHARM REGISTRATION GMBH

ZYPREXA RELPREVV, OLANZAPINE PAMOATE

ZYPREXA ZYDIS, OLANZAPINE

ZYPREXA, OLANZAPINE

CHIA TAI TIANQING

* CHIA TAI TIANQING PHARMACEUTICAL GROUP CO LTD

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FULVESTRANT, FULVESTRANT

CHIESI

* CHIESI FARMACEUTICI SPA

MYCAPSSA, OCTREOTIDE ACETATE

* CHIESI USA INC

BETHKIS, TOBRAMYCIN

BRONCHITOL, MANNITOL

CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE

CLEVIPREX, CLEVIDIPINE

FERRIPROX, DEFERIPRONE

KENGREAL, CANGRELOR

ZYFLO, ZILEUTON

CHILDRENS HOSP MI

* CHILDRENS HOSP MICHIGAN

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

CHINA RESOURCES

* CHINA RESOURCES SAIKE PHARMACEUTICAL CO LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CHIRHOCLIN

* CHIRHOCLIN INC

CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN

CIDARA THERAPS

* CIDARA THERAPEUTICS INC

REZZAYO, REZAFUNGIN ACETATE

CINTEX SVCS

* CINTEX SERVICES LLC

DESONIDE, DESONIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

CIPHER PHARMS INC

* CIPHER PHARMACEUTICALS INC

CONZIP, TRAMADOL HYDROCHLORIDE

LIPOFEN, FENOFIBRATE

CIPLA

* CIPLA LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, ABACAVIR SULFATE

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

AMBRISENTAN, AMBRISENTAN

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ANASTROZOLE, ANASTROZOLE

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

AZACITIDINE, AZACITIDINE

BUDESONIDE, BUDESONIDE

CELECOXIB, CELECOXIB

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DARUNAVIR, DARUNAVIR

DEFERASIROX, DEFERASIROX
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 63

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CIPLA LTD

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLUPREDNATE, DIFLUPREDNATE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

EFAVIRENZ, EFAVIRENZ

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

EMTRICITABINE, EMTRICITABINE

ENTECAVIR, ENTECAVIR

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

EXEMESTANE, EXEMESTANE

FENOFIBRATE, FENOFIBRATE

FINASTERIDE, FINASTERIDE

FOSFOMYCIN TROMETHAMINE, FOSFOMYCIN TROMETHAMINE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

ICATIBANT ACETATE, ICATIBANT ACETATE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LENALIDOMIDE, LENALIDOMIDE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

MELOXICAM, MELOXICAM

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NEVIRAPINE, NEVIRAPINE

PHYTONADIONE, PHYTONADIONE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREGABALIN, PREGABALIN

RITONAVIR, RITONAVIR

SUMATRIPTAN, SUMATRIPTAN

TADALAFIL, TADALAFIL

TAVABOROLE, TAVABOROLE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE, TESTOSTERONE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VASOPRESSIN, VASOPRESSIN

ZIDOVUDINE, ZIDOVUDINE

CIPLA LTD

* CIPLA LTD

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

ZIDOVUDINE, ZIDOVUDINE

CIPLA USA

* CIPLA USA INC

ZEMDRI, PLAZOMICIN SULFATE

CISEN

* CISEN PHARMACEUTICAL CO LTD

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

CLINIGEN

* CLINIGEN INC

ETHYOL, AMIFOSTINE

CLINIGEN HLTHCARE

* CLINIGEN HEALTHCARE LTD

FOSCAVIR, FOSCARNET SODIUM

CLIVUNEL INC

* CLINUVEL INC

SCENESSE, AFAMELANOTIDE

CMP DEV LLC

* CMP DEVELOPMENT LLC

ATORVALIQ, ATORVASTATIN CALCIUM

CAROSPIR, SPIRONOLACTONE

LIQREV, SILDENAFIL CITRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 64

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* CMP DEVELOPMENT LLC

NORLIQVA, AMLODIPINE BESYLATE

POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC

TADLIQ, TADALAFIL

CMP PHARMA INC

* CMP PHARMA INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE

ISONIAZID, ISONIAZID

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SPS, SODIUM POLYSTYRENE SULFONATE

COLGATE-PALMOLIVE CO

* COLGATE-PALMOLIVE CO

PERIOGARD, CHLORHEXIDINE GLUCONATE

COLLEGIUM PHARM INC

* COLLEGIUM PHARMACEUTICAL INC

NUCYNTA ER, TAPENTADOL HYDROCHLORIDE

NUCYNTA, TAPENTADOL HYDROCHLORIDE

XTAMPZA ER, OXYCODONE

COMBE

* COMBE INC

VAGISTAT-1, TIOCONAZOLE (OTC)

COMMAVE THERAP

* COMMAVE THERAPEUTICS SA

AZSTARYS, DEXMETHYLPHENIDATE HYDROCHLORIDE

CONCORD BIOTECH LTD

* CONCORD BIOTECH LTD

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

TACROLIMUS, TACROLIMUS

CONCORDIA

* CONCORDIA PHARMACEUTICALS INC

DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE

DYRENIUM, TRIAMTERENE

LANOXIN, DIGOXIN

NILANDRON, NILUTAMIDE

PANRETIN, ALITRETINOIN

PARNATE, TRANYLCYPROMINE SULFATE

PLAQUENIL, HYDROXYCHLOROQUINE SULFATE

SALAGEN, PILOCARPINE HYDROCHLORIDE

UROXATRAL, ALFUZOSIN HYDROCHLORIDE

ZONEGRAN, ZONISAMIDE

CONCORDIA PHARMS INC

* CONCORDIA PHARMACEUTICALS INC

ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE

CONTRACT PHARMACAL

* CONTRACT PHARMACAL CORP

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

FAMOTIDINE, FAMOTIDINE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

COOPERSURGICAL

* COOPERSURGICAL INC

PARAGARD T 380A, COPPER

CORCEPT THERAP

* CORCEPT THERAPEUTICS INC

KORLYM, MIFEPRISTONE

CORDEN PHARMA

* CORDEN PHARMA LATINA SPA

GLEOSTINE, LOMUSTINE

COREPHARMA

* COREPHARMA LLC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 65

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* COREPHARMA LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

CAPTOPRIL, CAPTOPRIL

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

LISINOPRIL, LISINOPRIL

LOVASTATIN, LOVASTATIN

MELOXICAM, MELOXICAM

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TORSEMIDE, TORSEMIDE

CORIUM

* CORIUM INC

ADLARITY, DONEPEZIL HYDROCHLORIDE

CORMEDIX

* CORMEDIX INC

DEFENCATH, HEPARIN SODIUM

COSETTE

* COSETTE PHARMACEUTICALS INC

ACEPHEN, ACETAMINOPHEN (OTC)

ACYCLOVIR, ACYCLOVIR

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AZOR, AMLODIPINE BESYLATE

BENICAR HCT, HYDROCHLOROTHIAZIDE

BENICAR, OLMESARTAN MEDOXOMIL

BETA-VAL, BETAMETHASONE VALERATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOMIPHENE CITRATE, CLOMIPHENE CITRATE

DAPSONE, DAPSONE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

DOXYCYCLINE, DOXYCYCLINE

EFFIENT, PRASUGREL HYDROCHLORIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

EVOXAC, CEVIMELINE HYDROCHLORIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

INDOMETHACIN, INDOMETHACIN

LIDOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MIGERGOT, CAFFEINE

MOMETASONE FUROATE, MOMETASONE FUROATE

MYKACET, NYSTATIN

NYSTATIN, NYSTATIN

PROCHLORPERAZINE, PROCHLORPERAZINE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 66

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

* COSETTE PHARMACEUTICALS INC

TAZAROTENE, TAZAROTENE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIBENZOR, AMLODIPINE BESYLATE

WELCHOL, COLESEVELAM HYDROCHLORIDE

COVIS

* COVIS PHARMA GMBH

ALTOPREV, LOVASTATIN

ALVESCO, CICLESONIDE

DUAKLIR PRESSAIR, ACLIDINIUM BROMIDE

FERAHEME, FERUMOXYTOL

LANOXIN PEDIATRIC, DIGOXIN

LANOXIN, DIGOXIN

OMNARIS, CICLESONIDE

PRILOSEC, OMEPRAZOLE MAGNESIUM

RILUTEK, RILUZOLE

SULAR, NISOLDIPINE

TUDORZA PRESSAIR, ACLIDINIUM BROMIDE

ZETONNA, CICLESONIDE

CPPI CV

* CP PHARMACEUTICALS INTERNATIONAL CV

SUTENT, SUNITINIB MALATE

CREEKWOOD PHARMS

* CREEKWOOD PHARMACEUTICALS LLC

FENOFIBRATE, FENOFIBRATE

PREGABALIN, PREGABALIN

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SILODOSIN, SILODOSIN

CROSSMEDIKA SA

* CROSSMEDIKA SA

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

CROWN LABS

* CROWN LABORATORIES INC

ALA-CORT, HYDROCORTISONE

TRIDERM, TRIAMCINOLONE ACETONIDE

CROWN LABS INC

* CROWN LABORATORIES INC

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

CSPC OUYI

* CSPC OUYI PHARMACEUTICAL CO LTD

AZITHROMYCIN, AZITHROMYCIN

CARBAMAZEPINE, CARBAMAZEPINE

CELECOXIB, CELECOXIB

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

GABAPENTIN, GABAPENTIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PALIPERIDONE, PALIPERIDONE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

CSPC OUYI PHARM CO

* CSPC OUYI PHARMACEUTICAL CO LTD

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

CSPC-NBP PHARM

* CSPC-NBP PHARMACEUTICAL CO LTD

BENZONATATE, BENZONATATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

CTI BIOPHARMA CORP

* CTI BIOPHARMA CORP

VONJO, PACRITINIB CITRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 67

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** C **

CUBIST PHARMS LLC

* CUBIST PHARMACEUTICALS LLC

DIFICID, FIDAXOMICIN

SIVEXTRO, TEDIZOLID PHOSPHATE

ZERBAXA, CEFTOLOZANE SULFATE

CUMBERLAND

* CUMBERLAND PHARMACEUTICALS INC

SANCUSO, GRANISETRON

VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE

VIBATIV, TELAVANCIN HYDROCHLORIDE

CUMBERLAND PHARMS

* CUMBERLAND PHARMACEUTICALS INC

ACETADOTE, ACETYLCYSTEINE

CALDOLOR, IBUPROFEN

LACTULOSE, LACTULOSE

CURIUM

* CURIUM US LLC

GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67

INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE

IOFLUPANE I-123, IOFLUPANE I-123

OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT

SODIUM IODIDE I 123, SODIUM IODIDE I-123

TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT

TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT

TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201

ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT

XENON XE 133, XENON XE-133

CURRAX

* CURRAX PHARMACEUTICALS LLC

ONZETRA XSAIL, SUMATRIPTAN SUCCINATE

SILENOR, DOXEPIN HYDROCHLORIDE

TREXIMET, NAPROXEN SODIUM

CUSTOPHARM INC

* CUSTOPHARM INC

CALCITONIN-SALMON, CALCITONIN SALMON

CYCLE

* CYCLE PHARMACEUTICALS LTD

NITYR, NITISINONE

TASCENSO ODT, FINGOLIMOD LAURYL SULFATE

CYCLOMEDICA

* CYCLOMEDICA AUSTRALIA PTY LTD

TECHNEGAS KIT, TECHNETIUM TC-99M LABELED CARBON

** D **

DAEWOONG PHARM CO

* DAEWOONG PHARMACEUTICAL CO LTD

MEROPENEM, MEROPENEM

DAIICHI SANKYO INC

* DAIICHI SANKYO INC

SAVAYSA, EDOXABAN TOSYLATE

TURALIO, PEXIDARTINIB HYDROCHLORIDE

VANFLYTA, QUIZARTINIB DIHYDROCHLORIDE

DAITO

* DAITO PHARMACEUTICAL CO LTD

METHOTREXATE SODIUM, METHOTREXATE SODIUM

DANCO LABS LLC

* DANCO LABORATORIES LLC

MIFEPREX, MIFEPRISTONE

DARE

* DARE BIOSCIENCE INC

XACIATO, CLINDAMYCIN PHOSPHATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 68

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

DASH PHARMS

* DASH PHARMACEUTICALS LLC

TESTOSTERONE, TESTOSTERONE

DASH PHARMS NATCO

* DASH PHARMACEUTICALS LLC A FULLY OWNED SUB OF NATCO PHARMA LTD

ALBUTEROL SULFATE, ALBUTEROL SULFATE

DAVA PHARMS INC

* DAVA PHARMACEUTICALS INC

AMOXICILLIN, AMOXICILLIN

MORPHINE SULFATE, MORPHINE SULFATE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

DAVIS AND GECK

* DAVIS AND GECK DIV AMERICAN CYANAMID CO

PRE-OP II, HEXACHLOROPHENE

PRE-OP, HEXACHLOROPHENE

DECATUR

* DECATUR MEMORIAL HOSP

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

DECIPHERA PHARMS

* DECIPHERA PHARMACEUTICALS LLC

QINLOCK, RIPRETINIB

DELCATH SYSTEMS INC

* DELCATH SYSTEMS INC

HEPZATO, MELPHALAN HYDROCHLORIDE

DENTSPLY PHARM

* DENTSPLY PHARMACEUTICAL INC

CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE

ORAQIX, LIDOCAINE

DEPROCO

* DEPROCO INC

LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE

LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE

SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE

SEPTOCAINE, ARTICAINE HYDROCHLORIDE

DERMAVANT SCI

* DERMAVANT SCIENCES INC

VTAMA, TAPINAROF

DEVA HOLDING AS

* DEVA HOLDING AS

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TEMOZOLOMIDE, TEMOZOLOMIDE

DEXCEL

* DEXCEL PHARMA TECHNOLOGIES LTD

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

HEMADY, DEXAMETHASONE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

OMEPRAZOLE, OMEPRAZOLE (OTC)

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VIGABATRIN, VIGABATRIN

DEXCEL LTD

* DEXCEL LTD

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

DEXCEL PHARMA

* DEXCEL PHARMA TECHNOLOGIES LTD

OMEPRAZOLE, OMEPRAZOLE (OTC)

DIALYSIS SUPS

* DIALYSIS SUPPLIES INC

NORMOCARB HF 25, MAGNESIUM CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 69

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DIALYSIS SUPPLIES INC

NORMOCARB HF 35, MAGNESIUM CHLORIDE

DORC

* DORC INTERNATIONAL BV

VISIONBLUE, TRYPAN BLUE

DOW PHARM

* DOW PHARMACEUTICAL SCIENCES

ALTRENO, TRETINOIN

ATRALIN, TRETINOIN

DR REDDYS

* DR REDDYS LABORATORIES INC

FENOFIBRATE, FENOFIBRATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

ICOSAPENT ETHYL, ICOSAPENT ETHYL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NITROGLYCERIN, NITROGLYCERIN

PROGESTERONE, PROGESTERONE

PROPOFOL, PROPOFOL

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

* DR REDDYS LABORATORIES LTD

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ALBENDAZOLE, ALBENDAZOLE

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZACITIDINE, AZACITIDINE

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BIVALIRUDIN, BIVALIRUDIN

BORTEZOMIB, BORTEZOMIB

CABAZITAXEL, CABAZITAXEL

CAPECITABINE, CAPECITABINE

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CARFILZOMIB, CARFILZOMIB

CARMUSTINE, CARMUSTINE

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CIPROFLOXACIN AND DEXAMETHASONE, CIPROFLOXACIN

CLOFARABINE, CLOFARABINE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

COLCHICINE, COLCHICINE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DAPTOMYCIN, DAPTOMYCIN

DARUNAVIR, DARUNAVIR

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIFLUPREDNATE, DIFLUPREDNATE

DOCETAXEL, DOCETAXEL

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

EPHEDRINE SULFATE, EPHEDRINE SULFATE

ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

ESZOPICLONE, ESZOPICLONE

FEBUXOSTAT, FEBUXOSTAT

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FULVESTRANT, FULVESTRANT
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 70

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES LTD

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

IMATINIB MESYLATE, IMATINIB MESYLATE

LANSOPRAZOLE, LANSOPRAZOLE

LENALIDOMIDE, LENALIDOMIDE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

LIDOCAINE, LIDOCAINE

LUBIPROSTONE, LUBIPROSTONE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

NELARABINE, NELARABINE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OMEPRAZOLE, OMEPRAZOLE (OTC)

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PARICALCITOL, PARICALCITOL

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PENICILLAMINE, PENICILLAMINE

PHYTONADIONE, PHYTONADIONE

PLERIXAFOR, PLERIXAFOR

POSACONAZOLE, POSACONAZOLE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PREGABALIN, PREGABALIN

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

REGADENOSON, REGADENOSON

SAPROPTERIN DIHYDROCHLORIDE, SAPROPTERIN DIHYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SIROLIMUS, SIROLIMUS

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SORAFENIB TOSYLATE, SORAFENIB TOSYLATE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUNITINIB MALATE, SUNITINIB MALATE

TADALAFIL, TADALAFIL

TETRABENAZINE, TETRABENAZINE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

THIOTEPA, THIOTEPA

TIMOLOL MALEATE, TIMOLOL MALEATE

TOPIRAMATE, TOPIRAMATE

TREPROSTINIL, TREPROSTINIL

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

VIGABATRIN, VIGABATRIN

VINORELBINE TARTRATE, VINORELBINE TARTRATE

DR REDDYS LA

* DR REDDYS LABORATORIES LOUISIANA LLC

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LOPURIN, ALLOPURINOL

SSD, SILVER SULFADIAZINE

DR REDDYS LABS EU

* DR REDDYS LABORATORIES EU LTD

PERMETHRIN, PERMETHRIN

DR REDDYS LABS INC

* DR REDDYS LABORATORIES INC

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 71

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES INC

FINASTERIDE, FINASTERIDE

FLUCONAZOLE, FLUCONAZOLE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LEVOFLOXACIN, LEVOFLOXACIN

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SIMVASTATIN, SIMVASTATIN

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

DR REDDYS LABS LTD

* DR REDDYS LABORATORIES LIMITED

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

* DR REDDYS LABORATORIES LTD

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

FAMOTIDINE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE (OTC)

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LEVETIRACETAM, LEVETIRACETAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NAPROXEN SODIUM, NAPROXEN SODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 72

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES LTD

NATEGLINIDE, NATEGLINIDE

NIZATIDINE, NIZATIDINE

OFLOXACIN, OFLOXACIN

OLANZAPINE, OLANZAPINE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXAPROZIN, OXAPROZIN

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RAMIPRIL, RAMIPRIL

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

RISPERIDONE, RISPERIDONE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

TACROLIMUS, TACROLIMUS

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZAFIRLUKAST, ZAFIRLUKAST

ZENATANE, ISOTRETINOIN

ZOLEDRONIC ACID, ZOLEDRONIC ACID

DR REDDYS LABS SA

* DR REDDYS LABORATORIES SA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BIORPHEN, PHENYLEPHRINE HYDROCHLORIDE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

BUDESONIDE, BUDESONIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CAMILA, NORETHINDRONE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CHLORZOXAZONE, CHLORZOXAZONE

CLARITHROMYCIN, CLARITHROMYCIN

CLONIDINE, CLONIDINE

CYCLOSPORINE, CYCLOSPORINE

DIAZEPAM, DIAZEPAM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DOFETILIDE, DOFETILIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ERRIN, NORETHINDRONE

ERYC, ERYTHROMYCIN

ESTAZOLAM, ESTAZOLAM

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FLUOROURACIL, FLUOROURACIL

HABITROL, NICOTINE (OTC)

HALOETTE, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVORA 0.15/30-28, ETHINYL ESTRADIOL

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LOW-OGESTREL-28, ETHINYL ESTRADIOL

MERCAPTOPURINE, MERCAPTOPURINE

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

RAMELTEON, RAMELTEON
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 73

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** D **

* DR REDDYS LABORATORIES SA

REZIPRES, EPHEDRINE HYDROCHLORIDE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TOBRAMYCIN, TOBRAMYCIN

TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL

TRIMETHOPRIM, TRIMETHOPRIM

TRIVORA-28, ETHINYL ESTRADIOL

DUCHESNAY

* DUCHESNAY INC

BONJESTA, DOXYLAMINE SUCCINATE

DICLEGIS, DOXYLAMINE SUCCINATE

OSPHENA, OSPEMIFENE

DURAMED PHARMS BARR

* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC

AVIANE-28, ETHINYL ESTRADIOL

CRYSELLE, ETHINYL ESTRADIOL

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

ENPRESSE-28, ETHINYL ESTRADIOL

VELIVET, DESOGESTREL

DUSA

* DUSA PHARMACEUTICALS INC

LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE

DUTCH OPHTHALMIC

* DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV

TISSUEBLUE, BRILLIANT BLUE G

REDDYS

* DOCTOR REDDYS LABORATORIES LTD

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

** E **

E5 PHARMA INC

* E5 PHARMA INC

DIAZOXIDE, DIAZOXIDE

EAGLE PHARMS

* EAGLE PHARMACEUTICALS INC

BELRAPZO, BENDAMUSTINE HYDROCHLORIDE

BENDEKA, BENDAMUSTINE HYDROCHLORIDE

PEMFEXY, PEMETREXED

RYANODEX, DANTROLENE SODIUM

VASOPRESSIN, VASOPRESSIN

ECI PHARMS LLC

* ECI PHARMACEUTICALS LLC

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

ECOLAB

* ECOLAB INC

CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)

CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)

EDENBRIDGE PHARMS

* EDENBRIDGE PHARMACEUTICALS LLC

ALBENDAZOLE, ALBENDAZOLE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

CARBIDOPA, CARBIDOPA

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ETHACRYNIC ACID, ETHACRYNIC ACID

IVERMECTIN, IVERMECTIN

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TINIDAZOLE, TINIDAZOLE

YARGESA, MIGLUSTAT

EDISON THERAPS LLC

* EDISON THERAPEUTICS LLC

METHERGINE, METHYLERGONOVINE MALEATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 74

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

EIGER BIOPHARMS

* EIGER BIOPHARMACEUTICALS INC

ZOKINVY, LONAFARNIB

EIRGEN

* EIRGEN PHARMA LTD

RAYALDEE, CALCIFEDIOL

EISAI INC

* EISAI INC

ARICEPT, DONEPEZIL HYDROCHLORIDE

BANZEL, RUFINAMIDE

DAYVIGO, LEMBOREXANT

HALAVEN, ERIBULIN MESYLATE

LENVIMA, LENVATINIB MESYLATE

ELI LILLY AND CO

* ELI LILLY AND CO

MOUNJARO, TIRZEPATIDE

OLUMIANT, BARICITINIB

PROZAC, FLUOXETINE HYDROCHLORIDE

REYVOW, LASMIDITAN SUCCINATE

VERZENIO, ABEMACICLIB

ZEPBOUND, TIRZEPATIDE

ELI LILLY CO

* ELI LILLY CO

ADCIRCA, TADALAFIL

ELITE LABS

* ELITE LABORATORIES INC

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

ELITE LABS INC

* ELITE LABORATORIES INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

DANTROLENE SODIUM, DANTROLENE SODIUM

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

ISRADIPINE, ISRADIPINE

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE

ELITE PHARM SOLUTION

* ELITE PHARMACEUTICAL SOLUTION INC

NIFEDIPINE, NIFEDIPINE

ELYSIUM

* ELYSIUM PHARMACEUTICALS LTD

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

EMD SERONO INC

* EMD SERONO INC

CETROTIDE, CETRORELIX ACETATE

MAVENCLAD, CLADRIBINE

TEPMETKO, TEPOTINIB HYDROCHLORIDE

EMED MEDCL

* EMED MEDICAL CO LLC

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

EMERGENT

* EMERGENT OPERATIONS IRELAND LTD

NARCAN, NALOXONE HYDROCHLORIDE (OTC)

EMERGENT BIODEFENSE

* EMERGENT BIODEFENSE OPERATIONS LANSING INC

TEMBEXA, BRINCIDOFOVIR

* EMERGENT BIODEFENSE OPERATIONS LANSING LLC

TEMBEXA, BRINCIDOFOVIR

EMMAUS MEDCL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 75

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EMMAUS MEDICAL INC

ENDARI, L-GLUTAMINE

ENCUBE

* ENCUBE ETHICALS PRIVATE LTD

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

AZELAIC ACID, AZELAIC ACID

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DAPSONE, DAPSONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC)

DOCOSANOL, DOCOSANOL (OTC)

FLUOROURACIL, FLUOROURACIL

KETOCONAZOLE, KETOCONAZOLE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

MESALAMINE, MESALAMINE

METRONIDAZOLE, METRONIDAZOLE

MUPIROCIN, MUPIROCIN CALCIUM

TACROLIMUS, TACROLIMUS

TAVABOROLE, TAVABOROLE

TESTOSTERONE, TESTOSTERONE

TRETINOIN MICROSPHERE, TRETINOIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

ENCUBE ETHICALS

* ENCUBE ETHICALS PVT LTD

ADAPALENE, ADAPALENE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DESONIDE, DESONIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

PERMETHRIN, PERMETHRIN

ENDO PHARM

* ENDO PHARMACEUTICAL SOLUTIONS INC

SUPPRELIN LA, HISTRELIN ACETATE

VALSTAR PRESERVATIVE FREE, VALRUBICIN

ENDO PHARMS

* ENDO PHARMACEUTICALS INC

FORTESTA, TESTOSTERONE

FROVA, FROVATRIPTAN SUCCINATE

PERCODAN, ASPIRIN

ENDO PHARMS INC

* ENDO PHARMACEUTICALS INC

AVEED, TESTOSTERONE UNDECANOATE

COLY-MYCIN S, COLISTIN SULFATE

MEGACE ES, MEGESTROL ACETATE

NASCOBAL, CYANOCOBALAMIN

ENTASIS THERAP

* ENTASIS THERAPEUTICS INC

XACDURO (COPACKAGED), DURLOBACTAM SODIUM

EPI HLTH

* EPI HEALTH LLC

CLODERM, CLOCORTOLONE PIVALATE

MINOLIRA, MINOCYCLINE HYDROCHLORIDE

EPIC PHARMA

* EPIC PHARMA LLC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

SULINDAC, SULINDAC

TRANDOLAPRIL, TRANDOLAPRIL

URSODIOL, URSODIOL

EPIC PHARMA LLC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 76

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EPIC PHARMA LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CILOSTAZOL, CILOSTAZOL

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE

DESOXIMETASONE, DESOXIMETASONE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERYTHROMYCIN, ERYTHROMYCIN

ESTRADIOL, ESTRADIOL

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

FUROSEMIDE, FUROSEMIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE, GLYBURIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LOVASTATIN, LOVASTATIN

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

MOLINDONE HYDROCHLORIDE, MOLINDONE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NIZATIDINE, NIZATIDINE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXAZEPAM, OXAZEPAM

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE AND ASPIRIN, ASPIRIN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PHENYTOIN, PHENYTOIN

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREGABALIN, PREGABALIN

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

QUINIDINE SULFATE, QUINIDINE SULFATE

RIFAMPIN, RIFAMPIN

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SULFADIAZINE, SULFADIAZINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TROPICACYL, TROPICAMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 77

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EPIC PHARMA LLC

VORICONAZOLE, VORICONAZOLE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

EPIZYME INC

* EPIZYME INC

TAZVERIK, TAZEMETOSTAT HYDROBROMIDE

ESKAYEF

* ESKAYEF PHARMACEUTICALS LTD

PREGABALIN, PREGABALIN

ESPERION THERAPS INC

* ESPERION THERAPEUTICS INC

NEXLETOL, BEMPEDOIC ACID

NEXLIZET, BEMPEDOIC ACID

ESSENTIAL ISOTOPES

* ESSENTIAL ISOTOPES LLC

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

ETHYPHARM

* ETHYPHARM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

* ETHYPHARM SA

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ETHYPHARM USA CORP

* ETHYPHARM USA CORP

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

ETON

* ETON PHARMACEUTICALS INC

ALKINDI SPRINKLE, HYDROCORTISONE

BETAINE, BETAINE

NITISINONE, NITISINONE

EUGIA PHARMA

* EUGIA PHARMA SPECIALITIES LTD

ACETAMINOPHEN, ACETAMINOPHEN

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

AMPHOTERICIN B, AMPHOTERICIN B

ANASTROZOLE, ANASTROZOLE

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZACITIDINE, AZACITIDINE

AZITHROMYCIN, AZITHROMYCIN

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BIMATOPROST, BIMATOPROST

BIVALIRUDIN, BIVALIRUDIN

BORTEZOMIB, BORTEZOMIB

BROMFENAC SODIUM, BROMFENAC SODIUM

BUDESONIDE, BUDESONIDE

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CAPECITABINE, CAPECITABINE

CARBOPLATIN, CARBOPLATIN

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CYANOCOBALAMIN, CYANOCOBALAMIN

DACTINOMYCIN, DACTINOMYCIN

DAPTOMYCIN, DAPTOMYCIN

DECITABINE, DECITABINE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 78

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EUGIA PHARMA SPECIALITIES LTD

DOCETAXEL, DOCETAXEL

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EPTIFIBATIDE, EPTIFIBATIDE

ERTAPENEM SODIUM, ERTAPENEM SODIUM

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ETOMIDATE, ETOMIDATE

EXEMESTANE, EXEMESTANE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FULVESTRANT, FULVESTRANT

FUROSEMIDE, FUROSEMIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

ICATIBANT ACETATE, ICATIBANT ACETATE

IMATINIB MESYLATE, IMATINIB MESYLATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

LENALIDOMIDE, LENALIDOMIDE

LETROZOLE, LETROZOLE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIFITEGRAST, LIFITEGRAST

LINEZOLID, LINEZOLID

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MEROPENEM, MEROPENEM

METHOCARBAMOL, METHOCARBAMOL

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC)

OXALIPLATIN, OXALIPLATIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PLERIXAFOR, PLERIXAFOR

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POSACONAZOLE, POSACONAZOLE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROGESTERONE, PROGESTERONE

REGADENOSON, REGADENOSON

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 79

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EUGIA PHARMA SPECIALITIES LTD

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TIGECYCLINE, TIGECYCLINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TIROFIBAN HYDROCHLORIDE, TIROFIBAN HYDROCHLORIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TRANEXAMIC ACID, TRANEXAMIC ACID

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VASOPRESSIN, VASOPRESSIN

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

EUGIA PHARMA SPECLTS

* EUGIA PHARMA SPECIALITIES LTD

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

OXACILLIN SODIUM, OXACILLIN SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

EUROCEPT PHARMS

* EUROCEPT PHARMACEUTICALS

PASER, AMINOSALICYLIC ACID

EUROHLTH INTL SARL

* EUROHEALTH INTERNATIONAL SARL

AZACITIDINE, AZACITIDINE

EVEREST LIFE SCI

* EVEREST LIFE SCIENCES LLC

DAPSONE, DAPSONE

EVOFEM INC

* EVOFEM INC

PHEXXI, CITRIC ACID

EVOKE PHARMA INC

* EVOKE PHARMA INC

GIMOTI, METOCLOPRAMIDE HYDROCHLORIDE

EVUS

* EVUS HEALTH SOLUTIONS LLC

NITROMIST, NITROGLYCERIN

EXELA PHARMA

* EXELA PHARMA SCIENCES LLC

ACETYLCYSTEINE, ACETYLCYSTEINE

AKOVAZ, EPHEDRINE SULFATE

BLOXIVERZ, NEOSTIGMINE METHYLSULFATE

CAFFEINE CITRATE, CAFFEINE CITRATE

CUPRIC CHLORIDE, CUPRIC CHLORIDE

ELCYS, CYSTEINE HYDROCHLORIDE

GANZYK-RTU, GANCICLOVIR

GLYRX-PF, GLYCOPYRROLATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MIDAZOLAM IN 0.8% SODIUM CHLORIDE, MIDAZOLAM

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%, SODIUM NITROPRUSSIDE

POTASSIUM ACETATE, POTASSIUM ACETATE

SODIUM BICARBONATE, SODIUM BICARBONATE

TRANEXAMIC ACID, TRANEXAMIC ACID

VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZINC CHLORIDE, ZINC CHLORIDE

EXELA PHARMA SCIENCE

* EXELA PHARMA SCIENCES

CAFFEINE CITRATE, CAFFEINE CITRATE

EXELIXIS

* EXELIXIS INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 80

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** E **

* EXELIXIS INC

COMETRIQ, CABOZANTINIB S-MALATE

EXELIXIS INC

* EXELIXIS INC

CABOMETYX, CABOZANTINIB S-MALATE

EXELTIS USA INC

* EXELTIS USA INC

SLYND, DROSPIRENONE

TYBLUME, ETHINYL ESTRADIOL

EYENOVIA

* EYENOVIA INC

MYDCOMBI, PHENYLEPHRINE HYDROCHLORIDE

EYEPOINT PHARMS

* EYEPOINT PHARMACEUTICALS INC

DEXYCU KIT, DEXAMETHASONE

EYWA

* EYWA PHARMA INC

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

NIACIN, NIACIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

VALPROIC ACID, VALPROIC ACID

EYWA PHARMA

* EYWA PHARMA PTE LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

BACLOFEN, BACLOFEN

URSODIOL, URSODIOL

EZRA VENTURES

* EZRA VENTURES LLC

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

LILLY

* ELI LILLY AND CO

ALIMTA, PEMETREXED DISODIUM

CIALIS, TADALAFIL

CYMBALTA, DULOXETINE HYDROCHLORIDE

EVISTA, RALOXIFENE HYDROCHLORIDE

FORTEO, TERIPARATIDE

STRATTERA, ATOMOXETINE HYDROCHLORIDE

SYMBYAX, FLUOXETINE HYDROCHLORIDE

** F **

FABRE KRAMER

* FABRE KRAMER PHARMACEUTICALS INC

EXXUA, GEPIRONE HYDROCHLORIDE

FDC LTD

* FDC LTD

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

LATANOPROST, LATANOPROST

OFLOXACIN, OFLOXACIN

TIMOLOL MALEATE, TIMOLOL MALEATE

FDN CONSUMER

* FOUNDATION CONSUMER BRANDS LLC

ALAVERT, LORATADINE (OTC)

* FOUNDATION CONSUMER HEALTHCARE LLC

PLAN B ONE-STEP, LEVONORGESTREL (OTC)

FEINSTEIN

* FEINSTEIN INSTITUTE MEDICAL RESEARCH

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

FLUORODOPA F18, FLUORODOPA F-18
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 81

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

FENNEC PHARMS INC

* FENNEC PHARMACEUTICALS INC

PEDMARK, SODIUM THIOSULFATE

FERA PHARMS LLC

* FERA PHARMACEUTICALS LLC

GENTAMICIN SULFATE, GENTAMICIN SULFATE

PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE

FERRER INTERNACIONAL

* FERRER INTERNACIONAL SA

XEPI, OZENOXACIN

FERRING

* FERRING PHARMACEUTICALS INC

ENDOMETRIN, PROGESTERONE

FIRMAGON, DEGARELIX ACETATE

FERRING PHARMS INC

* FERRING PHARMACEUTICALS INC

CERVIDIL, DINOPROSTONE

CLENPIQ, CITRIC ACID

DDAVP, DESMOPRESSIN ACETATE

FLAMINGO PHARMS

* FLAMINGO PHARMACEUTICALS LTD

METRONIDAZOLE, METRONIDAZOLE

PIROXICAM, PIROXICAM

FLORIDA

* FLORIDA PHARMACEUTICAL PRODUCTS LLC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BRIMONIDINE TARTRATE

SUMATRIPTAN, SUMATRIPTAN

FOLDRX PHARMS

* FOLDRX PHARMACEUTICALS LLC A WHOLLY OWNED SUB OF PFIZER INC

VYNDAMAX, TAFAMIDIS

VYNDAQEL, TAFAMIDIS MEGLUMINE

FOSUN PHARMA

* FOSUN PHARMA USA INC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

FOUGERA PHARMS

* FOUGERA PHARMACEUTICALS INC

ADAPALENE, ADAPALENE

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE, CALCIPOTRIENE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DESONIDE, DESONIDE

DESOXIMETASONE, DESOXIMETASONE

ERYTHROMYCIN, ERYTHROMYCIN

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE, HYDROCORTISONE

IMIQUIMOD, IMIQUIMOD

KETOCONAZOLE, KETOCONAZOLE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NYSTATIN, NYSTATIN

OXISTAT, OXICONAZOLE NITRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 82

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FOUGERA PHARMACEUTICALS INC

PREDNICARBATE, PREDNICARBATE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE

FOUGERA PHARMS INC

* FOUGERA PHARMACEUTICALS INC

ACYCLOVIR, ACYCLOVIR

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCORTISONE, HYDROCORTISONE

LIDOCAINE, LIDOCAINE

NITROGLYCERIN, NITROGLYCERIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

TACROLIMUS, TACROLIMUS

TERCONAZOLE, TERCONAZOLE

FRESENIUS

* FRESENIUS KABI DEUTSCHLAND GMBH

INTRALIPID 20%, SOYBEAN OIL

INTRALIPID 30%, SOYBEAN OIL

* FRESENIUS KABI IPSUM SRL

NAFCILLIN SODIUM, NAFCILLIN SODIUM

FRESENIUS KABI

* FRESENIUS KABI ANTI INFECTIVES SRL

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

* FRESENIUS KABI AUSTRIA GMBH

LACTULOSE, LACTULOSE

FRESENIUS KABI USA

* FRESENIUS KABI USA LLC

ACETAMINOPHEN, ACETAMINOPHEN

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ADENOSINE, ADENOSINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ATROPINE SULFATE, ATROPINE SULFATE

AZITHROMYCIN, AZITHROMYCIN

AZTREONAM, AZTREONAM

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BIVALIRUDIN, BIVALIRUDIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BORTEZOMIB, BORTEZOMIB

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE

CALCIUM GLUCONATE, CALCIUM GLUCONATE

CARBOPLATIN, CARBOPLATIN

CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CEFOTETAN, CEFOTETAN DISODIUM

CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISPLATIN, CISPLATIN

CLADRIBINE, CLADRIBINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 83

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS KABI USA LLC

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAPTOMYCIN, DAPTOMYCIN

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%, DEXTROSE

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15%, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225%, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9%, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DIAZEPAM, DIAZEPAM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

DIMENHYDRINATE, DIMENHYDRINATE

DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE

DIPRIVAN, PROPOFOL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXY 100, DOXYCYCLINE HYCLATE

DOXY 200, DOXYCYCLINE HYCLATE

EPHEDRINE SULFATE, EPHEDRINE SULFATE

ETOPOSIDE, ETOPOSIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL CITRATE, FENTANYL CITRATE

FLOXURIDINE, FLOXURIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FOSCARNET SODIUM, FOSCARNET SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FULVESTRANT, FULVESTRANT

FUROSEMIDE, FUROSEMIDE

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLUCAGON, GLUCAGON HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

ICATIBANT ACETATE, ICATIBANT ACETATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 84

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS KABI USA LLC

IFOSFAMIDE, IFOSFAMIDE

INDOMETHACIN, INDOMETHACIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LACOSAMIDE, LACOSAMIDE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANNITOL 25%, MANNITOL

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MESNA, MESNA

METHOCARBAMOL, METHOCARBAMOL

METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5, MAGNESIUM CHLORIDE

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4, MAGNESIUM CHLORIDE

NAROPIN, ROPIVACAINE HYDROCHLORIDE

NEBUPENT, PENTAMIDINE ISETHIONATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NESACAINE, CHLOROPROCAINE HYDROCHLORIDE

NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OMEGAVEN, FISH OIL TRIGLYCERIDES

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXACILLIN SODIUM, OXACILLIN SODIUM

OXALIPLATIN, OXALIPLATIN

OXYTOCIN, OXYTOCIN

PACLITAXEL, PACLITAXEL

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PENTAM, PENTAMIDINE ISETHIONATE

PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

POLOCAINE, MEPIVACAINE HYDROCHLORIDE

POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

POSACONAZOLE, POSACONAZOLE

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45%, POTASSIUM CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 85

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS KABI USA LLC

POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE

POTASSIUM CHLORIDE 10MEQ, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%, DEXTROSE

POTASSIUM CHLORIDE 20MEQ, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%, DEXTROSE

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%, DEXTROSE

POTASSIUM CHLORIDE 40MEQ, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, DIBASIC

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTAMINE SULFATE, PROTAMINE SULFATE

PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE

REMIFENTANIL HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROMIDEPSIN, ROMIDEPSIN

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SENSORCAINE, BUPIVACAINE HYDROCHLORIDE

SMOFLIPID 20%, FISH OIL

SODIUM ACETATE, SODIUM ACETATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 14.6%, SODIUM CHLORIDE

SODIUM CHLORIDE 23.4%, SODIUM CHLORIDE

SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM PHOSPHATES, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TIGECYCLINE, TIGECYCLINE

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID

VALPROATE SODIUM, VALPROATE SODIUM

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VASOPRESSIN, VASOPRESSIN

VIBISONE, CYANOCOBALAMIN

VINBLASTINE SULFATE, VINBLASTINE SULFATE

XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE

XYLOCAINE, LIDOCAINE HYDROCHLORIDE

ZINC SULFATE, ZINC SULFATE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

FRESENIUS MEDCL

* FRESENIUS MEDICAL CARE NORTH AMERICA

DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM

DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 86

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** F **

* FRESENIUS MEDICAL CARE NORTH AMERICA

PHOSLO GELCAPS, CALCIUM ACETATE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

** G **

G1 THERAP

* G1 THERAPEUTICS INC

COSELA, TRILACICLIB DIHYDROCHLORIDE

GALDERMA LABS

* GALDERMA LABORATORIES INC

CLOBEX, CLOBETASOL PROPIONATE

EPIDUO FORTE, ADAPALENE

GALDERMA LABS LP

* GALDERMA LABORATORIES L P

CLOBEX, CLOBETASOL PROPIONATE

* GALDERMA LABORATORIES LP

AKLIEF, TRIFAROTENE

CAPEX, FLUOCINOLONE ACETONIDE

CLOBEX, CLOBETASOL PROPIONATE

DESOWEN, DESONIDE

DIFFERIN, ADAPALENE

DIFFERIN, ADAPALENE (OTC)

EPIDUO, ADAPALENE

EPSOLAY, BENZOYL PEROXIDE

METROCREAM, METRONIDAZOLE

METROGEL, METRONIDAZOLE

METROLOTION, METRONIDAZOLE

MIRVASO, BRIMONIDINE TARTRATE

ORACEA, DOXYCYCLINE

SOOLANTRA, IVERMECTIN

TRI-LUMA, FLUOCINOLONE ACETONIDE

TWYNEO, BENZOYL PEROXIDE

VECTICAL, CALCITRIOL

GALT PHARMS

* GALT PHARMACEUTICALS LLC

DORAL, QUAZEPAM

ORAVIG, MICONAZOLE

ORPHENGESIC FORTE, ASPIRIN

ORPHENGESIC, ASPIRIN

GE HEALTHCARE

* GE HEALTHCARE

ADREVIEW, IOBENGUANE SULFATE I-123

CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT

CERIANNA, FLUOROESTRADIOL F-18

CLARISCAN, GADOTERATE MEGLUMINE

INDIUM IN 111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE

MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM

MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT

MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT

OMNIPAQUE 12, IOHEXOL

OMNIPAQUE 140, IOHEXOL

OMNIPAQUE 180, IOHEXOL

OMNIPAQUE 240, IOHEXOL

OMNIPAQUE 300, IOHEXOL

OMNIPAQUE 350, IOHEXOL

OMNIPAQUE 9, IOHEXOL

OMNISCAN, GADODIAMIDE

OPTISON, ALBUMIN HUMAN

VISIPAQUE 270, IODIXANOL

VISIPAQUE 320, IODIXANOL

VIZAMYL, FLUTEMETAMOL F-18

GE HLTHCARE INC

* GE HEALTHCARE INC

DATSCAN, IOFLUPANE I-123

GENBIOPRO
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 87

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GENBIOPRO INC

MIFEPRISTONE, MIFEPRISTONE

GENENTECH

* GENENTECH INC

ERIVEDGE, VISMODEGIB

GENENTECH INC

* GENENTECH INC

COTELLIC, COBIMETINIB FUMARATE

ESBRIET, PIRFENIDONE

EVRYSDI, RISDIPLAM

GAVRETO, PRALSETINIB

ROZLYTREK, ENTRECTINIB

XOFLUZA, BALOXAVIR MARBOXIL

GENERICS

* GENERICS INTERNATIONAL VENTURES ENTERPRISES LLC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

GENEYORK PHARMS

* GENEYORK PHARMACEUTICALS GROUP LLC

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

PREDNISONE, PREDNISONE

GENSCO

* GENSCO LABORATORIES LLC DBA GENSCO PHARMA

RIZAFILM, RIZATRIPTAN BENZOATE

GENUS

* GENUS LIFESCIENCES INC

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

HYCODAN, HOMATROPINE METHYLBROMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

NYSTATIN, NYSTATIN

GENUS LIFESCIENCES

* GENUS LIFE SCIENCES INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMCINONIDE, AMCINONIDE

GOPRELTO, COCAINE HYDROCHLORIDE

LEVOLET, LEVOTHYROXINE SODIUM **

MONOKET, ISOSORBIDE MONONITRATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

GENZYME

* GENZYME CORP

CLOLAR, CLOFARABINE

MOZOBIL, PLERIXAFOR

RENAGEL, SEVELAMER HYDROCHLORIDE

RENVELA, SEVELAMER CARBONATE

GENZYME CORP

* GENZYME CORP

CAPRELSA, VANDETANIB

CERDELGA, ELIGLUSTAT TARTRATE

GILEAD

* GILEAD SCIENCES INC

CAYSTON, AZTREONAM

EMTRIVA, EMTRICITABINE

HEPSERA, ADEFOVIR DIPIVOXIL

LETAIRIS, AMBRISENTAN

TRUVADA, EMTRICITABINE

GILEAD SCIENCES

* GILEAD SCIENCES LLC

ATRIPLA, EFAVIRENZ

GILEAD SCIENCES INC

* GILEAD SCIENCES INC

BIKTARVY, BICTEGRAVIR SODIUM

COMPLERA, EMTRICITABINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 88

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GILEAD SCIENCES INC

DESCOVY, EMTRICITABINE

EPCLUSA, SOFOSBUVIR

GENVOYA, COBICISTAT

HARVONI, LEDIPASVIR

ODEFSEY, EMTRICITABINE

SOVALDI, SOFOSBUVIR

STRIBILD, COBICISTAT

SUNLENCA, LENACAPAVIR SODIUM

TYBOST, COBICISTAT

VEKLURY, REMDESIVIR

VEMLIDY, TENOFOVIR ALAFENAMIDE FUMARATE

VIREAD, TENOFOVIR DISOPROXIL FUMARATE

VOSEVI, SOFOSBUVIR

ZYDELIG, IDELALISIB

GISKIT

* GISKIT PHARMA BV

EXEM FOAM KIT, AIR POLYMER-TYPE A

GLAND

* GLAND PHARMA LTD

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

MEROPENEM, MEROPENEM

MESNA, MESNA

OXALIPLATIN, OXALIPLATIN

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TRANEXAMIC ACID, TRANEXAMIC ACID

VECURONIUM BROMIDE, VECURONIUM BROMIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

GLAND PHARMA LTD

* GLAND PHARMA LTD

ADENOSINE, ADENOSINE

ALLOPURINOL SODIUM, ALLOPURINOL SODIUM

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ARGATROBAN, ARGATROBAN

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

BIMATOPROST, BIMATOPROST

BROMFENAC SODIUM, BROMFENAC SODIUM

BUMETANIDE, BUMETANIDE

CALCITRIOL, CALCITRIOL

CARBOPLATIN, CARBOPLATIN

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CISPLATIN, CISPLATIN

CLOFARABINE, CLOFARABINE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYTARABINE, CYTARABINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DOCETAXEL, DOCETAXEL

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 89

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAND PHARMA LTD

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

EPHEDRINE SULFATE, EPHEDRINE SULFATE

ERTAPENEM SODIUM, ERTAPENEM SODIUM

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ETOMIDATE, ETOMIDATE

FLUOROURACIL, FLUOROURACIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FOMEPIZOLE, FOMEPIZOLE

FOSCARNET SODIUM, FOSCARNET SODIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GANIRELIX ACETATE, GANIRELIX ACETATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LACOSAMIDE, LACOSAMIDE

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOFLOXACIN, LEVOFLOXACIN

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LINCOMYCIN HYDROCHLORIDE, LINCOMYCIN HYDROCHLORIDE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NELARABINE, NELARABINE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC)

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

POSACONAZOLE, POSACONAZOLE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

REGADENOSON, REGADENOSON

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TEMSIROLIMUS, TEMSIROLIMUS

THIOTEPA, THIOTEPA

TIMOLOL MALEATE, TIMOLOL MALEATE

TIROFIBAN HYDROCHLORIDE, TIROFIBAN HYDROCHLORIDE

TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOBRAMYCIN, TOBRAMYCIN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZINC SULFATE, ZINC SULFATE

ZIPRASIDONE MESYLATE, ZIPRASIDONE MESYLATE

ZOLEDRONIC ACID, ZOLEDRONIC ACID
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 90

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAND PHARMA LTD

ZOLEDRONIC, ZOLEDRONIC ACID

GLAUKOS

* GLAUKOS CORP

IDOSE TR, TRAVOPROST

PHOTREXA VISCOUS IN DEXTRAN 20%, RIBOFLAVIN 5'-PHOSPHATE

PHOTREXA, RIBOFLAVIN 5'-PHOSPHATE

GLAXO GRP ENGLAND

* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

INCRUSE ELLIPTA, UMECLIDINIUM BROMIDE

GLAXO GRP LTD

* GLAXO GROUP LTD DBA GLAXOSMITHKLINE

FLOVENT HFA, FLUTICASONE PROPIONATE

* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE

ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE

ADVAIR HFA, FLUTICASONE PROPIONATE

BREO ELLIPTA, FLUTICASONE FUROATE

FLOVENT DISKUS 100, FLUTICASONE PROPIONATE

FLOVENT DISKUS 250, FLUTICASONE PROPIONATE

FLOVENT DISKUS 50, FLUTICASONE PROPIONATE

GLAXOSMITHKLINE

* GLAXOSMITHKLINE

ABREVA, DOCOSANOL (OTC)

EPIVIR-HBV, LAMIVUDINE

IMITREX STATDOSE, SUMATRIPTAN SUCCINATE

IMITREX, SUMATRIPTAN

IMITREX, SUMATRIPTAN SUCCINATE

MALARONE PEDIATRIC, ATOVAQUONE

MALARONE, ATOVAQUONE

NICORETTE (MINT), NICOTINE POLACRILEX (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

RELENZA, ZANAMIVIR

VALTREX, VALACYCLOVIR HYDROCHLORIDE

WELLBUTRIN SR, BUPROPION HYDROCHLORIDE

* GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS US LLC

ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL COLD AND SINUS, IBUPROFEN (OTC)

ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)

ADVIL DUAL ACTION WITH ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ADVIL LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)

ADVIL MULTI-SYMPTOM COLD & FLU, CHLORPHENIRAMINE MALEATE (OTC)

ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)

ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

ADVIL, IBUPROFEN (OTC)

ADVIL, IBUPROFEN SODIUM (OTC)

AXID AR, NIZATIDINE (OTC)

CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)

CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)

CHILDREN'S ADVIL, IBUPROFEN (OTC)

CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)

INFANT'S ADVIL, IBUPROFEN (OTC)

JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)

LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND

ANORO ELLIPTA, UMECLIDINIUM BROMIDE

ARNUITY ELLIPTA, FLUTICASONE FUROATE

KRINTAFEL, TAFENOQUINE SUCCINATE

TRELEGY ELLIPTA, FLUTICASONE FUROATE

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

SEREVENT, SALMETEROL XINAFOATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 91

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

VENTOLIN HFA, ALBUTEROL SULFATE

* GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND

JESDUVROQ, DAPRODUSTAT

* GLAXOSMITHKLINE LLC

OJJAARA, MOMELOTINIB DIHYDROCHLORIDE

ZEJULA, NIRAPARIB TOSYLATE

GLAXOSMITHKLINE CONS

* GLAXOSMITHKLINE CONSUMER HEALTHCARE

ALLI, ORLISTAT (OTC)

EXCEDRIN (MIGRAINE RELIEF), ACETAMINOPHEN (OTC)

FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC)

FLONASE SENSIMIST ALLERGY RELIEF, FLUTICASONE FUROATE (OTC)

LAMISIL AT, TERBINAFINE (OTC)

LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)

NICORETTE, NICOTINE POLACRILEX (OTC)

VOLTAREN ARTHRITIS PAIN, DICLOFENAC SODIUM (OTC)

GLAXOSMITHKLINE LLC

* GLAXOSMITHKLINE LLC

FLOLAN, EPOPROSTENOL SODIUM

LAMICTAL CD, LAMOTRIGINE

LAMICTAL ODT, LAMOTRIGINE

LAMICTAL XR, LAMOTRIGINE

LAMICTAL, LAMOTRIGINE

MEPRON, ATOVAQUONE

GLENMARK GENERICS

* GLENMARK GENERICS INC USA

ADAPALENE, ADAPALENE (OTC)

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

IMIQUIMOD, IMIQUIMOD

MOMETASONE FUROATE, MOMETASONE FUROATE

NIZATIDINE, NIZATIDINE

ZONISAMIDE, ZONISAMIDE

* GLENMARK GENERICS LIMITED

BRIELLYN, ETHINYL ESTRADIOL

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

* GLENMARK GENERICS LTD

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

ALYACEN 1/35, ETHINYL ESTRADIOL

ALYACEN 7/7/7, ETHINYL ESTRADIOL

ASHLYNA, ETHINYL ESTRADIOL

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

CARVEDILOL, CARVEDILOL

CICLOPIROX, CICLOPIROX

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DESOXIMETASONE, DESOXIMETASONE

ESZOPICLONE, ESZOPICLONE

FELODIPINE, FELODIPINE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE, FLUOCINONIDE

HEATHER, NORETHINDRONE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

LEVOFLOXACIN, LEVOFLOXACIN

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LITHIUM CARBONATE, LITHIUM CARBONATE

MARLISSA, ETHINYL ESTRADIOL

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NAPROXEN, NAPROXEN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 92

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLENMARK GENERICS LTD

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

OMEPRAZOLE, OMEPRAZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TOPIRAMATE, TOPIRAMATE

TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

URSODIOL, URSODIOL

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VIORELE, DESOGESTREL

ZOLMITRIPTAN, ZOLMITRIPTAN

* GLENMARK GENERICS LTD INDIA

INDOMETHACIN, INDOMETHACIN

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

GLENMARK PHARMS

* GLENMARK PHARMACEUTICALS INC

TERIFLUNOMIDE, TERIFLUNOMIDE

* GLENMARK PHARMACEUTICALS INC USA

CICLOPIROX, CICLOPIROX

CLOTRIMAZOLE, CLOTRIMAZOLE

MUPIROCIN, MUPIROCIN

* GLENMARK PHARMACEUTICALS LTD

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

* GLENMARK PHARMACEUTICALS SA

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ATOVAQUONE, ATOVAQUONE

AZELAIC ACID, AZELAIC ACID

CALCIPOTRIENE, CALCIPOTRIENE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

DESONIDE, DESONIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

HAILEY 1.5/30, ETHINYL ESTRADIOL

HAILEY FE 1.5/30, ETHINYL ESTRADIOL

LINEZOLID, LINEZOLID

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

GLENMARK PHARMS INC

* GLENMARK PHARMACEUTICALS INC USA

CALCIPOTRIENE, CALCIPOTRIENE

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

FULVESTRANT, FULVESTRANT

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LITHIUM CARBONATE, LITHIUM CARBONATE

MUPIROCIN, MUPIROCIN CALCIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

GLENMARK PHARMS LTD

* GLENMARK PHARMACEUTICALS LTD

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

APREMILAST, APREMILAST
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 93

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GLENMARK PHARMACEUTICALS LTD

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESONIDE, DESONIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ESTRADIOL, ESTRADIOL

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

EZETIMIBE, EZETIMIBE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

GABAPENTIN, GABAPENTIN

HAILEY 24 FE, ETHINYL ESTRADIOL

HAILEY FE 1/20, ETHINYL ESTRADIOL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

INDOMETHACIN, INDOMETHACIN

LACOSAMIDE, LACOSAMIDE

LAMOTRIGINE, LAMOTRIGINE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

LIDOCAINE, LIDOCAINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

NAPROXEN SODIUM, NAPROXEN SODIUM

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OXCARBAZEPINE, OXCARBAZEPINE

PIMECROLIMUS, PIMECROLIMUS

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RANOLAZINE, RANOLAZINE

RILUZOLE, RILUZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

RUFINAMIDE, RUFINAMIDE

SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE

SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE

SIROLIMUS, SIROLIMUS

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

TACROLIMUS, TACROLIMUS

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

THEOPHYLLINE, THEOPHYLLINE

TOPIRAMATE, TOPIRAMATE

TRETINOIN, TRETINOIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VORICONAZOLE, VORICONAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 94

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

GLENMARK PHARMS SA

* GLENMARK PHARMACEUTICALS SA SWITZERLAND

ACYCLOVIR, ACYCLOVIR

APREPITANT, APREPITANT

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

NITROGLYCERIN, NITROGLYCERIN

GLENMARK SPECIALTY

* GLENMARK SPECIALTY SA

RYALTRIS, MOMETASONE FUROATE

GLOBAL BLOOD THERAPS

* GLOBAL BLOOD THERAPEUTICS INC

OXBRYTA, VOXELOTOR

GLW

* GLW PHARMA GMBH

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

GRANULATION TECH

* GRANULATION TECHNOLOGY INC

PREDNISONE, PREDNISONE

GRANULES

* GRANULES INDIA LTD

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

GABAPENTIN, GABAPENTIN

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LEVETIRACETAM, LEVETIRACETAM

LORATADINE, LORATADINE (OTC)

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

NAPROXEN, NAPROXEN

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

* GRANULES PHARMACEUTICALS INC

ACETAMINOPHEN AND IBUPROFEN, ACETAMINOPHEN (OTC)

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

COLCHICINE, COLCHICINE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DOFETILIDE, DOFETILIDE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

PENICILLAMINE, PENICILLAMINE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

RAMELTEON, RAMELTEON

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

GRANULES INDIA

* GRANULES INDIA LTD

IBUPROFEN, IBUPROFEN (OTC)
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 95

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** G **

* GRANULES INDIA LTD

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

GRAVITI PHARMS

* GRAVITI PHARMACEUTICALS INC

GABAPENTIN, GABAPENTIN

MONTELUKAST SODIUM, MONTELUKAST SODIUM

* GRAVITI PHARMACEUTICALS PRIVATE LTD

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BACLOFEN, BACLOFEN

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FUROSEMIDE, FUROSEMIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

GUANGZHOU NOVAKEN

* GUANGZHOU NOVAKEN PHARMACEUTICAL CO LTD

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

GUARDIAN DRUG

* GUARDIAN DRUG CO

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

GUERBET

* GUERBET

ELUCIREM, GADOPICLENOL

* GUERBET LLC

DOTAREM, GADOTERATE MEGLUMINE

LIPIODOL, ETHIODIZED OIL

** H **

HAEMONETICS

* HAEMONETICS CORP

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

HAINAN POLY

* HAINAN POLY PHARM CO LTD

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

AZITHROMYCIN, AZITHROMYCIN

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

FLUCONAZOLE, FLUCONAZOLE

IOPAMIDOL, IOPAMIDOL

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

HAINAN POLY PHARM

* HAINAN POLY PHARMACEUTICAL CO LTD

DAPTOMYCIN, DAPTOMYCIN

GADOBUTROL, GADOBUTROL

LEVETIRACETAM, LEVETIRACETAM

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

HALOCARBON PRODS

* HALOCARBON PRODUCTS CORP
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 96

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HALOCARBON PRODUCTS CORP

ISOFLURANE, ISOFLURANE

SEVOFLURANE, SEVOFLURANE

HANGZHOU BINJIANG

* HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO LTD

ALENDRONATE SODIUM, ALENDRONATE SODIUM

HANGZHOU ZHONGMEI

* HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTD

DAPTOMYCIN, DAPTOMYCIN

TACROLIMUS, TACROLIMUS

HARM REDUCTION THERP

* HARM REDUCTION THERAPEUTICS INC

RIVIVE, NALOXONE HYDROCHLORIDE (OTC)

HARMAN FINOCHEM

* HARMAN FINOCHEM LTD

ALLOPURINOL, ALLOPURINOL

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

HARMONY

* HARMONY BIOSCIENCES LLC

WAKIX, PITOLISANT HYDROCHLORIDE

HARROW EYE

* HARROW EYE LLC

FLAREX, FLUOROMETHOLONE ACETATE

IHEEZO, CHLOROPROCAINE HYDROCHLORIDE

ILEVRO, NEPAFENAC

IOPIDINE, APRACLONIDINE HYDROCHLORIDE

MAXIDEX, DEXAMETHASONE

MAXITROL, DEXAMETHASONE

NATACYN, NATAMYCIN

NEVANAC, NEPAFENAC

TOBRADEX ST, DEXAMETHASONE

TRIESENCE, TRIAMCINOLONE ACETONIDE

VERKAZIA, CYCLOSPORINE

VEVYE, CYCLOSPORINE

ZERVIATE, CETIRIZINE HYDROCHLORIDE

HBT LABS INC

* HBT LABS INC

FULVESTRANT, FULVESTRANT

HEC PHARM

* HEC PHARM USA INC

CLARITHROMYCIN, CLARITHROMYCIN

LEVOFLOXACIN, LEVOFLOXACIN

OLANZAPINE, OLANZAPINE

PRASUGREL, PRASUGREL HYDROCHLORIDE

HEC PHARM CO LTD

* HEC PHARM CO LTD

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

HELSINN

* HELSINN BIREX PHARMACEUTICALS LTD

VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE

HELSINN HLTHCARE

* HELSINN HEALTHCARE SA

AKYNZEO, FOSNETUPITANT CHLORIDE HYDROCHLORIDE

AKYNZEO, NETUPITANT

HERITAGE LIFE

* HERITAGE LIFE SCIENCES BARBADOS INC

CLOZARIL, CLOZAPINE

HERITAGE PHARMA

* HERITAGE PHARMA LABS INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAZOLAMIDE, ACETAZOLAMIDE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 97

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HERITAGE PHARMA LABS INC

BUMETANIDE, BUMETANIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIFLUNISAL, DIFLUNISAL

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

METHIMAZOLE, METHIMAZOLE

NIFEDIPINE, NIFEDIPINE

HERITAGE PHARMA AVET

* HERITAGE PHARMA LABS INC DBA AVET PHARMACEUTICALS LABS INC

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

HERITAGE PHARMS

* HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC

ACYCLOVIR, ACYCLOVIR

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

FELODIPINE, FELODIPINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

GLYBURIDE, GLYBURIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LEFLUNOMIDE, LEFLUNOMIDE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

NYSTATIN, NYSTATIN

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

HERITAGE PHARMS INC

* HERITAGE PHARMACEUTICALS INC

CALCIUM ACETATE, CALCIUM ACETATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

ETHOSUXIMIDE, ETHOSUXIMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

HERITAGE PHARMS LABS

* HERITAGE PHARMACEUTICALS LABS INC DBA AVET PHARMACEUTICALS LABS INC

BENZONATATE, BENZONATATE

HERON THERAPS INC

* HERON THERAPEUTICS INC

APONVIE, APREPITANT

CINVANTI, APREPITANT

SUSTOL, GRANISETRON

ZYNRELEF KIT, BUPIVACAINE

HETERO LABS

* HETERO LABS LTD

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LINEZOLID, LINEZOLID

HETERO LABS LTD III

* HETERO LABS LTD UNIT III
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 98

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HETERO LABS LTD UNIT III

ABACAVIR SULFATE, ABACAVIR SULFATE

ACYCLOVIR, ACYCLOVIR

ARIPIPRAZOLE, ARIPIPRAZOLE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATOVAQUONE, ATOVAQUONE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOBAZAM, CLOBAZAM

DABIGATRAN ETEXILATE MESYLATE, DABIGATRAN ETEXILATE MESYLATE

DARUNAVIR, DARUNAVIR

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

EFAVIRENZ, EFAVIRENZ

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

EZETIMIBE, EZETIMIBE

FENOFIBRATE, FENOFIBRATE

FINASTERIDE, FINASTERIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LACOSAMIDE, LACOSAMIDE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LANSOPRAZOLE, LANSOPRAZOLE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

LEVOCETIRIZINE HYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

LOPINAVIR AND RITONAVIR, LOPINAVIR

LORATADINE, LORATADINE (OTC)

MARAVIROC, MARAVIROC

METHOCARBAMOL, METHOCARBAMOL

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NAPROXEN, NAPROXEN

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

NEVIRAPINE, NEVIRAPINE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

OMEPRAZOLE, OMEPRAZOLE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXCARBAZEPINE, OXCARBAZEPINE

POSACONAZOLE, POSACONAZOLE

PREGABALIN, PREGABALIN

RANOLAZINE, RANOLAZINE

RITONAVIR, RITONAVIR

ROFLUMILAST, ROFLUMILAST

RUFINAMIDE, RUFINAMIDE

SIMVASTATIN, SIMVASTATIN

TADALAFIL, TADALAFIL

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TORSEMIDE, TORSEMIDE

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

VARENICLINE TARTRATE, VARENICLINE TARTRATE

ZIDOVUDINE, ZIDOVUDINE

HETERO LABS LTD V

* HETERO LABS LTD UNIT V

ACYCLOVIR, ACYCLOVIR

ALLOPURINOL, ALLOPURINOL

APIXABAN, APIXABAN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 99

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HETERO LABS LTD UNIT V

ARIPIPRAZOLE, ARIPIPRAZOLE

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BREXPIPRAZOLE, BREXPIPRAZOLE

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

COLCHICINE, COLCHICINE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

ENTECAVIR, ENTECAVIR

ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE

ESZOPICLONE, ESZOPICLONE

FAMCICLOVIR, FAMCICLOVIR

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

IRBESARTAN, IRBESARTAN

LACOSAMIDE, LACOSAMIDE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LENALIDOMIDE, LENALIDOMIDE

LEVOFLOXACIN, LEVOFLOXACIN

LINEZOLID, LINEZOLID

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PIRFENIDONE, PIRFENIDONE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID, CITRIC ACID

TELMISARTAN, TELMISARTAN

TERIFLUNOMIDE, TERIFLUNOMIDE

TETRABENAZINE, TETRABENAZINE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TOLVAPTAN, TOLVAPTAN

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

HEYL CHEMISCH

* HEYL CHEMISCH PHARMAZEUTISHE FABRIK

RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)

HIKMA

* HIKMA FARMACEUTICA PORTUGAL SA

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE

CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM

CEFUROXIME SODIUM, CEFUROXIME SODIUM

DOCETAXEL, DOCETAXEL

ESTRADIOL VALERATE, ESTRADIOL VALERATE

ETOMIDATE, ETOMIDATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 100

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA FARMACEUTICA PORTUGAL SA

VECURONIUM BROMIDE, VECURONIUM BROMIDE

* HIKMA PHARMACEUTICALS

AMOXICILLIN, AMOXICILLIN

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

* HIKMA PHARMACEUTICALS INTERNATIONAL LTD

CODEINE SULFATE, CODEINE SULFATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

FUROSEMIDE, FUROSEMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

RUFINAMIDE, RUFINAMIDE

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

* HIKMA PHARMACEUTICALS LLC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

DANTROLENE SODIUM, DANTROLENE SODIUM

DOXERCALCIFEROL, DOXERCALCIFEROL

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

* HIKMA PHARMACEUTICALS USA INC

ACARBOSE, ACARBOSE

ACETAMINOPHEN, ACETAMINOPHEN

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ACYCLOVIR, ACYCLOVIR

ADENOSINE, ADENOSINE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALLOPURINOL SODIUM, ALLOPURINOL SODIUM

ALPRAZOLAM, ALPRAZOLAM

ALPROSTADIL, ALPROSTADIL

ALVIMOPAN, ALVIMOPAN

AMICAR, AMINOCAPROIC ACID

AMIKACIN SULFATE, AMIKACIN SULFATE

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMRINONE LACTATE, INAMRINONE LACTATE

ATIVAN, LORAZEPAM

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

ATROPINE SULFATE, ATROPINE SULFATE

AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BEXAROTENE, BEXAROTENE

BIMATOPROST, BIMATOPROST

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CAFCIT, CAFFEINE CITRATE

CALCIPOTRIENE, CALCIPOTRIENE

CALCITRIOL, CALCITRIOL

CALCIUM ACETATE, CALCIUM ACETATE

CAPECITABINE, CAPECITABINE

CARBOPLATIN, CARBOPLATIN

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFOXITIN, CEFOXITIN SODIUM

CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 101

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA PHARMACEUTICALS USA INC

CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE

CICLOPIROX, CICLOPIROX

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CISPLATIN, CISPLATIN

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLADRIBINE, CLADRIBINE

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

COMBOGESIC IV, ACETAMINOPHEN

CORMAX, CLOBETASOL PROPIONATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

CYCLOSPORINE, CYCLOSPORINE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DEFERIPRONE, DEFERIPRONE

DESONIDE, DESONIDE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DEXAMETHASONE INTENSOL, DEXAMETHASONE

DEXAMETHASONE, DEXAMETHASONE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE

DIAZEPAM INTENSOL, DIAZEPAM

DIAZEPAM, DIAZEPAM

DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC)

DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE), DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DIPYRIDAMOLE, DIPYRIDAMOLE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPRAM, DOXAPRAM HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DRONABINOL, DRONABINOL

DURAMORPH PF, MORPHINE SULFATE

EMBELINE, CLOBETASOL PROPIONATE

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETOMIDATE, ETOMIDATE

ETOPOSIDE, ETOPOSIDE

EVEROLIMUS, EVEROLIMUS

EXEMESTANE, EXEMESTANE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FEBUXOSTAT, FEBUXOSTAT

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FENTANYL CITRATE, FENTANYL CITRATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLOXURIDINE, FLOXURIDINE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUMAZENIL, FLUMAZENIL

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE (OTC)

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 102

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA PHARMACEUTICALS USA INC

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

GATIFLOXACIN, GATIFLOXACIN

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM, HEPARIN SODIUM

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

ICOSAPENT ETHYL, ICOSAPENT ETHYL

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IMMPHENTIV, PHENYLEPHRINE HYDROCHLORIDE

INFUMORPH, MORPHINE SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

KLOXXADO, NALOXONE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE IN DEXTROSE, LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE, LABETALOL HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LACTULOSE, LACTULOSE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOCARNITINE, LEVOCARNITINE

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LIDOCAINE AND PRILOCAINE, LIDOCAINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE

LINEZOLID, LINEZOLID

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LITHIUM CARBONATE, LITHIUM CARBONATE

LORAZEPAM INTENSOL, LORAZEPAM

LORAZEPAM, LORAZEPAM

MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MERCAPTOPURINE, MERCAPTOPURINE

MESNA, MESNA

METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM IN 0.9% SODIUM CHLORIDE, MIDAZOLAM

MILRINONE LACTATE, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NALOXONE, NALOXONE HYDROCHLORIDE

NAPROXEN, NAPROXEN

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 103

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA PHARMACEUTICALS USA INC

OFLOXACIN, OFLOXACIN

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

PACLITAXEL, PACLITAXEL

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

POSACONAZOLE, POSACONAZOLE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PREDNISONE INTENSOL, PREDNISONE

PREDNISONE, PREDNISONE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROPOFOL, PROPOFOL

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

PYRAZINAMIDE, PYRAZINAMIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RAMIPRIL, RAMIPRIL

REGADENOSON, REGADENOSON

REMIFENTANIL HYDROCHLORIDE, REMIFENTANIL HYDROCHLORIDE

RIFAMPIN, RIFAMPIN

RISPERIDONE, RISPERIDONE

ROBAXIN, METHOCARBAMOL

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

RUFINAMIDE, RUFINAMIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SODIUM TETRADECYL SULFATE, SODIUM TETRADECYL SULFATE

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUFENTANIL CITRATE, SUFENTANIL CITRATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

THIOTEPA, THIOTEPA

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TOBRAMYCIN, TOBRAMYCIN

TORSEMIDE, TORSEMIDE

TRIAZOLAM, TRIAZOLAM

VALPROIC ACID, VALPROIC ACID

VALRUBICIN, VALRUBICIN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VIGABATRIN, VIGABATRIN

VINBLASTINE SULFATE, VINBLASTINE SULFATE

VINORELBINE TARTRATE, VINORELBINE TARTRATE

VOSOL, ACETIC ACID, GLACIAL

XOPENEX, LEVALBUTEROL HYDROCHLORIDE

ZALEPLON, ZALEPLON

HIKMA FARMACEUTICA

* HIKMA FARMACEUTICA (PORTUGAL) SA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CEFOXITIN, CEFOXITIN SODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 104

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HIKMA FARMACEUTICA (PORTUGAL) SA

CEFTRIAXONE, CEFTRIAXONE SODIUM

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CIPROFLOXACIN, CIPROFLOXACIN

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

ENALAPRILAT, ENALAPRILAT

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FLUMAZENIL, FLUMAZENIL

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE

MILRINONE LACTATE, MILRINONE LACTATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PROGESTERONE, PROGESTERONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

VALPROATE SODIUM, VALPROATE SODIUM

* HIKMA FARMACEUTICA PORTUGAL LDA

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE

* HIKMA FARMACEUTICA PORTUGAL SA

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

OXYTOCIN, OXYTOCIN

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

* HIKMA FARMACEUTICA SA

ZOLEDRONIC ACID, ZOLEDRONIC ACID

HIKMA INTL PHARMS

* HIKMA INTERNATIONAL PHARMACEUTICALS LLC

CAPTOPRIL, CAPTOPRIL

DIGOXIN, DIGOXIN

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

MITIGARE, COLCHICINE

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, NICARDIPINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

HIKMA PHARM CO LTD

* HIKMA PHARM CO LTD

ARGATROBAN, ARGATROBAN

HIKMA PHARMS

* HIKMA PHARMACEUTICALS

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

RIFAMPIN, RIFAMPIN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

* HIKMA PHARMACEUTICALS CO LTD

PARICALCITOL, PARICALCITOL

HILL DERMAC

* HILL DERMACEUTICALS INC

DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE

DERMOTIC, FLUOCINOLONE ACETONIDE

HILL DERMACEUTICALS

* HILL DERMACEUTICALS INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 105

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HILL DERMACEUTICALS INC

TOLAK, FLUOROURACIL

HISAMITSU

* HISAMITSU PHARMACEUTICAL CO INC

SECUADO, ASENAPINE

HISAMITSU PHARM CO

* HISAMITSU PHARMACEUTICAL CO INC

SALONPAS, MENTHOL (OTC)

HISUN PHARM HANGZHOU

* HISUN PHARMACEUTICAL (HANGZHOU) CO LTD

CLADRIBINE, CLADRIBINE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

OLANZAPINE, OLANZAPINE

* HISUN PHARMACEUTICAL HANGZHOU CO LTD

DACTINOMYCIN, DACTINOMYCIN

DAPTOMYCIN, DAPTOMYCIN

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

TICAGRELOR, TICAGRELOR

HLTHCARE

* HEALTHCARE PHARMACEUTICALS LTD

ATENOLOL, ATENOLOL

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

HOFFMANN LA ROCHE

* HOFFMANN LA ROCHE INC

ZELBORAF, VEMURAFENIB

HOFFMANN-LA ROCHE

* HOFFMANN-LA ROCHE INC

ALECENSA, ALECTINIB HYDROCHLORIDE

HONG KONG

* HONG KONG KING FRIEND INDUSTRIAL CO LTD

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

HOPE PHARMS

* HOPE PHARMACEUTICALS

NITHIODOTE, SODIUM NITRITE

SODIUM NITRITE, SODIUM NITRITE

SODIUM THIOSULFATE, SODIUM THIOSULFATE

HORIZON

* HORIZON MEDICINES LLC

DUEXIS, FAMOTIDINE

* HORIZON THERAPEUTICS IRELAND DAC

PENNSAID, DICLOFENAC SODIUM

* HORIZON THERAPEUTICS USA INC

PROCYSBI, CYSTEAMINE BITARTRATE

RAYOS, PREDNISONE

HORIZON THERAP US

* HORIZON THERAPEUTICS US HOLDING LLC

BUPHENYL, SODIUM PHENYLBUTYRATE

RAVICTI, GLYCEROL PHENYLBUTYRATE

HOSPIRA

* HOSPIRA INC

ACETYLCYSTEINE, ACETYLCYSTEINE

ADENOSINE, ADENOSINE

ALFENTANIL, ALFENTANIL HYDROCHLORIDE

AMIDATE, ETOMIDATE

AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID

AMINOPHYLLINE, AMINOPHYLLINE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE

ARGATROBAN, ARGATROBAN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 106

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

ATROPINE SULFATE, ATROPINE SULFATE

AZITHROMYCIN, AZITHROMYCIN

AZTREONAM, AZTREONAM

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

BIVALIRUDIN, BIVALIRUDIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BORTEZOMIB, BORTEZOMIB

BUMETANIDE, BUMETANIDE

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUSULFAN, BUSULFAN

BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE

CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE

CARBOCAINE, MEPIVACAINE HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CORLOPAM, FENOLDOPAM MESYLATE

CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DAPTOMYCIN, DAPTOMYCIN

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEMEROL, MEPERIDINE HYDROCHLORIDE

DEXTROSE 25%, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 50%, DEXTROSE

DIAZEPAM, DIAZEPAM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE

DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE

DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

ENALAPRILAT, ENALAPRILAT

EPINEPHRINE, EPINEPHRINE

ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE

FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE

FENTANYL CITRATE, FENTANYL CITRATE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

FUROSEMIDE, FUROSEMIDE

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM

HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

LEVOPHED, NOREPINEPHRINE BITARTRATE

LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 107

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, LINEZOLID

LORAZEPAM, LORAZEPAM

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE, MAGNESIUM SULFATE

MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE

MANNITOL 25%, MANNITOL

MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

MARCAINE, BUPIVACAINE HYDROCHLORIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MILRINONE LACTATE, MILRINONE LACTATE

MORPHINE SULFATE, MORPHINE SULFATE

NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

PACLITAXEL, PACLITAXEL

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PANCURONIUM BROMIDE, PANCURONIUM BROMIDE

PARICALCITOL, PARICALCITOL

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PEMETREXED DITROMETHAMINE, PEMETREXED DITROMETHAMINE

PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE

POTASSIUM ACETATE, POTASSIUM ACETATE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROPOFOL, PROPOFOL

QUELICIN, SUCCINYLCHOLINE CHLORIDE

REGADENOSON, REGADENOSON

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM ACETATE, SODIUM ACETATE

SODIUM BICARBONATE, SODIUM BICARBONATE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 14.6%, SODIUM CHLORIDE

SODIUM CHLORIDE 23.4%, SODIUM CHLORIDE

SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUFENTANIL CITRATE, SUFENTANIL CITRATE

TAZICEF, CEFTAZIDIME

THAM, TROMETHAMINE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VITAMIN K1, PHYTONADIONE

ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 108

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

* HOSPIRA INC

ZOLEDRONIC ACID, ZOLEDRONIC ACID

* HOSPIRA WORLDWIDE, INC

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE

HOSPIRA INC

* HOSPIRA INC

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

DOCETAXEL, DOCETAXEL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HEPARIN SODIUM, HEPARIN SODIUM

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

MORPHINE SULFATE, MORPHINE SULFATE

NIPENT, PENTOSTATIN

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

HOSPIRA WORLDWIDE

* HOSPIRA WORLDWIDE PTY

OXALIPLATIN, OXALIPLATIN

HOT SHOTS NM LLC

* HOT SHOTS NUCLEAR MEDICINE LLC

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

HQ SPCLT PHARMA

* HQ SPECIALTY PHARMA CORP

CALCIUM GLUCONATE IN SODIUM CHLORIDE, CALCIUM GLUCONATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CISPLATIN, CISPLATIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

IMIPENEM AND CILASTATIN, CILASTATIN SODIUM

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MEROPENEM, MEROPENEM

HQ SPECLT PHARMA

* HQ SPECIALTY PHARMA CORP

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

HRA PHARMA

* HRA PHARMA RARE DISEASES

LYSODREN, MITOTANE

METOPIRONE, METYRAPONE

HUMANWELL PURACAP

* HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

DUTASTERIDE, DUTASTERIDE

IBUPROFEN, IBUPROFEN (OTC)

ICOSAPENT ETHYL, ICOSAPENT ETHYL

HUONS

* HUONS CO LTD

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

ROCHE

* HOFFMANN LA ROCHE INC

FUZEON, ENFUVIRTIDE

TAMIFLU, OSELTAMIVIR PHOSPHATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 109

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** H **

SHUANGCHENG

* HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD

BIVALIRUDIN, BIVALIRUDIN

EPTIFIBATIDE, EPTIFIBATIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

** I **

I 3 PHARMS

* I 3 PHARMACEUTICALS LLC

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

MARAVIROC, MARAVIROC

POSACONAZOLE, POSACONAZOLE

I3 PHARMS

* I3 PHARMACEUTICALS LLC

RAMELTEON, RAMELTEON

RANOLAZINE, RANOLAZINE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

IBSA

* IBSA INSTITUT BIOCHIMIQUE SA

FLECTOR, DICLOFENAC EPOLAMINE

LIDOCAINE, LIDOCAINE

TIROSINT, LEVOTHYROXINE SODIUM

TIROSINT-SOL, LEVOTHYROXINE SODIUM

IBSA INST BIO

* IBSA INSTITUT BIOCHIMIQUE SA

LICART, DICLOFENAC EPOLAMINE

ICHNOS

* ICHNOS SCIENCES SA

DEFERASIROX, DEFERASIROX

ICU MEDICAL INC

* ICU MEDICAL INC

ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL

AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS

AMINOSYN-PF 10%, AMINO ACIDS

AMINOSYN-PF 7%, AMINO ACIDS

DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE

DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE

GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE

IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL

NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE

POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 110

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* ICU MEDICAL INC

POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,

POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM

RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION

IDORSIA

* IDORSIA PHARMACEUTICALS LTD

QUVIVIQ, DARIDOREXANT HYDROCHLORIDE

IMPACT

* IMPACT BIOMEDICINES INC A WHOLLY OWNED SUB OF CELGENE CORP

INREBIC, FEDRATINIB HYDROCHLORIDE

IMPAX

* IMPAX LABORATORIES LLC

ADRENACLICK, EPINEPHRINE

BACLOFEN, BACLOFEN

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

IMPAX LABS

* IMPAX LABORATORIES INC

ACARBOSE, ACARBOSE

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

DANTROLENE SODIUM, DANTROLENE SODIUM

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DIGOXIN, DIGOXIN

DIPYRIDAMOLE, DIPYRIDAMOLE

FENOFIBRATE, FENOFIBRATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

OMEPRAZOLE, OMEPRAZOLE

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RILUZOLE, RILUZOLE

RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TERBUTALINE SULFATE, TERBUTALINE SULFATE

IMPAX LABS INC

* IMPAX LABORATORIES INC

ACITRETIN, ACITRETIN

BUDESONIDE, BUDESONIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DEXEDRINE, DEXTROAMPHETAMINE SULFATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

EMVERM, MEBENDAZOLE

EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HYDROCORTISONE, HYDROCORTISONE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 111

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* IMPAX LABORATORIES INC

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RYTARY, CARBIDOPA

IMPAX PHARMS

* IMPAX PHARMACEUTICALS

GEMFIBROZIL, GEMFIBROZIL

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

IMPEL PHARMS

* IMPEL PHARMACEUTICALS INC

TRUDHESA, DIHYDROERGOTAMINE MESYLATE

IMS LTD

* INTERNATIONAL MEDICATION SYSTEMS LTD

REGADENOSON, REGADENOSON

INCYTE CORP

* INCYTE CORP

JAKAFI, RUXOLITINIB PHOSPHATE

OPZELURA, RUXOLITINIB PHOSPHATE

PEMAZYRE, PEMIGATINIB

INDCHEMIE HEALTH

* INDCHEMIE HEALTH SPECIALTIES PVT LTD

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

INDICUS PHARMA

* INDICUS PHARMA LLC

ACETAZOLAMIDE, ACETAZOLAMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

INDIVIOR

* INDIVIOR INC

OPVEE, NALMEFENE HYDROCHLORIDE

PERSERIS KIT, RISPERIDONE

SUBLOCADE, BUPRENORPHINE

SUBOXONE, BUPRENORPHINE HYDROCHLORIDE

INDOCO

* INDOCO REMEDIES LTD

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR, ACYCLOVIR

ALLOPURINOL, ALLOPURINOL

APIXABAN, APIXABAN

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

FEBUXOSTAT, FEBUXOSTAT

GLYCOPYRROLATE, GLYCOPYRROLATE

LACOSAMIDE, LACOSAMIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

OLANZAPINE, OLANZAPINE

RASAGILINE MESYLATE, RASAGILINE MESYLATE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

INDOCO REMEDIES

* INDOCO REMEDIES LTD

GLIMEPIRIDE, GLIMEPIRIDE

INFORLIFE

* INFORLIFE SA

ACETAMINOPHEN, ACETAMINOPHEN

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 112

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* INFORLIFE SA

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN

METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE

MIDAZOLAM IN 0.9% SODIUM CHLORIDE, MIDAZOLAM

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE, NOREPINEPHRINE BITARTRATE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

INGENUS PHARMS LLC

* INGENUS PHARMACEUTICALS LLC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

CABERGOLINE, CABERGOLINE

CARMUSTINE, CARMUSTINE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

TIMOLOL MALEATE, TIMOLOL MALEATE

INNOCOLL

* INNOCOLL PHARMACEUTICALS LTD

POSIMIR, BUPIVACAINE

INNOCOLL PHARMS

* INNOCOLL PHARMACEUTICALS

XARACOLL, BUPIVACAINE HYDROCHLORIDE

INNOGENIX

* INNOGENIX LLC

BACLOFEN, BACLOFEN

HALOPERIDOL, HALOPERIDOL

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

METOLAZONE, METOLAZONE

METRONIDAZOLE, METRONIDAZOLE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

RAMELTEON, RAMELTEON

INNOPHARMA

* INNOPHARMA LICENSING LLC A SUB OF PFIZER INC

PROPOFOL, PROPOFOL

INSMED INC

* INSMED INC

ARIKAYCE KIT, AMIKACIN SULFATE

INTAS PHARMS USA

* INTAS PHARMACEUTICALS USA

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

INTELLIPHARMACEUTICS

* INTELLIPHARMACEUTICS CORP

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

INTERCEPT PHARMS INC

* INTERCEPT PHARMACEUTICALS INC

OCALIVA, OBETICHOLIC ACID

INTERSECT ENT INC

* INTERSECT ENT INC

SINUVA, MOMETASONE FUROATE

INTL ISOTOPES

* INTERNATIONAL ISOTOPES INC

SODIUM IODIDE I 131, SODIUM IODIDE I-131

INTL MEDICATION

* INTERNATIONAL MEDICATION SYSTEM

LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

PHYTONADIONE, PHYTONADIONE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 113

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* INTERNATIONAL MEDICATION SYSTEM

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

INTL MEDICATION SYS

* INTERNATIONAL MEDICATION SYSTEMS LTD

ATROPINE SULFATE, ATROPINE SULFATE

CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE

DEXTROSE 50%, DEXTROSE

EPINEPHRINE, EPINEPHRINE

LORAZEPAM, LORAZEPAM

MORPHINE SULFATE, MORPHINE SULFATE

SODIUM BICARBONATE, SODIUM BICARBONATE

INTRA-CELLULAR

* INTRA-CELLULAR THERAPIES INC

CAPLYTA, LUMATEPERONE TOSYLATE

INVAGEN PHARMS

* INVAGEN PHARMACEUTICALS INC

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CALCIUM ACETATE, CALCIUM ACETATE

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GABAPENTIN, GABAPENTIN

GEMFIBROZIL, GEMFIBROZIL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LANREOTIDE ACETATE, LANREOTIDE ACETATE

LANTHANUM CARBONATE, LANTHANUM CARBONATE

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION, LEUPROLIDE ACETATE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEPROBAMATE, MEPROBAMATE

NABUMETONE, NABUMETONE

NADOLOL, NADOLOL

NAPROXEN, NAPROXEN

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PENICILLAMINE, PENICILLAMINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PREGABALIN, PREGABALIN

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SIMVASTATIN, SIMVASTATIN

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

VIGABATRIN, VIGABATRIN

VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZOLMITRIPTAN, ZOLMITRIPTAN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

ZONISAMIDE, ZONISAMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 114

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

INVATECH

* INVATECH PHARMA SOLUTIONS LLC

DIVALPROEX SODIUM, DIVALPROEX SODIUM

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

INVENTIA

* INVENTIA HEALTHCARE LTD

CHLORTHALIDONE, CHLORTHALIDONE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

LANSOPRAZOLE, LANSOPRAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

PALIPERIDONE, PALIPERIDONE

TELMISARTAN, TELMISARTAN

INVENTIA HLTHCARE

* INVENTIA HEALTHCARE PRIVATE LTD

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

IONETIX

* IONETIX CORP

AMMONIA N 13, AMMONIA N-13

IONIS PHARMS INC

* IONIS PHARMACEUTICALS INC

WAINUA, EPLONTERSEN SODIUM

IPCA LABS LTD

* IPCA LABORATORIES LTD

ALLOPURINOL, ALLOPURINOL

ATENOLOL, ATENOLOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

ESZOPICLONE, ESZOPICLONE

FUROSEMIDE, FUROSEMIDE

GABAPENTIN, GABAPENTIN

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

IPR

* IPR PHARMACEUTICALS INC

CRESTOR, ROSUVASTATIN CALCIUM

IPSEN INC

* IPSEN BIOPHARMACEUTICALS INC

ONIVYDE, IRINOTECAN HYDROCHLORIDE

SOHONOS, PALOVAROTENE

IPSEN PHARMA

* IPSEN PHARMA BIOTECH SAS

SOMATULINE DEPOT, LANREOTIDE ACETATE

IRONSHORE PHARMS

* IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC

JORNAY PM, METHYLPHENIDATE HYDROCHLORIDE

ISOLOGIC INNOVATIVE

* ISOLOGIC INNOVATIVE RADIOPHARMACEUTICALS LTD

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

ISOTEX
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 115

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** I **

* ISOTEX DIAGNOSTICS

GLOFIL-125, IOTHALAMATE SODIUM I-125

ISTITUTO BIO ITA SPA

* ISTITUTO BIOCHIMICO ITALIANO SPA

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PIPERACILLIN, PIPERACILLIN SODIUM

ITALFARMACO SA

* ITALFARMACO SA

TIGLUTIK KIT, RILUZOLE

IVAX SUB TEVA PHARMS

* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

BACLOFEN, BACLOFEN

CABERGOLINE, CABERGOLINE

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOZAPINE, CLOZAPINE

CYCLOSPORINE, CYCLOSPORINE

DIAZEPAM, DIAZEPAM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FAMOTIDINE, FAMOTIDINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

IVERIC BIO

* IVERIC BIO INC

IZERVAY, AVACINCAPTAD PEGOL SODIUM

** J **

HENGRUI PHARMA

* JIANGSU HENGRUI PHARMACEUTICALS CO LTD

CARMUSTINE, CARMUSTINE

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DAPTOMYCIN, DAPTOMYCIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

GADOBUTROL, GADOBUTROL

GADOTERATE MEGLUMINE, GADOTERATE MEGLUMINE

IODIXANOL, IODIXANOL

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

THIOTEPA, THIOTEPA

J AND J CONSUMER INC

* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV

CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)

CHILDREN'S MOTRIN, IBUPROFEN (OTC)

CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)

IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)

JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)

MOTRIN IB, IBUPROFEN (OTC)

PEPCID AC, FAMOTIDINE (OTC)

PEPCID COMPLETE, CALCIUM CARBONATE (OTC)

RHINOCORT ALLERGY, BUDESONIDE (OTC)

SINE-AID IB, IBUPROFEN (OTC)
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 116

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **

* JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV

SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

TYLENOL, ACETAMINOPHEN (OTC)

ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)

JANSSEN BIOTECH

* JANSSEN BIOTECH INC

AKEEGA, ABIRATERONE ACETATE

BALVERSA, ERDAFITINIB

ERLEADA, APALUTAMIDE

ZYTIGA, ABIRATERONE ACETATE

JANSSEN PHARMS

* JANSSEN PHARMACEUTICALS INC

CONCERTA, METHYLPHENIDATE HYDROCHLORIDE

ELMIRON, PENTOSAN POLYSULFATE SODIUM

HALDOL, HALOPERIDOL DECANOATE

INVEGA HAFYERA, PALIPERIDONE PALMITATE

INVEGA SUSTENNA, PALIPERIDONE PALMITATE

INVEGA TRINZA, PALIPERIDONE PALMITATE

INVEGA, PALIPERIDONE

INVOKAMET XR, CANAGLIFLOZIN

INVOKAMET, CANAGLIFLOZIN

INVOKANA, CANAGLIFLOZIN

PONVORY, PONESIMOD

RISPERDAL CONSTA, RISPERIDONE

RISPERDAL, RISPERIDONE

SPORANOX, ITRACONAZOLE

SPRAVATO, ESKETAMINE HYDROCHLORIDE

TOPAMAX, TOPIRAMATE

XARELTO, RIVAROXABAN

JANSSEN PRODS

* JANSSEN PRODUCTS LP

EDURANT, RILPIVIRINE HYDROCHLORIDE

PREZCOBIX, COBICISTAT

PREZISTA, DARUNAVIR

SYMTUZA, COBICISTAT

YONDELIS, TRABECTEDIN

JANSSEN R AND D

* JANSSEN RESEARCH AND DEVELOPMENT LLC

INTELENCE, ETRAVIRINE

JANSSEN THERAP

* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

SIRTURO, BEDAQUILINE FUMARATE

JAZZ

* JAZZ PHARMACEUTICALS IRELAND LTD

XYWAV, CALCIUM OXYBATE

ZEPZELCA, LURBINECTEDIN

JAZZ PHARMS

* JAZZ PHARMACEUTICALS INC

XYREM, SODIUM OXYBATE

JAZZ PHARMS INC

* JAZZ PHARMACEUTICALS INC

DEFITELIO, DEFIBROTIDE SODIUM

JAZZ PHARMS RES

* JAZZ PHARMACEUTICALS RESEARCH UK LTD

EPIDIOLEX, CANNABIDIOL

JDP

* JDP THERAPEUTICS LLC

QUZYTTIR, CETIRIZINE HYDROCHLORIDE

JIANGSU HANSOH PHARM

* JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD

AZACITIDINE, AZACITIDINE

BORTEZOMIB, BORTEZOMIB

DECITABINE, DECITABINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 117

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **

* JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD

FULVESTRANT, FULVESTRANT

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

ICATIBANT ACETATE, ICATIBANT ACETATE

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

PEMETREXED DISODIUM, PEMETREXED DISODIUM

VINORELBINE TARTRATE, VINORELBINE TARTRATE

JOHNS HOPKINS UNIV

* JOHNS HOPKINS UNIV

AMMONIA N 13, AMMONIA N-13

JOHNSON AND JOHNSON

* JOHNSON AND JOHNSON CONSUMER INC

VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)

VISINE, NAPHAZOLINE HYDROCHLORIDE (OTC)

* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES

MEN'S ROGAINE, MINOXIDIL (OTC)

ROGAINE (FOR MEN), MINOXIDIL (OTC)

ROGAINE (FOR WOMEN), MINOXIDIL (OTC)

ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

WOMEN'S ROGAINE, MINOXIDIL (OTC)

JOURNEY

* JOURNEY MEDICAL CORP

AMZEEQ, MINOCYCLINE HYDROCHLORIDE

EURAX, CROTAMITON

EXELDERM, SULCONAZOLE NITRATE

QBREXZA, GLYCOPYRRONIUM TOSYLATE

ZILXI, MINOCYCLINE HYDROCHLORIDE

JUBILANT

* JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA

DRAX EXAMETAZIME, TECHNETIUM TC-99M EXAMETAZIME KIT

DRAXIMAGE DTPA, TECHNETIUM TC-99M PENTETATE KIT

DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE

HICON, SODIUM IODIDE I-131

RUBY-FILL, RUBIDIUM CHLORIDE RB-82

SODIUM IODIDE I 131, SODIUM IODIDE I-131

TECHNETIUM TC-99M SULFUR COLLOID KIT, TECHNETIUM TC-99M SULFUR COLLOID KIT

JUBILANT CADISTA

* JUBILANT CADISTA PHARMACEUTICALS INC

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LAMOTRIGINE, LAMOTRIGINE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

PREDNISONE, PREDNISONE

PROCOMP, PROCHLORPERAZINE MALEATE

TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE

JUBILANT DRAXIMAGE

* JUBILANT DRAXIMAGE INC

TECHNETIUM TC 99M MERTIATIDE KIT, TECHNETIUM TC-99M MERTIATIDE KIT

* JUBILANT DRAXIMAGE RADIOPHARMACIES INC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

* JUBILANT DRAXIMAGE USA INC

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

JUBILANT GENERICS

* JUBILANT GENERICS LTD

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 118

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** J **

* JUBILANT GENERICS LTD

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

IRBESARTAN, IRBESARTAN

OLANZAPINE, OLANZAPINE

RISPERIDONE, RISPERIDONE

SPIRONOLACTONE, SPIRONOLACTONE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN, VALSARTAN

ZOLMITRIPTAN, ZOLMITRIPTAN

STEVENS J

* JEROME STEVENS PHARMACEUTICALS INC

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

DIGOXIN, DIGOXIN

UNITHROID, LEVOTHYROXINE SODIUM **

** K **

GRIFFEN

* KW GRIFFEN CO

BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)

KADMON PHARMS LLC

* KADMON PHARMACEUTICALS LLC

REZUROCK, BELUMOSUDIL MESYLATE

KAI PHARMS INC

* KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC

PARSABIV, ETELCALCETIDE

KALEO INC

* KALEO INC

AUVI-Q, EPINEPHRINE

KARYOPHARM THERAPS

* KARYOPHARM THERAPEUTICS INC

XPOVIO, SELINEXOR

KENTON

* KENTON CHEMICALS AND PHARMACEUTICALS CORP

ANASTROZOLE, ANASTROZOLE

CAPTOPRIL, CAPTOPRIL

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

RILUZOLE, RILUZOLE

KERYX BIOPHARMS

* KERYX BIOPHARMACEUTICALS INC

AURYXIA, FERRIC CITRATE

KETTERING MEDCTR

* KETTERING MEDCTR

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

KINDEVA

* KINDEVA DRUG DELIVERY LP

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-75, FENTANYL

PROVENTIL-HFA, ALBUTEROL SULFATE

KINDOS

* KINDOS PHARMACEUTICALS CO LTD

BENDAMUSTINE HYDROCHLORIDE, BENDAMUSTINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

NELARABINE, NELARABINE

PLERIXAFOR, PLERIXAFOR

THIOTEPA, THIOTEPA

KING PHARMS

* KING PHARMACEUTICALS INC

SYNERCID, DALFOPRISTIN

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 119

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** K **

* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC

CYTOMEL, LIOTHYRONINE SODIUM

LEVOXYL, LEVOTHYROXINE SODIUM **

KING PHARMS LLC

* KING PHARMACEUTICALS LLC

ALTACE, RAMIPRIL

BICILLIN C-R 900/300, PENICILLIN G BENZATHINE

BICILLIN C-R, PENICILLIN G BENZATHINE

BICILLIN L-A, PENICILLIN G BENZATHINE

PENICILLIN G PROCAINE, PENICILLIN G PROCAINE

SILVADENE, SILVER SULFADIAZINE

KNACK

* KNACK PHARMACEUTICALS INC

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

KNIGHT THERAPS

* KNIGHT THERAPEUTICS USA INC

IMPAVIDO, MILTEFOSINE

KOWA CO

* KOWA CO LTD

LIVALO, PITAVASTATIN CALCIUM

KOWA PHARMS

* KOWA PHARMACEUTICALS AMERICA INC

SEGLENTIS, CELECOXIB

KRAMER

* KRAMER LABORATORIES INC

NIZORAL ANTI-DANDRUFF, KETOCONAZOLE (OTC)

KREITCHMAN PET CTR

* KREITCHMAN PET CENTER

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

KVK TECH

* KVK TECH INC

BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

KALEXATE, SODIUM POLYSTYRENE SULFONATE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

KVK TECH INC

* KVK TECH INC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

KYOWA KIRIN

* KYOWA KIRIN INC

FARESTON, TOREMIFENE CITRATE

NOURIANZ, ISTRADEFYLLINE

KYTHERA BIOPHARMS

* KYTHERA BIOPHARMACEUTICALS INC

KYBELLA, DEOXYCHOLIC ACID

** L **

L PERRIGO CO

* L PERRIGO CO

ACETAMINOPHEN AND IBUPROFEN, ACETAMINOPHEN (OTC)

CIMETIDINE, CIMETIDINE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE (OTC)

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 120

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* L PERRIGO CO

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

LA JOLLA PHARMA

* LA JOLLA PHARMA LLC

GIAPREZA, ANGIOTENSIN II ACETATE

LAB HRA PHARMA

* LABORATOIRE HRA PHARMA

ELLA, ULIPRISTAL ACETATE

LABORATOIRE HRA

* LABORATOIRE HRA PHARMA

LEVONORGESTREL, LEVONORGESTREL (OTC)

LABORATORIOS GRIFOLS

* LABORATORIOS GRIFOLS SA

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

LABORATORIOS SALVAT

* LABORATORIOS SALVAT SA

OTOVEL, CIPROFLOXACIN HYDROCHLORIDE

LABS JUVISE

* LABORATOIRES JUVISE PHARMACEUTICALS

PYLERA, BISMUTH SUBCITRATE POTASSIUM

LACER PHARMA

* LACER PHARMA LLC

ERTACZO, SERTACONAZOLE NITRATE

LANDELA PHARM

* LANDELA PHARMACEUTICAL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

LANNETT

* LANNETT CO INC

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

LANORINAL, ASPIRIN

PRIMIDONE, PRIMIDONE

PROBALAN, PROBENECID

LANNETT CO INC

* LANNETT CO INC

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BACLOFEN, BACLOFEN

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CODEINE SULFATE, CODEINE SULFATE

DANAZOL, DANAZOL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

LACTULOSE, LACTULOSE

LEVOFLOXACIN, LEVOFLOXACIN

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LOPINAVIR AND RITONAVIR, LOPINAVIR

LORATADINE, LORATADINE (OTC)

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

METAXALONE, METAXALONE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 121

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LANNETT CO INC

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NIACIN, NIACIN

OMEPRAZOLE, OMEPRAZOLE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISOLONE, PREDNISOLONE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SUMATRIPTAN, SUMATRIPTAN

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

URSODIOL, URSODIOL

LANTHEUS MEDCL

* LANTHEUS MEDICAL IMAGING INC

CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT

DEFINITY RT, PERFLUTREN

DEFINITY, PERFLUTREN

NEUROLITE, TECHNETIUM TC-99M BICISATE KIT

TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

XENON XE 133, XENON XE-133

LARKEN LABS

* LARKEN LABORATORIES INC

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

OFLOXACIN, OFLOXACIN

LARKEN LABS INC

* LARKEN LABORATORIES INC

ALLZITAL, ACETAMINOPHEN

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

DEXAMETHASONE, DEXAMETHASONE

LAURUS

* LAURUS LABS LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

GABAPENTIN, GABAPENTIN

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

LOPINAVIR AND RITONAVIR, LOPINAVIR

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIRFENIDONE, PIRFENIDONE

LAVIPHARM

* LAVIPHARM SA

CATAPRES-TTS-1, CLONIDINE

CATAPRES-TTS-2, CLONIDINE

CATAPRES-TTS-3, CLONIDINE

LEADIANT BIOSCI INC

* LEADIANT BIOSCIENCES INC

ABELCET, AMPHOTERICIN B

CARNITOR SF, LEVOCARNITINE

CARNITOR, LEVOCARNITINE

CYSTARAN, CYSTEAMINE HYDROCHLORIDE

MATULANE, PROCARBAZINE HYDROCHLORIDE

LEADING

* LEADING PHARMA LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

FOLIC ACID, FOLIC ACID
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 122

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LEADING PHARMA LLC

FUROSEMIDE, FUROSEMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROXYUREA, HYDROXYUREA

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LORAZEPAM, LORAZEPAM

NIFEDIPINE, NIFEDIPINE

NYSTATIN, NYSTATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

THEOPHYLLINE, THEOPHYLLINE

LEADING PHARMA

* LEADING PHARMA LLC

LACOSAMIDE, LACOSAMIDE

VARENICLINE TARTRATE, VARENICLINE TARTRATE

LEGACY PHARMA

* LEGACY PHARMA INC

ALA-SCALP, HYDROCORTISONE

BETAPACE AF, SOTALOL HYDROCHLORIDE

BETAPACE, SOTALOL HYDROCHLORIDE

CROTAN, CROTAMITON

LEGACY PHARMA USA

* LEGACY PHARMA USA INC

ZANAFLEX, TIZANIDINE HYDROCHLORIDE

LEO PHARMA AS

* LEO PHARMA AS

DOVONEX, CALCIPOTRIENE

ENSTILAR, BETAMETHASONE DIPROPIONATE

FINACEA, AZELAIC ACID

PROTOPIC, TACROLIMUS

TACLONEX, BETAMETHASONE DIPROPIONATE

LEXICON PHARMS INC

* LEXICON PHARMACEUTICALS INC

INPEFA, SOTAGLIFLOZIN

LGM PHARMA

* LGM PHARMA SOLUTIONS LLC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN

CHENODIOL, CHENODIOL

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCODONE BITARTRATE AND ASPIRIN, ASPIRIN

MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE

NABUMETONE, NABUMETONE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

URSODIOL, URSODIOL

LIEBEL-FLARSHEIM

* LIEBEL-FLARSHEIM CO LLC

CONRAY, IOTHALAMATE MEGLUMINE

CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE

MD-GASTROVIEW, DIATRIZOATE MEGLUMINE

OPTIRAY 300, IOVERSOL

OPTIRAY 320, IOVERSOL

OPTIRAY 350, IOVERSOL

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

LIFE MOLECULAR

* LIFE MOLECULAR IMAGING LTD

NEURACEQ, FLORBETABEN F-18

LINDE GAS EQUIP

* LINDE GAS AND EQUIPMENT INC

NOXIVENT, NITRIC OXIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 123

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

LNHC

* LNHC INC

SITAVIG, ACYCLOVIR

LNK

* LNK INTERNATIONAL INC

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LNK INTL INC

* LNK INTERNATIONAL INC

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

LONG GROVE PHARMS

* LONG GROVE PHARMACEUTICALS LLC

AK-FLUOR 10%, FLUORESCEIN SODIUM

AK-FLUOR 25%, FLUORESCEIN SODIUM

CALCITRIOL, CALCITRIOL

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

LOREAL USA

* LOREAL USA PRODUCTS INC

ANTHELIOS 20, AVOBENZONE (OTC)

ANTHELIOS 40, AVOBENZONE (OTC)

ANTHELIOS SX, AVOBENZONE (OTC)

CAPITAL SOLEIL 15, AVOBENZONE (OTC)

LOTUS PHARM CO LTD

* LOTUS PHARMACEUTICAL CO LTD NANTOU PLANT

LENALIDOMIDE, LENALIDOMIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

LOXO ONCOL

* LOXO ONCOLOGY INC

JAYPIRCA, PIRTOBRUTINIB

LOXO ONCOL ELI LILLY

* LOXO ONCOLOGY INC A WHOLLY OWNED SUB OF ELI LILLY AND CO

RETEVMO, SELPERCATINIB

LUITPOLD

* LUITPOLD PHARMACEUTICALS INC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

LUKARE MEDICAL LLC

* LUKARE MEDICAL LLC

ELLIOTTS B SOLUTION, CALCIUM CHLORIDE

LUNDBECK NA LTD

* LUNDBECK NA LTD

NORTHERA, DROXIDOPA

LUNDBECK PHARMS LLC

* LUNDBECK PHARMACEUTICALS LLC

ONFI, CLOBAZAM

SABRIL, VIGABATRIN

LUOXIN AUROVITAS

* LUOXIN AUROVITAS PHARMA CHENGDU CO LTD

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LUPIN

* LUPIN INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ANTARA (MICRONIZED), FENOFIBRATE

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

BROVANA, ARFORMOTEROL TARTRATE

BUDESONIDE, BUDESONIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CYANOCOBALAMIN, CYANOCOBALAMIN

DESOXIMETASONE, DESOXIMETASONE

DIMETHYL FUMARATE, DIMETHYL FUMARATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 124

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUPIN INC

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FORMOTEROL FUMARATE, FORMOTEROL FUMARATE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

MIBELAS 24 FE, ETHINYL ESTRADIOL

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NYSTATIN, NYSTATIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SOLOSEC, SECNIDAZOLE

TESTOSTERONE, TESTOSTERONE

TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE

TOBRAMYCIN, TOBRAMYCIN

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

XOPENEX HFA, LEVALBUTEROL TARTRATE

* LUPIN LTD

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CARVEDILOL, CARVEDILOL

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CEFPROZIL, CEFPROZIL

CEFUROXIME AXETIL, CEFUROXIME AXETIL

CEPHALEXIN, CEPHALEXIN

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOVASTATIN, LOVASTATIN

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

TRANDOLAPRIL, TRANDOLAPRIL

LUPIN LTD

* LUPIN LIMITED

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

* LUPIN LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE

ALLOPURINOL, ALLOPURINOL

AMABELZ, ESTRADIOL

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

ARMODAFINIL, ARMODAFINIL

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATOVAQUONE, ATOVAQUONE

AZITHROMYCIN, AZITHROMYCIN

BEKYREE, DESOGESTREL

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BIMATOPROST, BIMATOPROST

BLISOVI 24 FE, ETHINYL ESTRADIOL

BLISOVI FE 1.5/30, ETHINYL ESTRADIOL

BLISOVI FE 1/20, ETHINYL ESTRADIOL

BROMFENAC SODIUM, BROMFENAC SODIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CALCIUM ACETATE, CALCIUM ACETATE

CELECOXIB, CELECOXIB

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 125

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUPIN LTD

DARUNAVIR, DARUNAVIR

DAYSEE, ETHINYL ESTRADIOL

DECITABINE, DECITABINE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DOXYCYCLINE, DOXYCYCLINE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, DROSPIRENONE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ENSKYCE, DESOGESTREL

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESZOPICLONE, ESZOPICLONE

ETHACRYNIC ACID, ETHACRYNIC ACID

FALLBACK SOLO, LEVONORGESTREL (OTC)

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE, FENOFIBRATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

FYAVOLV, ETHINYL ESTRADIOL

GANIRELIX ACETATE, GANIRELIX ACETATE

GATIFLOXACIN, GATIFLOXACIN

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

JENCYCLA, NORETHINDRONE

KAITLIB FE, ETHINYL ESTRADIOL

KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE, KETOROLAC TROMETHAMINE

KURVELO, ETHINYL ESTRADIOL

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LAMOTRIGINE, LAMOTRIGINE

LEFLUNOMIDE, LEFLUNOMIDE

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOTEPREDNOL ETABONATE, LOTEPREDNOL ETABONATE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MEFENAMIC ACID, MEFENAMIC ACID

MELOXICAM, MELOXICAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRABEGRON, MIRABEGRON

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

NIACIN, NIACIN

NIKKI, DROSPIRENONE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

PALIPERIDONE, PALIPERIDONE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 126

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* LUPIN LTD

PENICILLAMINE, PENICILLAMINE

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

RANOLAZINE, RANOLAZINE

RIFABUTIN, RIFABUTIN

RUFINAMIDE, RUFINAMIDE

SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

SUPRAX, CEFIXIME

TADALAFIL, TADALAFIL

TAVABOROLE, TAVABOROLE

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TENOFOVIR ALAFENAMIDE, TENOFOVIR ALAFENAMIDE FUMARATE

TESTOSTERONE, TESTOSTERONE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TURQOZ, ETHINYL ESTRADIOL

TYDEMY, DROSPIRENONE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VARENICLINE TARTRATE, VARENICLINE TARTRATE

VYFEMLA, ETHINYL ESTRADIOL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

LUPIN PHARMS

* LUPIN PHARMACEUTICALS INC

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

DESLORATADINE, DESLORATADINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DROXIDOPA, DROXIDOPA

MELOXICAM, MELOXICAM

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

RIFAMPIN, RIFAMPIN

SUPRAX, CEFIXIME

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

LYNE

* LYNE LABORATORIES INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXAMETHASONE, DEXAMETHASONE

ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

LEVOCARNITINE, LEVOCARNITINE

NYSTATIN, NYSTATIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

LYRUS LIFE SCIENCES

* LYRUS LIFE SCIENCES PRIVATE LTD

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

PERRIGO

* L PERRIGO CO

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)

CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)

DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LORATADINE, LORATADINE (OTC)

MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 127

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** L **

* L PERRIGO CO

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

TIOCONAZOLE, TIOCONAZOLE (OTC)

** M **

MA GENERAL HOSP

* MASSACHUSETTS GENERAL HOSP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

MACLEODS PHARMS LTD

* MACLEODS PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CELECOXIB, CELECOXIB

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DARIFENACIN, DARIFENACIN HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ENTACAPONE, ENTACAPONE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESZOPICLONE, ESZOPICLONE

FAMCICLOVIR, FAMCICLOVIR

FEBUXOSTAT, FEBUXOSTAT

FLUOCINONIDE, FLUOCINONIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LIDOCAINE, LIDOCAINE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NEVIRAPINE, NEVIRAPINE

NIACIN, NIACIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

PYRAZINAMIDE, PYRAZINAMIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

REPAGLINIDE, REPAGLINIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 128

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MACLEODS PHARMACEUTICALS LTD

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SEVELAMER HYDROCHLORIDE, SEVELAMER HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

TADALAFIL, TADALAFIL

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

MAIA PHARMS INC

* MAIA PHARMACEUTICALS INC

ANGIOMAX RTU, BIVALIRUDIN

BACLOFEN, BACLOFEN

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

SINCALIDE, SINCALIDE

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

MAINPOINTE

* MAINPOINTE PHARMACEUTICALS LLC

TUXARIN ER, CHLORPHENIRAMINE MALEATE

MALLINCKRODT ARD

* MALLINCKRODT ARD INC

ACTHAR GEL, CORTICOTROPIN

MALLINCKRODT HOSP

* MALLINCKRODT HOSP PRODUCTS IP LTD

INOMAX, NITRIC OXIDE

UVADEX, METHOXSALEN

MALLINCKRODT IRELAND

* MALLINCKRODT PHARMACEUTICALS IRELAND LTD

TERLIVAZ, TERLIPRESSIN ACETATE

MANKIND PHARMA

* MANKIND PHARMA LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

ATROPINE SULFATE, ATROPINE SULFATE

BACLOFEN, BACLOFEN

CHLORTHALIDONE, CHLORTHALIDONE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

EPHEDRINE SULFATE, EPHEDRINE SULFATE

FAMOTIDINE, FAMOTIDINE

FENOFIBRATE, FENOFIBRATE

FORMOTEROL FUMARATE, FORMOTEROL FUMARATE

FUROSEMIDE, FUROSEMIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NITROGLYCERIN, NITROGLYCERIN

OFLOXACIN, OFLOXACIN

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

RANOLAZINE, RANOLAZINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 129

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MANKIND PHARMA LTD

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN, TOBRAMYCIN

VARENICLINE TARTRATE, VARENICLINE TARTRATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

MARINUS

* MARINUS PHARMACEUTICALS INC

ZTALMY, GANAXOLONE

MARIUS PHARMS LLC

* MARIUS PHARMACEUTICALS LLC

KYZATREX, TESTOSTERONE UNDECANOATE

MARKSANS PHARMA

* MARKSANS PHARMA LTD

ACETAMINOPHEN AND IBUPROFEN, ACETAMINOPHEN (OTC)

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

LORATADINE, LORATADINE (OTC)

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NAPROXEN, NAPROXEN

PARICALCITOL, PARICALCITOL

MAYNE PHARMA

* MAYNE PHARMA INTERNATIONAL PTY LTD

DORYX MPC, DOXYCYCLINE HYCLATE

DORYX, DOXYCYCLINE HYCLATE

TOLSURA, ITRACONAZOLE

* MAYNE PHARMA LLC

ANNOVERA, ETHINYL ESTRADIOL

BIJUVA, ESTRADIOL

FABIOR, TAZAROTENE

IMVEXXY, ESTRADIOL

LEXETTE, HALOBETASOL PROPIONATE

NEXTSTELLIS, DROSPIRENONE

RHOFADE, OXYMETAZOLINE HYDROCHLORIDE

SORILUX, CALCIPOTRIENE

MAYNE PHARMA COMMRCL

* MAYNE PHARMA COMMERCIAL LLC

SOLTAMOX, TAMOXIFEN CITRATE

MC2

* MC2 THERAPEUTICS LTD

WYNZORA, BETAMETHASONE DIPROPIONATE

MCGUFF

* MCGUFF PHARMACEUTICALS INC

ASCOR, ASCORBIC ACID

MCNEIL

* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC

IBUPROFEN, IBUPROFEN (OTC)

MCPRF

* MAYO CLINIC PET RADIOCHEMISTRY FACILITY

AMMONIA N 13, AMMONIA N-13

CHOLINE C-11, CHOLINE C-11

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MDD US

* MDD US OPERATIONS LLC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 130

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MDD US OPERATIONS LLC

APOKYN, APOMORPHINE HYDROCHLORIDE

XADAGO, SAFINAMIDE MESYLATE

MDGH

* MEDICINES DEVELOPMENT FOR GLOBAL HEALTH

MOXIDECTIN, MOXIDECTIN

MEDEFIL INC

* MEDEFIL INC

ATROPINE SULFATE, ATROPINE SULFATE

CALCIUM CHLORIDE 10%, CALCIUM CHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

MEDEXUS

* MEDEXUS PHARMA INC

RASUVO, METHOTREXATE

MEDI-RADIOPHARMA

* MEDI-RADIOPHARMA LTD

TECHNETIUM TC99M MERTIATIDE KIT, TECHNETIUM TC-99M MERTIATIDE KIT

MEDICINES360

* MEDICINES360

LILETTA, LEVONORGESTREL

MEDICURE

* MEDICURE INTERNATIONAL INC

AGGRASTAT, TIROFIBAN HYDROCHLORIDE

ZYPITAMAG, PITAVASTATIN MAGNESIUM

MEDIMETRIKS PHARMS

* MEDIMETRIKS PHARMACEUTICALS INC

BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE

LOPROX, CICLOPIROX

NEO-SYNALAR, FLUOCINOLONE ACETONIDE

SYNALAR, FLUOCINOLONE ACETONIDE

MEDLINE INDUSTRIES

* MEDLINE INDUSTRIES INC

READYPREP CHG, CHLORHEXIDINE GLUCONATE (OTC)

MEDTECH PRODUCTS

* MEDTECH PRODUCTS INC

MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)

MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 3, MICONAZOLE NITRATE

MONISTAT 3, MICONAZOLE NITRATE (OTC)

MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MONISTAT 7, MICONAZOLE NITRATE (OTC)

NIX, PERMETHRIN (OTC)

TAGAMET HB, CIMETIDINE (OTC)

MEDUNIK

* MEDUNIK CANADA INC

NITISINONE, NITISINONE

PHEBURANE, SODIUM PHENYLBUTYRATE

MEITHEAL

* MEITHEAL PHARMACEUTICALS INC

ADENOSINE, ADENOSINE

ALPROSTADIL, ALPROSTADIL

AMIKACIN SULFATE, AMIKACIN SULFATE

ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE

ATRACURIUM BESYLATE, ATRACURIUM BESYLATE

AZACITIDINE, AZACITIDINE

BIVALIRUDIN, BIVALIRUDIN

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BORTEZOMIB, BORTEZOMIB

BUSULFAN, BUSULFAN

CARMUSTINE, CARMUSTINE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CLOFARABINE, CLOFARABINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 131

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MEITHEAL PHARMACEUTICALS INC

CYTARABINE, CYTARABINE

DACARBAZINE, DACARBAZINE

DACTINOMYCIN, DACTINOMYCIN

DAPTOMYCIN, DAPTOMYCIN

DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

DOXERCALCIFEROL, DOXERCALCIFEROL

ETOPOSIDE, ETOPOSIDE

FUROSEMIDE, FUROSEMIDE

GANIRELIX ACETATE, GANIRELIX ACETATE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE

IFOSFAMIDE, IFOSFAMIDE

ISOSULFAN BLUE, ISOSULFAN BLUE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

MILRINONE LACTATE, MILRINONE LACTATE

MITOMYCIN, MITOMYCIN

MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

REGADENOSON, REGADENOSON

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TIGECYCLINE, TIGECYCLINE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VORICONAZOLE, VORICONAZOLE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

MELINTA

* MELINTA SUBSIDIARY CORP

BAXDELA, DELAFLOXACIN MEGLUMINE

MELINTA THERAP

* MELINTA THERAPEUTICS LLC

KIMYRSA, ORITAVANCIN DIPHOSPHATE

ORBACTIV, ORITAVANCIN DIPHOSPHATE

MEM SLOAN-KETTERING

* MEMORIAL SLOAN-KETTERING CANCER CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

MERCK

* MERCK AND CO INC

CANCIDAS, CASPOFUNGIN ACETATE

EMEND, APREPITANT

PRIMAXIN, CILASTATIN SODIUM

MERCK AND CO INC

* MERCK AND CO INC

EMEND, FOSAPREPITANT DIMEGLUMINE

MERCK SHARP DOHME

* MERCK SHARP AND DOHME CORP
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 132

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MERCK SHARP AND DOHME CORP

BELSOMRA, SUVOREXANT

JANUVIA, SITAGLIPTIN PHOSPHATE

NOXAFIL, POSACONAZOLE

PREVYMIS, LETERMOVIR

STROMECTOL, IVERMECTIN

TEMODAR, TEMOZOLOMIDE

VERQUVO, VERICIGUAT

* MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

WELIREG, BELZUTIFAN

MERIDIAN BIOSCIENCE

* MERIDIAN BIOSCIENCE ISRAEL LTD

IDKIT:HP, CITRIC ACID

MERRO PHARM USA

* MERRO PHARMACEUTICAL USA INC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

MERZ PHARMS

* MERZ PHARMACEUTICALS LLC

CUVPOSA, GLYCOPYRROLATE

METACEL PHARMS LLC

* METACEL PHARMACEUTICALS LLC

OZOBAX DS, BACLOFEN

METHAPHARM

* METHAPHARM INC

PROVOCHOLINE, METHACHOLINE CHLORIDE

METUCHEN PHARMS

* METUCHEN PHARMACEUTICALS LLC

STENDRA, AVANAFIL

MICRO LABS

* MICRO LABS LTD

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

BACLOFEN, BACLOFEN

BIMATOPROST, BIMATOPROST

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CELECOXIB, CELECOXIB

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CROMOLYN SODIUM, CROMOLYN SODIUM

DALFAMPRIDINE, DALFAMPRIDINE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ERYTHRA-DERM, ERYTHROMYCIN

FAMOTIDINE, FAMOTIDINE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLIMEPIRIDE, GLIMEPIRIDE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

LIFITEGRAST, LIFITEGRAST

LINCOMYCIN HYDROCHLORIDE, LINCOMYCIN HYDROCHLORIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEFENAMIC ACID, MEFENAMIC ACID
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 133

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MICRO LABS LTD

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MISOPROSTOL, MISOPROSTOL

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

PIRFENIDONE, PIRFENIDONE

PIROXICAM, PIROXICAM

RAMELTEON, RAMELTEON

RANOLAZINE, RANOLAZINE

RASAGILINE MESYLATE, RASAGILINE MESYLATE

ROFLUMILAST, ROFLUMILAST

RUFINAMIDE, RUFINAMIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SIMVASTATIN, SIMVASTATIN

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TAFLUPROST, TAFLUPROST

TELMISARTAN, TELMISARTAN

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRAMYCIN, TOBRAMYCIN

TRANEXAMIC ACID, TRANEXAMIC ACID

TRAVOPROST, TRAVOPROST

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

MICRO LABS LTD

* MICRO LABS LTD

NEVIRAPINE, NEVIRAPINE

MICRO LABS LTD INDIA

* MICRO LABS LTD INDIA

ACETAZOLAMIDE, ACETAZOLAMIDE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

CROMOLYN SODIUM, CROMOLYN SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LEVOFLOXACIN, LEVOFLOXACIN

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

MIDWEST MEDCL

* MIDWEST MEDICAL ISOTOPES LLC CYCLOTRON DIV

AMMONIA N 13, AMMONIA N-13

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MIKART

* MIKART LLC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTAPAP, ACETAMINOPHEN

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

CHLORZOXAZONE, CHLORZOXAZONE

ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE

ETHOSUXIMIDE, ETHOSUXIMIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

METHAZOLAMIDE, METHAZOLAMIDE

METHOCARBAMOL, METHOCARBAMOL

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

MILLA PHARMS

* MILLA PHARMACEUTICALS INC

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

SODIUM ACETATE, SODIUM ACETATE

MILLICENT

* MILLICENT HOLDINGS LTD
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 134

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MILLICENT HOLDINGS LTD

FEMRING, ESTRADIOL ACETATE

* MILLICENT PHARMA LTD

INTRAROSA, PRASTERONE

MIPS CRF

* MIPS CYCLOTRON AND RADIOCHEMISTRY FACILITY

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

MIRATI THERAPS

* MIRATI THERAPEUTICS INC

KRAZATI, ADAGRASIB

MIRUM

* MIRUM PHARMACEUTICALS INC

CHOLBAM, CHOLIC ACID

LIVMARLI, MARALIXIBAT CHLORIDE

MISEMER

* MISEMER PHARMACEUTICALS INC

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

KETOPROFEN, KETOPROFEN

MISSION PHARMA

* MISSION PHARMACAL CO

LITHOSTAT, ACETOHYDROXAMIC ACID

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

TEXACORT, HYDROCORTISONE

THIOLA, TIOPRONIN

TINDAMAX, TINIDAZOLE

UROCIT-K, POTASSIUM CITRATE

MISSION PHARMACAL

* MISSION PHARMACAL CO

CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE

GABAPENTIN, GABAPENTIN

POTASSIUM IODIDE, POTASSIUM IODIDE (OTC)

THIOLA EC, TIOPRONIN

MITSUBISHI TANABE

* MITSUBISHI TANABE PHARMA CORP

RADICAVA ORS, EDARAVONE

RADICAVA, EDARAVONE

MLV

* MLV PHARMA LLC

CARISOPRODOL, CARISOPRODOL

METHOCARBAMOL, METHOCARBAMOL

NYSTATIN, NYSTATIN

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

MMT

* MERIDIAN MEDICAL TECHNOLOGIES LLC

DUODOTE, ATROPINE

SEIZALAM, MIDAZOLAM HYDROCHLORIDE

MOBIUS THERAP

* MOBIUS THERAPEUTICS LLC

MITOSOL, MITOMYCIN

MOLNLYCKE HLTH

* MOLNLYCKE HEALTH CARE

HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)

HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)

MONARCH PHARMS

* MONARCH PHARMACEUTICALS LLC

MENEST, ESTROGENS, ESTERIFIED

NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE

NEOSPORIN, GRAMICIDIN

SEPTRA DS, SULFAMETHOXAZOLE

SEPTRA, SULFAMETHOXAZOLE

VIROPTIC, TRIFLURIDINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 135

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

MONTEREY PHARMS LLC

* MONTEREY PHARMACEUTICALS LLC

METHOCARBAMOL, METHOCARBAMOL

MOUNTAIN

* MOUNTAIN LLC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

METAXALONE, METAXALONE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MSD MERCK CO

* MERCK SHARP AND DOHME CORP A SUB OF MERCK AND CO INC

DELSTRIGO, DORAVIRINE

EMEND, APREPITANT

NOXAFIL POWDERMIX KIT, POSACONAZOLE

PIFELTRO, DORAVIRINE

RECARBRIO, CILASTATIN SODIUM

MSD SUB MERCK

* MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC

BRIDION, SUGAMMADEX SODIUM

INVANZ, ERTAPENEM SODIUM

ISENTRESS HD, RALTEGRAVIR POTASSIUM

ISENTRESS, RALTEGRAVIR POTASSIUM

JANUMET XR, METFORMIN HYDROCHLORIDE

JANUMET, METFORMIN HYDROCHLORIDE

SEGLUROMET, ERTUGLIFLOZIN

STEGLATRO, ERTUGLIFLOZIN

STEGLUJAN, ERTUGLIFLOZIN

ZEPATIER, ELBASVIR

ZOLINZA, VORINOSTAT

MSN

* MSN LABORATORIES PRIVATE LTD

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACYCLOVIR, ACYCLOVIR

ALBENDAZOLE, ALBENDAZOLE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BORTEZOMIB, BORTEZOMIB

BUMETANIDE, BUMETANIDE

CAPECITABINE, CAPECITABINE

CARMUSTINE, CARMUSTINE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CLOBAZAM, CLOBAZAM

CLOFARABINE, CLOFARABINE

DARUNAVIR, DARUNAVIR

DECITABINE, DECITABINE

DEFERASIROX, DEFERASIROX

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DOFETILIDE, DOFETILIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

FEBUXOSTAT, FEBUXOSTAT

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

HALOPERIDOL, HALOPERIDOL

ISOSULFAN BLUE, ISOSULFAN BLUE

LACOSAMIDE, LACOSAMIDE

LEVETIRACETAM, LEVETIRACETAM

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

PACLITAXEL, PACLITAXEL

PIRFENIDONE, PIRFENIDONE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 136

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MSN LABORATORIES PRIVATE LTD

PLERIXAFOR, PLERIXAFOR

PREGABALIN, PREGABALIN

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RIOCIGUAT, RIOCIGUAT

ROFLUMILAST, ROFLUMILAST

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SILODOSIN, SILODOSIN

SIROLIMUS, SIROLIMUS

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TASIMELTEON, TASIMELTEON

TERIFLUNOMIDE, TERIFLUNOMIDE

THIOTEPA, THIOTEPA

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

TOLVAPTAN, TOLVAPTAN

TOREMIFENE CITRATE, TOREMIFENE CITRATE

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VIGABATRIN, VIGABATRIN

ZIPRASIDONE MESYLATE, ZIPRASIDONE MESYLATE

MSN LABS PVT LTD

* MSN LABORATORIES PRIVATE LTD

LACOSAMIDE, LACOSAMIDE

MSN PHARMS INC

* MSN PHARMACEUTICALS INC

DROXIDOPA, DROXIDOPA

MYCOVIA PHARMS

* MYCOVIA PHARMACEUTICALS INC

VIVJOA, OTESECONAZOLE

MYLAN

* MYLAN INSTITUTIONAL LLC A VIATRIS CO

ALOPRIM, ALLOPURINOL SODIUM

* MYLAN LABORATORIES LTD A VIATRIS CO

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

* MYLAN PHARMACEUTICALS

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

* MYLAN PHARMACEUTICALS INC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ACETAMINOPHEN, ACETAMINOPHEN

ACITRETIN, ACITRETIN

ALLOPURINOL, ALLOPURINOL

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

AMBRISENTAN, AMBRISENTAN

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE

BEPOTASTINE BESILATE, BEPOTASTINE BESILATE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BREYNA, BUDESONIDE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BUDESONIDE, BUDESONIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHLORTHALIDONE, CHLORTHALIDONE

CIMETIDINE, CIMETIDINE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 137

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

CLOZAPINE, CLOZAPINE

COLCHICINE, COLCHICINE

CYCLOSPORINE, CYCLOSPORINE

CYSTAGON, CYSTEAMINE BITARTRATE

DAPSONE, DAPSONE

DENAVIR, PENCICLOVIR

DIAZEPAM, DIAZEPAM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ERMEZA, LEVOTHYROXINE SODIUM

ERYGEL, ERYTHROMYCIN

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

ESTRADIOL, ESTRADIOL

ETOPOSIDE, ETOPOSIDE

EVEROLIMUS, EVEROLIMUS

EXTINA, KETOCONAZOLE

FENOFIBRATE, FENOFIBRATE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FOSAMPRENAVIR CALCIUM, FOSAMPRENAVIR CALCIUM

FUROSEMIDE, FUROSEMIDE

GLATIRAMER ACETATE, GLATIRAMER ACETATE

HALCINONIDE, HALCINONIDE

HALOPERIDOL, HALOPERIDOL

IMATINIB MESYLATE, IMATINIB MESYLATE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LANSOPRAZOLE, LANSOPRAZOLE

LENALIDOMIDE, LENALIDOMIDE

LEVETIRACETAM, LEVETIRACETAM

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM

MERCAPTOPURINE, MERCAPTOPURINE

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIRTAZAPINE, MIRTAZAPINE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NEVIRAPINE, NEVIRAPINE

NISOLDIPINE, NISOLDIPINE

OLANZAPINE, OLANZAPINE

ONDANSETRON, ONDANSETRON

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

PHENYTEK, PHENYTOIN SODIUM

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRASUGREL, PRASUGREL HYDROCHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISONE, PREDNISONE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 138

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN PHARMACEUTICALS INC

REGADENOSON, REGADENOSON

ROFLUMILAST, ROFLUMILAST

RUFINAMIDE, RUFINAMIDE

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SORAFENIB TOSYLATE, SORAFENIB TOSYLATE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SUCRALFATE, SUCRALFATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SUNITINIB MALATE, SUNITINIB MALATE

SYMFI LO, EFAVIRENZ

TACROLIMUS, TACROLIMUS

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE

TELMISARTAN, TELMISARTAN

TERIFLUNOMIDE, TERIFLUNOMIDE

TETRABENAZINE, TETRABENAZINE

THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE

TIMOLOL MALEATE, TIMOLOL MALEATE

TRAVOPROST, TRAVOPROST

TRETINOIN, TRETINOIN

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

VALSARTAN, VALSARTAN

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VUSION, MICONAZOLE NITRATE

WIXELA INHUB, FLUTICASONE PROPIONATE

ZONALON, DOXEPIN HYDROCHLORIDE

* MYLAN PHARMACEUTICALS INC A VIATRIS CO

DAPTOMYCIN, DAPTOMYCIN

MYLAN ASI

* MYLAN ASI LLC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ADENOSINE, ADENOSINE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

MYLAN INSTITUTIONAL

* MYLAN INSTITUTIONAL INC

BUSULFAN, BUSULFAN

* MYLAN INSTITUTIONAL LLC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ARGATROBAN, ARGATROBAN

BIVALIRUDIN, BIVALIRUDIN

CIDOFOVIR, CIDOFOVIR

COSYNTROPIN, COSYNTROPIN

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DURACLON, CLONIDINE HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

FOMEPIZOLE, FOMEPIZOLE

IBUTILIDE FUMARATE, IBUTILIDE FUMARATE

ISOSULFAN BLUE, ISOSULFAN BLUE

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

RIMSO-50, DIMETHYL SULFOXIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SOTRADECOL, SODIUM TETRADECYL SULFATE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

TRANEXAMIC ACID, TRANEXAMIC ACID
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 139

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN INSTITUTIONAL LLC

ULTIVA, REMIFENTANIL HYDROCHLORIDE

MYLAN IRELAND LTD

* MYLAN IRELAND LTD

ARIXTRA, FONDAPARINUX SODIUM

MIACALCIN, CALCITONIN SALMON

PRETOMANID, PRETOMANID

YUPELRI, REVEFENACIN

MYLAN LABS LTD

* MYLAN LABORATORIES LTD

ABACAVIR SULFATE AND LAMIVUDINE, ABACAVIR SULFATE

ADENOSINE, ADENOSINE

BACLOFEN, BACLOFEN

CIMDUO, LAMIVUDINE

CLOFARABINE, CLOFARABINE

CYANOCOBALAMIN, CYANOCOBALAMIN

DAPTOMYCIN, DAPTOMYCIN

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

EPTIFIBATIDE, EPTIFIBATIDE

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ETOMIDATE, ETOMIDATE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM, HEPARIN SODIUM

IBANDRONATE SODIUM, IBANDRONATE SODIUM

LAMIVUDINE, LAMIVUDINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

LINEZOLID, LINEZOLID

MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE

MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

OXALIPLATIN, OXALIPLATIN

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

POSACONAZOLE, POSACONAZOLE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

RIFAMPIN, RIFAMPIN

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SYMFI, EFAVIRENZ
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 140

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN LABORATORIES LTD

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

MYLAN PHARMS INC

* MYLAN PHARMACEUTICALS INC

ABACAVIR SULFATE, ABACAVIR SULFATE

ACYCLOVIR, ACYCLOVIR

AMNESTEEM, ISOTRETINOIN

ARMODAFINIL, ARMODAFINIL

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AVITA, TRETINOIN

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

ESZOPICLONE, ESZOPICLONE

FENOFIBRATE, FENOFIBRATE

LANSOPRAZOLE, LANSOPRAZOLE

LITHIUM CARBONATE, LITHIUM CARBONATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

NEVIRAPINE, NEVIRAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RILUZOLE, RILUZOLE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VORICONAZOLE, VORICONAZOLE

ZIDOVUDINE, ZIDOVUDINE

* MYLAN PHARMACEUTICALS INC.

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

MYLAN SPCLT VIATRIS

* MYLAN SPECIALTY LP A VIATRIS CO

DIPENTUM, OLSALAZINE SODIUM

MYLAN SPECIALITY LP

* MYLAN SPECIALTY LP

COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350

CORTIFOAM, HYDROCORTISONE ACETATE

DEPEN, PENICILLAMINE

DYMISTA, AZELASTINE HYDROCHLORIDE

EDLUAR, ZOLPIDEM TARTRATE

ELESTRIN, ESTRADIOL

EPIFOAM, HYDROCORTISONE ACETATE

EPIPEN JR., EPINEPHRINE

EPIPEN, EPINEPHRINE

FELBATOL, FELBAMATE

GASTROCROM, CROMOLYN SODIUM

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

MUSE, ALPROSTADIL

PROCTOFOAM HC, HYDROCORTISONE ACETATE

ROWASA, MESALAMINE

SFROWASA, MESALAMINE

SOMA, CARISOPRODOL

TOBI PODHALER, TOBRAMYCIN

TOBI, TOBRAMYCIN

MYLAN SPECLT

* MYLAN SPECIALTY LP

PERFOROMIST, FORMOTEROL FUMARATE

MYLAN TECH VIATRIS

* MYLAN TECHNOLOGIES INC A VIATRIS CO
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 141

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** M **

* MYLAN TECHNOLOGIES INC A VIATRIS CO

METHYLPHENIDATE, METHYLPHENIDATE

MYLAN TECHNOLOGIES

* MYLAN TECHNOLOGIES INC

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CLONIDINE, CLONIDINE

ESTRADIOL, ESTRADIOL

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

FENTANYL-87, FENTANYL

LIDOCAINE, LIDOCAINE

NITROGLYCERIN, NITROGLYCERIN

RIVASTIGMINE, RIVASTIGMINE

SCOPOLAMINE, SCOPOLAMINE

XULANE, ETHINYL ESTRADIOL

MYOVANT SCIENCES

* MYOVANT SCIENCES GMBH

MYFEMBREE, ESTRADIOL

** N **

NAARI PTE LTD

* NAARI PTE LTD

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NORETHINDRONE, NORETHINDRONE

NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

NABRIVA

* NABRIVA THERAPEUTICS IRELAND DAC

XENLETA, LEFAMULIN ACETATE

NAL PHARM

* NAL PHARMACEUTICAL GROUP LTD

LIDOCAINE, LIDOCAINE

NALPROPION

* NALPROPION PHARMACEUTICALS LLC

CONTRAVE, BUPROPION HYDROCHLORIDE

NANG KUANG PHARM CO

* NANG KUANG PHARMACEUTICAL CO LTD

ICATIBANT ACETATE, ICATIBANT ACETATE

LINEZOLID, LINEZOLID

PEMETREXED DISODIUM, PEMETREXED DISODIUM

NANJING

* NANJING SIMCERE DONGYUAN PHARMACEUTICAL CO LTD

CELECOXIB, CELECOXIB

NANJING KING-FRIEND

* NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

NANOCOPOEIA

* NANOCOPOEIA LLC

PHYRAGO, DASATINIB

NAPO PHARMS INC

* NAPO PHARMACEUTICALS INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 142

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NAPO PHARMACEUTICALS INC

MYTESI, CROFELEMER

NATCO

* NATCO PHARMA LTD

ALPRAZOLAM, ALPRAZOLAM

CARISOPRODOL, CARISOPRODOL

GEFITINIB, GEFITINIB

GLYCOPYRROLATE, GLYCOPYRROLATE

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

NITROGLYCERIN, NITROGLYCERIN

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

TERIFLUNOMIDE, TERIFLUNOMIDE

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE, TIPIRACIL HYDROCHLORIDE

NATCO PHARMA

* NATCO PHARMA LTD

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

SUNITINIB MALATE, SUNITINIB MALATE

NATCO PHARMA LTD

* NATCO PHARMA LIMITED

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

* NATCO PHARMA LTD

ANASTROZOLE, ANASTROZOLE

ARMODAFINIL, ARMODAFINIL

AZACITIDINE, AZACITIDINE

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

LANSOPRAZOLE, LANSOPRAZOLE

LANTHANUM CARBONATE, LANTHANUM CARBONATE

LAPATINIB DITOSYLATE, LAPATINIB DITOSYLATE

LETROZOLE, LETROZOLE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

NAVINTA LLC

* NAVINTA LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

CARGLUMIC ACID, CARGLUMIC ACID

CARMUSTINE, CARMUSTINE

FAMOTIDINE, FAMOTIDINE

FOMEPIZOLE, FOMEPIZOLE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

METHOCARBAMOL, METHOCARBAMOL

PENICILLAMINE, PENICILLAMINE

RIBAVIRIN, RIBAVIRIN

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM PHENYLACETATE AND SODIUM BENZOATE, SODIUM BENZOATE

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

NCM USA BRONX LLC

* NCM USA BRONX LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

NE RX PHARMA

* NE RX PHARMA LLC

ACETAZOLAMIDE, ACETAZOLAMIDE

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

METOLAZONE, METOLAZONE

NEOS THERAPS

* NEOS THERAPEUTICS

ADZENYS XR-ODT, AMPHETAMINE

NEOS THERAPS INC

* NEOS THERAPEUTICS INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 143

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NEOS THERAPEUTICS INC

COTEMPLA XR-ODT, METHYLPHENIDATE

NEPHRON

* NEPHRON CORP

ALBUTEROL SULFATE, ALBUTEROL SULFATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

* NEPHRON PHARMACEUTICALS CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BUDESONIDE, BUDESONIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

NEURELIS INC

* NEURELIS INC

VALTOCO, DIAZEPAM

NEUROCRINE

* NEUROCRINE BIOSCIENCES INC

INGREZZA, VALBENAZINE TOSYLATE

ONGENTYS, OPICAPONE

NEXTWAVE

* NEXTWAVE PHARMACEUTICALS INC A SUB OF TRIS PHARMA INC

QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE

NEXTWAVE PHARMS

* NEXTWAVE PHARMACEUTICALS INC

QUILLICHEW ER, METHYLPHENIDATE HYDROCHLORIDE

NEXUS

* NEXUS PHARMACEUTICALS LLC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

BUSULFAN, BUSULFAN

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

EMERPHED, EPHEDRINE SULFATE

ERYTHROMYCIN LACTOBIONATE, ERYTHROMYCIN LACTOBIONATE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM

NELARABINE, NELARABINE

POTASSIUM CHLORIDE 10MEQ, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 20MEQ, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE 40MEQ, POTASSIUM CHLORIDE

PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

STERILE WATER FOR INJECTION, STERILE WATER FOR INJECTION

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

TIROFIBAN HYDROCHLORIDE, TIROFIBAN HYDROCHLORIDE

NEXUS PHARMS

* NEXUS PHARMACEUTICALS INC

FLUORESCEIN SODIUM, FLUORESCEIN SODIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

NIAGARA PHARMS

* NIAGARA PHARMACEUTICALS INC

PUR-WASH, PURIFIED WATER (OTC)

NIPPON SHINYAKU

* NIPPON SHINYAKU CO LTD

VILTEPSO, VILTOLARSEN

NIVAGEN PHARMS INC

* NIVAGEN PHARMACEUTICALS INC

CALCIUM GLUCONATE, CALCIUM GLUCONATE

DECITABINE, DECITABINE

EFINACONAZOLE, EFINACONAZOLE

TEMOZOLOMIDE, TEMOZOLOMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 144

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

NOBELPHARMA

* NOBELPHARMA CO LTD

HYFTOR, SIROLIMUS

NODEN PHARMA

* NODEN PHARMA DAC

TEKTURNA, ALISKIREN HEMIFUMARATE

NORTEC DEV ASSOC

* NORTEC DEVELOPMENT ASSOC INC

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

NORTHLAND

* NORTHLAND NUCLEAR MEDICINE LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

NORTHSTAR HLTHCARE

* NORTHSTAR HEALTHCARE HOLDINGS LTD

ALLOPURINOL, ALLOPURINOL

BACLOFEN, BACLOFEN

GEMFIBROZIL, GEMFIBROZIL

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

NORTON WATERFORD

* NORTON WATERFORD LTD

QVAR REDIHALER, BECLOMETHASONE DIPROPIONATE

NORWICH

* NORWICH PHARMACEUTICALS INC

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

NOSTRUM LABS INC

* NOSTRUM LABORATORIES INC

ACETAZOLAMIDE, ACETAZOLAMIDE

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, BISMUTH

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CALCIUM ACETATE, CALCIUM ACETATE

CARBAMAZEPINE, CARBAMAZEPINE

CARISOPRODOL, CARISOPRODOL

CLARITHROMYCIN, CLARITHROMYCIN

DAPSONE, DAPSONE

ELIXOPHYLLIN, THEOPHYLLINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE

HYDROCODONE, HYDROCODONE BITARTRATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NITROFURANTOIN, NITROFURANTOIN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

PINDOLOL, PINDOLOL

PIROXICAM, PIROXICAM

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SUCRALFATE, SUCRALFATE

THEOPHYLLINE, THEOPHYLLINE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

NOSTRUM PHARMS LLC

* NOSTRUM PHARMACEUTICALS LLC

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

THEOCHRON, THEOPHYLLINE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

NOVA LABS LTD

* NOVA LABORATORIES LTD

PURIXAN, MERCAPTOPURINE

NOVADAQ TECH

* NOVADAQ TECHNOLOGIES ULC

SPY AGENT GREEN KIT, INDOCYANINE GREEN

NOVARTIS

* NOVARTIS PHARMACEUTICALS CORP

AFINITOR, EVEROLIMUS
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 145

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVARTIS PHARMACEUTICALS CORP

ALOMIDE, LODOXAMIDE TROMETHAMINE

BETOPTIC S, BETAXOLOL HYDROCHLORIDE

COARTEM, ARTEMETHER

DESFERAL, DEFEROXAMINE MESYLATE

DIOVAN HCT, HYDROCHLOROTHIAZIDE

DIOVAN, VALSARTAN

EGATEN, TRICLABENDAZOLE

EXFORGE HCT, AMLODIPINE BESYLATE

EXFORGE, AMLODIPINE BESYLATE

EXJADE, DEFERASIROX

FABHALTA, IPTACOPAN HYDROCHLORIDE

GILENYA, FINGOLIMOD HYDROCHLORIDE

GLEEVEC, IMATINIB MESYLATE

JADENU SPRINKLE, DEFERASIROX

KISQALI FEMARA CO-PACK (COPACKAGED), LETROZOLE

KISQALI, RIBOCICLIB SUCCINATE

LEQVIO, INCLISIRAN SODIUM

LOCAMETZ, GALLIUM GA-68 GOZETOTIDE

MAYZENT, SIPONIMOD

MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE

MYFORTIC, MYCOPHENOLIC SODIUM

NEORAL, CYCLOSPORINE

PIQRAY, ALPELISIB

PLUVICTO, LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

PROMACTA KIT, ELTROMBOPAG OLAMINE

PROMACTA, ELTROMBOPAG OLAMINE

RYDAPT, MIDOSTAURIN

SANDIMMUNE, CYCLOSPORINE

SANDOSTATIN LAR, OCTREOTIDE ACETATE

SANDOSTATIN, OCTREOTIDE ACETATE

SCEMBLIX, ASCIMINIB HYDROCHLORIDE

TAFINLAR, DABRAFENIB MESYLATE

TASIGNA, NILOTINIB HYDROCHLORIDE

TEGRETOL, CARBAMAZEPINE

TEGRETOL-XR, CARBAMAZEPINE

TOBRADEX, DEXAMETHASONE

TOBREX, TOBRAMYCIN

TRILEPTAL, OXCARBAZEPINE

TYKERB, LAPATINIB DITOSYLATE

VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE

VIJOICE, ALPELISIB

VOTRIENT, PAZOPANIB HYDROCHLORIDE

XIIDRA, LIFITEGRAST

ZORTRESS, EVEROLIMUS

ZYKADIA, CERITINIB

NOVARTIS PHARM

* NOVARTIS PHARMACEUTICAL CORP

AFINITOR DISPERZ, EVEROLIMUS

TABRECTA, CAPMATINIB HYDROCHLORIDE

NOVARTIS PHARMS

* NOVARTIS PHARMACEUTICALS CORP

FEMARA, LETROZOLE

NOVARTIS PHARMS CORP

* NOVARTIS PHARMACEUTICALS CORP

ENTRESTO, SACUBITRIL

JADENU, DEFERASIROX

NOVAST LABS

* NOVAST LABORATORIES CHINA LTD

NORETHINDRONE, NORETHINDRONE

* NOVAST LABORATORIES INC

DOCETAXEL, DOCETAXEL

* NOVAST LABORATORIES LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 146

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVAST LABORATORIES LTD

CARBOPLATIN, CARBOPLATIN

CARISOPRODOL, CARISOPRODOL

CHABELINA FE, ETHINYL ESTRADIOL

CHLORTHALIDONE, CHLORTHALIDONE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DECITABINE, DECITABINE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOLISHALE, ETHINYL ESTRADIOL

ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

HER STYLE, LEVONORGESTREL (OTC)

INDOMETHACIN, INDOMETHACIN

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LARIN 1.5/30, ETHINYL ESTRADIOL

LARIN 1/20, ETHINYL ESTRADIOL

LARIN 24 FE, ETHINYL ESTRADIOL

LARIN FE 1.5/30, ETHINYL ESTRADIOL

LARIN FE 1/20, ETHINYL ESTRADIOL

LERIBANE, ETHINYL ESTRADIOL

LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM

LO-MALMOREDE, ETHINYL ESTRADIOL

MALMOREDE, ETHINYL ESTRADIOL

MELAMISA, DROSPIRENONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHENAMINE HIPPURATE, METHENAMINE HIPPURATE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

NIFEDIPINE, NIFEDIPINE

NORETHINDRONE ACETATE, NORETHINDRONE ACETATE

NORETHINDRONE, NORETHINDRONE

OXALIPLATIN, OXALIPLATIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PIMTREA, DESOGESTREL

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE

PROBENECID AND COLCHICINE, COLCHICINE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RANOLAZINE, RANOLAZINE

SETLAKIN, ETHINYL ESTRADIOL

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOLCAPONE, TOLCAPONE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

TRI-LO-LINYAH, ETHINYL ESTRADIOL

TRIAZOLAM, TRIAZOLAM

YAELA, DROSPIRENONE

NOVAST LABS LTD

* NOVAST LABORATORIES LTD

DASETTA 1/35, ETHINYL ESTRADIOL

DASETTA 7/7/7, ETHINYL ESTRADIOL

ELINEST, ETHINYL ESTRADIOL

FALMINA, ETHINYL ESTRADIOL

LEVONEST, ETHINYL ESTRADIOL

MONO-LINYAH, ETHINYL ESTRADIOL

PHILITH, ETHINYL ESTRADIOL

TRI-LINYAH, ETHINYL ESTRADIOL

WERA, ETHINYL ESTRADIOL

NOVATECH SA

* NOVATECH SA
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 147

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVATECH SA

STERITALC, TALC

NOVEL LABS INC

* NOVEL LABORATORIES INC

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

CARBIDOPA, CARBIDOPA

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

DESOXIMETASONE, DESOXIMETASONE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FAMOTIDINE, FAMOTIDINE

FLUCYTOSINE, FLUCYTOSINE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

LEVONORGESTREL, LEVONORGESTREL (OTC)

LINEZOLID, LINEZOLID

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, SODIUM PHOSPHATE, DIBASIC,

MORPHINE SULFATE, MORPHINE SULFATE

NITROFURANTOIN, NITROFURANTOIN

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND

PHENELZINE SULFATE, PHENELZINE SULFATE

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, MAGNESIUM SULFATE

TEMAZEPAM, TEMAZEPAM

TRIMETHOPRIM, TRIMETHOPRIM

VORICONAZOLE, VORICONAZOLE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

NOVELGENIX THERAPS

* NOVELGENIX THERAPEUTICS PVT LTD

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NOVEN

* NOVEN PHARMACEUTICALS INC

MINIVELLE, ESTRADIOL

NOVEN PHARMS INC

* NOVEN PHARMACEUTICALS INC

COMBIPATCH, ESTRADIOL

DAYTRANA, METHYLPHENIDATE

XELSTRYM, DEXTROAMPHETAMINE

NOVITIUM PHARMA

* NOVITIUM PHARMA LLC

ACETAZOLAMIDE, ACETAZOLAMIDE

ACYCLOVIR, ACYCLOVIR

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALPRAZOLAM, ALPRAZOLAM

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

BETAINE, BETAINE

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

CARBAMAZEPINE, CARBAMAZEPINE

CARGLUMIC ACID, CARGLUMIC ACID

CHLORZOXAZONE, CHLORZOXAZONE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 148

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVITIUM PHARMA LLC

CLOTRIMAZOLE, CLOTRIMAZOLE

DAPSONE, DAPSONE

DEXAMETHASONE, DEXAMETHASONE

DIAZOXIDE, DIAZOXIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIGOXIN, DIGOXIN

ESTAZOLAM, ESTAZOLAM

ESTRADIOL, ESTRADIOL

FAMOTIDINE, FAMOTIDINE

FELBAMATE, FELBAMATE

FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

LACOSAMIDE, LACOSAMIDE

LEVOCARNITINE SF, LEVOCARNITINE

LEVOCARNITINE, LEVOCARNITINE

LEVOFLOXACIN, LEVOFLOXACIN

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MELOXICAM, MELOXICAM

METHSUXIMIDE, METHSUXIMIDE

METHYLTESTOSTERONE, METHYLTESTOSTERONE

NAPROXEN, NAPROXEN

NITISINONE, NITISINONE

NITROFURANTOIN, NITROFURANTOIN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREDNISONE, PREDNISONE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PYRAZINAMIDE, PYRAZINAMIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RIFABUTIN, RIFABUTIN

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SIROLIMUS, SIROLIMUS

SOVUNA, HYDROXYCHLOROQUINE SULFATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

TADALAFIL, TADALAFIL

THIOTHIXENE, THIOTHIXENE

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

VALSARTAN, VALSARTAN

NOVO

* NOVO NORDISK INC

OZEMPIC, SEMAGLUTIDE

RIVFLOZA, NEDOSIRAN SODIUM

RYBELSUS, SEMAGLUTIDE

SAXENDA, LIRAGLUTIDE RECOMBINANT

WEGOVY, SEMAGLUTIDE

NOVO NORDISK

* NOVO NORDISK PHARMACEUTICALS INC

GLUCAGEN, GLUCAGON HYDROCHLORIDE

NOVO NORDISK INC

* NOVO NORDISK INC

VAGIFEM, ESTRADIOL

VICTOZA, LIRAGLUTIDE RECOMBINANT

NOVUGEN

* NOVUGEN ONCOLOGY SDN BHD

ABIRATERONE ACETATE, ABIRATERONE ACETATE

SUNITINIB MALATE, SUNITINIB MALATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 149

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** N **

* NOVUGEN PHARMA MALAYSIA SDN BHD

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

NUKEMED

* NUKEMED INC DBA SPECTRONRX

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

NUVO PHARM

* NUVO PHARMACEUTICAL INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

NUVO PHARMS INC

* NUVO PHAMACEUTICALS INC

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

NAPROXEN, NAPROXEN

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

SULFASALAZINE, SULFASALAZINE

NXDC

* NX DEVELOPMENT CORP

GLEOLAN, AMINOLEVULINIC ACID HYDROCHLORIDE

** O **

OCULAR THERAPEUTIX

* OCULAR THERAPEUTIX INC

DEXTENZA, DEXAMETHASONE

OCUPHIRE

* OCUPHIRE PHARMA INC

RYZUMVI, PHENTOLAMINE MESYLATE

OHM LABS

* OHM LABORATORIES INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

OHM LABS INC

* OHM LABORATORIES INC

EZETIMIBE, EZETIMIBE

GUAIFENESIN, GUAIFENESIN (OTC)

VALSARTAN, VALSARTAN

OMNIVIUM PHARMS

* OMNIVIUM PHARMACEUTICALS LLC

ISONIAZID, ISONIAZID

NUMBRINO, COCAINE HYDROCHLORIDE

SODIUM BICARBONATE, SODIUM BICARBONATE

OMSAV PHARMA

* OMSAV PHARMA RESEARCH PRIVATE LTD

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

ON TARGET LABS

* ON TARGET LABORATORIES INC

CYTALUX, PAFOLACIANINE SODIUM

ONYX PHARMS AMGEN

* ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC

KYPROLIS, CARFILZOMIB

OPERAND PHARMS

* OPERAND PHARMACEUTICALS III LTD

EPHEDRINE SULFATE, EPHEDRINE SULFATE

OPTIMUS

* OPTIMUS PHARMA PRIVATE LTD
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 150

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* OPTIMUS PHARMA PRIVATE LTD

AMINOCAPROIC ACID, AMINOCAPROIC ACID

BREXPIPRAZOLE, BREXPIPRAZOLE

OPTINOSE US INC

* OPTINOSE US INC

XHANCE, FLUTICASONE PROPIONATE

ORAPHARMA

* ORAPHARMA INC

ARESTIN, MINOCYCLINE HYDROCHLORIDE

ORASIS PHARMS

* ORASIS PHARMACEUTICALS LTD

QLOSI, PILOCARPINE HYDROCHLORIDE

ORBICULAR

* ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LTD

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ORBION PHARMS

* ORBION PHARMACEUTICALS PRIVATE LTD

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ARIPIPRAZOLE, ARIPIPRAZOLE

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

DESLORATADINE, DESLORATADINE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

ESZOPICLONE, ESZOPICLONE

FELODIPINE, FELODIPINE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

LEVETIRACETAM, LEVETIRACETAM

LEVOFLOXACIN, LEVOFLOXACIN

MODAFINIL, MODAFINIL

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

OLANZAPINE, OLANZAPINE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

RASAGILINE MESYLATE, RASAGILINE MESYLATE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZALEPLON, ZALEPLON

ZOLMITRIPTAN, ZOLMITRIPTAN

OREXO US INC

* OREXO US INC

ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE

ORGANON

* ORGANON LLC A SUB OF ORGANON AND CO

CELESTONE SOLUSPAN, BETAMETHASONE ACETATE

CLARINEX, DESLORATADINE

COZAAR, LOSARTAN POTASSIUM

DIPROLENE, BETAMETHASONE DIPROPIONATE

FOSAMAX, ALENDRONATE SODIUM

HYZAAR, HYDROCHLOROTHIAZIDE

MAXALT-MLT, RIZATRIPTAN BENZOATE

PROPECIA, FINASTERIDE

PROSCAR, FINASTERIDE

SINEMET, CARBIDOPA

SINGULAIR, MONTELUKAST SODIUM

VYTORIN, EZETIMIBE

ZETIA, EZETIMIBE

ZOCOR, SIMVASTATIN

* ORGANON USA LLC

NEXPLANON, ETONOGESTREL

REMERON, MIRTAZAPINE

ORGANON LLC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 151

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* ORGANON LLC

ASMANEX HFA, MOMETASONE FUROATE

ASMANEX TWISTHALER, MOMETASONE FUROATE

CLARINEX-D 12 HOUR, DESLORATADINE

DULERA, FORMOTEROL FUMARATE

FOSAMAX PLUS D, ALENDRONATE SODIUM

MAXALT, RIZATRIPTAN BENZOATE

ORGANON USA ORGANON

* ORGANON USA LLC A SUB OF ORGANON AND CO

GANIRELIX ACETATE, GANIRELIX ACETATE

NUVARING, ETHINYL ESTRADIOL

REMERON SOLTAB, MIRTAZAPINE

ORIENT PHARMA

* ORIENT PHARMA CO LTD

EZETIMIBE, EZETIMIBE

ORIENT PHARMA CO LTD

* ORIENT PHARMA CO LTD

CARISOPRODOL, CARISOPRODOL

GLYBURIDE, GLYBURIDE

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ORION PHARMA

* ORION PHARMA

COMTAN, ENTACAPONE

STALEVO 100, CARBIDOPA

STALEVO 125, CARBIDOPA

STALEVO 150, CARBIDOPA

STALEVO 200, CARBIDOPA

STALEVO 50, CARBIDOPA

STALEVO 75, CARBIDOPA

ORPHALAN

* ORPHALAN SA

CUVRIOR, TRIENTINE TETRAHYDROCHLORIDE

OSMOTICA PHARM US

* OSMOTICA PHARMACEUTICAL US LLC

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NIFEDIPINE, NIFEDIPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

RELEXXII, METHYLPHENIDATE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

OTSUKA

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY ASIMTUFII, ARIPIPRAZOLE

ABILIFY MYCITE KIT, ARIPIPRAZOLE

ABILIFY, ARIPIPRAZOLE

INQOVI, CEDAZURIDINE

JYNARQUE, TOLVAPTAN

REXULTI, BREXPIPRAZOLE

SAMSCA, TOLVAPTAN

OTSUKA PHARM

* OTSUKA PHARMACEUTICAL CO LTD

BUSULFEX, BUSULFAN

OTSUKA PHARM CO LTD

* OTSUKA PHARMACEUTICAL CO LTD

ABILIFY MAINTENA KIT, ARIPIPRAZOLE

OTTER PHARMS

* OTTER PHARMACEUTICALS LLC

OTREXUP, METHOTREXATE

SYMPAZAN, CLOBAZAM

OVERSEAS

* OVERSEAS PHARMACEUTICALS LTD

LEVETIRACETAM, LEVETIRACETAM

OXFORD PHARMS
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 152

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** O **

* OXFORD PHARMACEUTICALS LLC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

BACLOFEN, BACLOFEN

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARISOPRODOL, CARISOPRODOL

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIPYRIDAMOLE, DIPYRIDAMOLE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

LORAZEPAM, LORAZEPAM

METHOCARBAMOL, METHOCARBAMOL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PRIMIDONE, PRIMIDONE

RIMACTANE, RIFAMPIN

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SIMVASTATIN, SIMVASTATIN

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SPIRONOLACTONE, SPIRONOLACTONE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

OYSTER POINT PHARMA

* OYSTER POINT PHARMA INC

TYRVAYA, VARENICLINE TARTRATE

** P **

P AND L

* P AND L DEVELOPMENT LLC

ADAPALENE, ADAPALENE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

DOCOSANOL, DOCOSANOL (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)

MICONAZOLE 7, MICONAZOLE NITRATE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

P AND L DEV LLC

* P AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLC

IBUPROFEN, IBUPROFEN (OTC)

PACIFIC PHARMA

* PACIFIC PHARMA

TIMOLOL MALEATE, TIMOLOL MALEATE

* PACIFIC PHARMA INC

TIMOLOL MALEATE, TIMOLOL MALEATE

PACIRA PHARMS INC

* PACIRA PHARMACEUTICALS INC

EXPAREL, BUPIVACAINE

ZILRETTA, TRIAMCINOLONE ACETONIDE

PADAGIS ISRAEL

* PADAGIS ISRAEL PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

AMMONIUM LACTATE, AMMONIUM LACTATE

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE, AZELASTINE HYDROCHLORIDE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 153

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PADAGIS ISRAEL PHARMACEUTICALS LTD

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BUDESONIDE, BUDESONIDE

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CALCIPOTRIENE AND BETHAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CYANOCOBALAMIN, CYANOCOBALAMIN

DAPSONE, DAPSONE

DESOXIMETASONE, DESOXIMETASONE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ESTRADIOL, ESTRADIOL

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

FLURANDRENOLIDE, FLURANDRENOLIDE

FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE

GYNAZOLE-1, BUTOCONAZOLE NITRATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

IMIQUIMOD, IMIQUIMOD

IVERMECTIN, IVERMECTIN

KETOCONAZOLE, KETOCONAZOLE

MESALAMINE, MESALAMINE

METRONIDAZOLE, METRONIDAZOLE

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (OTC)

NITROGLYCERIN, NITROGLYCERIN

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

PERMETHRIN, PERMETHRIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SUMATRIPTAN, SUMATRIPTAN

TAZAROTENE, TAZAROTENE

TERCONAZOLE, TERCONAZOLE

TESTOSTERONE, TESTOSTERONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

PADAGIS US

* PADAGIS US LLC

BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC

BACITRACIN, BACITRACIN

BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN ZINC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BRINZOLAMIDE, BRINZOLAMIDE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CALCIUM ACETATE, CALCIUM ACETATE

CENTANY, MUPIROCIN

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CICLOPIROX, CICLOPIROX

CLINDA-DERM, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLINDESSE, CLINDAMYCIN PHOSPHATE

CLINDETS, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

COMPRO, PROCHLORPERAZINE

CYCLOSPORINE, CYCLOSPORINE

DESONIDE, DESONIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 154

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PADAGIS US LLC

DESOXIMETASONE, DESOXIMETASONE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

ENTOCORT EC, BUDESONIDE

ERYTHROMYCIN, ERYTHROMYCIN

EVAMIST, ESTRADIOL

FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

HYDROCORTISONE, HYDROCORTISONE

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LIDOCAINE AND PRILOCAINE, LIDOCAINE

MIDAMOR, AMILORIDE HYDROCHLORIDE

MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MOMETASONE FUROATE, MOMETASONE FUROATE

MORPHINE SULFATE, MORPHINE SULFATE

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE

NYSTATIN, NYSTATIN

NYSTOP, NYSTATIN

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

PODOFILOX, PODOFILOX

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

REPAGLINIDE, REPAGLINIDE

SCOPOLAMINE, SCOPOLAMINE

SELENIUM SULFIDE, SELENIUM SULFIDE

STIE-CORT, HYDROCORTISONE

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TAVABOROLE, TAVABOROLE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE

TRETINOIN, TRETINOIN

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TROSPIUM CHLORIDE, TROSPIUM CHLORIDE

PAI HOLDINGS PHARM

* PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

LACTULOSE, LACTULOSE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LITHIUM CITRATE, LITHIUM CITRATE

PHENYTOIN, PHENYTOIN

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

PALATIN TECHNOLOGIES

* PALATIN TECHNOLOGIES INC

VYLEESI (AUTOINJECTOR), BREMELANOTIDE ACETATE

PANACEA

* PANACEA BIOTEC PHARMA LTD

PRASUGREL, PRASUGREL HYDROCHLORIDE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

TACROLIMUS, TACROLIMUS

PAR FORM

* PAR FORMULATIONS PRIVATE LTD

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

PAR PHARM

* PAR PHARMACEUTICAL

EVEROLIMUS, EVEROLIMUS
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 155

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PAR PHARMACEUTICAL INC

ALPRAZOLAM, ALPRAZOLAM

ALVIMOPAN, ALVIMOPAN

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, BISMUTH

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CLONAZEPAM, CLONAZEPAM

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROXYUREA, HYDROXYUREA

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LAMOTRIGINE, LAMOTRIGINE

MINOXIDIL, MINOXIDIL

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

PIMOZIDE, PIMOZIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TOPIRAMATE, TOPIRAMATE

URSODIOL, URSODIOL

PAR PHARM INC

* PAR PHARMACEUTICAL INC

AMBRISENTAN, AMBRISENTAN

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

CHLORZOXAZONE, CHLORZOXAZONE

COLCHICINE, COLCHICINE

DEXLANSOPRAZOLE, DEXLANSOPRAZOLE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE

ETHACRYNIC ACID, ETHACRYNIC ACID

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

PENICILLAMINE, PENICILLAMINE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PRAZIQUANTEL, PRAZIQUANTEL

SAPROPTERIN DIHYDROCHLORIDE, SAPROPTERIN DIHYDROCHLORIDE

TIOPRONIN, TIOPRONIN

TOLCAPONE, TOLCAPONE

TOLVAPTAN, TOLVAPTAN

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

VARENICLINE TARTRATE, VARENICLINE TARTRATE

VIGABATRIN, VIGABATRIN

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

PAR STERILE PRODUCTS

* PAR STERILE PRODUCTS LLC

ADRENALIN, EPINEPHRINE

ARGATROBAN, ARGATROBAN

BREVITAL SODIUM, METHOHEXITAL SODIUM

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

CALCITONIN-SALMON, CALCITONIN SALMON

COLY-MYCIN M, COLISTIMETHATE SODIUM

CORPHEDRA, EPHEDRINE SULFATE

DANTRIUM, DANTROLENE SODIUM

DELESTROGEN, ESTRADIOL VALERATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 156

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PAR STERILE PRODUCTS LLC

KETALAR, KETAMINE HYDROCHLORIDE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

MICAFUNGIN, MICAFUNGIN SODIUM

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PITOCIN, OXYTOCIN

POSACONAZOLE, POSACONAZOLE

TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE

TREPROSTINIL, TREPROSTINIL

VASOSTRICT, VASOPRESSIN

PARAGON BIOTECK

* PARAGON BIOTECK INC

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PARAPRO LLC

* PARAPRO LLC

NATROBA, SPINOSAD

PARATEK PHARMS INC

* PARATEK PHARMACEUTICALS INC

NUZYRA, OMADACYCLINE TOSYLATE

PARKE DAVIS

* PARKE DAVIS DIV WARNER LAMBERT CO

CELONTIN, METHSUXIMIDE

CEREBYX, FOSPHENYTOIN SODIUM

NARDIL, PHENELZINE SULFATE

ZARONTIN, ETHOSUXIMIDE

PARKE-DAVIS

* PARKE-DAVIS DIVISION OF PFIZER INC

ZARONTIN, ETHOSUXIMIDE

PATHEON SOFTGELS

* PATHEON SOFTGELS BV

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

PATRIN

* PATRIN PHARMA INC

CALCITRIOL, CALCITRIOL

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

FLAC, FLUOCINOLONE ACETONIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

PREGABALIN, PREGABALIN

PENN LIFE

* PENN LIFE SCIENCES LLC

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

CARMUSTINE, CARMUSTINE

ISOPROTERENOL HYDROCHLORIDE, ISOPROTERENOL HYDROCHLORIDE

THIOTEPA, THIOTEPA

PERRIGO NEW YORK

* PERRIGO NEW YORK INC

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

PERMETHRIN, PERMETHRIN (OTC)

PERRIGO PHARMA INTL

* PERRIGO PHARMA INTERNATIONAL DAC

DICLOFENAC SODIUM, DICLOFENAC SODIUM (OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

MINOXIDIL, MINOXIDIL (OTC)

NASONEX 24HR ALLERGY, MOMETASONE FUROATE (OTC)

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE (OTC)

* PERRIGO PHARMA INTERNATIONAL DESIGNATED ACTIVITY CO

LORATADINE, LORATADINE (OTC)

PREVACID 24 HR, LANSOPRAZOLE (OTC)

PERRIGO R AND D

* PERRIGO R AND D CO

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 157

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PERRIGO R AND D CO

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)

FAMOTIDINE, FAMOTIDINE (OTC)

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUAIFENESIN, GUAIFENESIN (OTC)

IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)

IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LANSOPRAZOLE, LANSOPRAZOLE (OTC)

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE (OTC)

LEVONORGESTREL, LEVONORGESTREL (OTC)

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

PETNET

* PETNET SOLUTIONS INC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

PF PRISM CV

* PF PRISM CV

BOSULIF, BOSUTINIB MONOHYDRATE

INLYTA, AXITINIB

PRISTIQ, DESVENLAFAXINE SUCCINATE

RAPAMUNE, SIROLIMUS

TORISEL, TEMSIROLIMUS

TYGACIL, TIGECYCLINE

VFEND, VORICONAZOLE

XALKORI, CRIZOTINIB

XELJANZ, TOFACITINIB CITRATE

PFIZER

* PFIZER CENTRAL RESEARCH

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER CHEMICALS DIV PFIZER INC

DIFLUCAN, FLUCONAZOLE

ZITHROMAX, AZITHROMYCIN

* PFIZER INC

ALDACTAZIDE, HYDROCHLOROTHIAZIDE

ALDACTONE, SPIRONOLACTONE

AROMASIN, EXEMESTANE

ARTHROTEC, DICLOFENAC SODIUM

AZULFIDINE EN-TABS, SULFASALAZINE

AZULFIDINE, SULFASALAZINE

CAVERJECT IMPULSE, ALPROSTADIL

CAVERJECT, ALPROSTADIL

CIBINQO, ABROCITINIB

CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLEOCIN T, CLINDAMYCIN PHOSPHATE

CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE

CLEOCIN, CLINDAMYCIN PHOSPHATE

COLESTID, COLESTIPOL HYDROCHLORIDE

CORVERT, IBUTILIDE FUMARATE

CYKLOKAPRON, TRANEXAMIC ACID

CYTOTEC, MISOPROSTOL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 158

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PFIZER INC

DAURISMO, GLASDEGIB MALEATE

DAYPRO, OXAPROZIN

DEPO-ESTRADIOL, ESTRADIOL CYPIONATE

DEPO-MEDROL, METHYLPREDNISOLONE ACETATE

DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE

DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE

DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

ESTRING, ESTRADIOL

FLAGYL, METRONIDAZOLE

FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE

FRAGMIN, DALTEPARIN SODIUM

GLUCOTROL XL, GLIPIZIDE

GLYNASE, GLYBURIDE

GLYSET, MIGLITOL

HALCION, TRIAZOLAM

HEMABATE, CARBOPROST TROMETHAMINE

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

IBRANCE, PALBOCICLIB

IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE

LINCOCIN, LINCOMYCIN HYDROCHLORIDE

LITFULO, RITLECITINIB TOSYLATE

LOMOTIL, ATROPINE SULFATE

LORBRENA, LORLATINIB

MEDROL, METHYLPREDNISOLONE

MERREM, MEROPENEM

MYCOBUTIN, RIFABUTIN

NICOTROL, NICOTINE

NORPACE CR, DISOPYRAMIDE PHOSPHATE

NORPACE, DISOPYRAMIDE PHOSPHATE

NURTEC ODT, RIMEGEPANT SULFATE

OGEN 5, ESTROPIPATE

PAXLOVID (COPACKAGED), NIRMATRELVIR

PREPIDIL, DINOPROSTONE

PROCARDIA, NIFEDIPINE

PROSTIN VR PEDIATRIC, ALPROSTADIL

PROVERA, MEDROXYPROGESTERONE ACETATE

SONATA, ZALEPLON

SYNAREL, NAFARELIN ACETATE

TALZENNA, TALAZOPARIB TOSYLATE

TESSALON, BENZONATATE

TOVIAZ, FESOTERODINE FUMARATE

UNASYN, AMPICILLIN SODIUM

VELSIPITY, ETRASIMOD ARGININE

VIZIMPRO, DACOMITINIB

XELJANZ XR, TOFACITINIB CITRATE

XELJANZ, TOFACITINIB CITRATE

ZAVZPRET, ZAVEGEPANT HYDROCHLORIDE

ZITHROMAX, AZITHROMYCIN

ZYVOX, LINEZOLID

* PFIZER LABORATORIES DIV PFIZER INC

FELDENE, PIROXICAM

MINIPRESS, PRAZOSIN HYDROCHLORIDE

PFIZERPEN, PENICILLIN G POTASSIUM

PROCARDIA XL, NIFEDIPINE

VIBRAMYCIN, DOXYCYCLINE

VIBRAMYCIN, DOXYCYCLINE CALCIUM

VIBRAMYCIN, DOXYCYCLINE HYCLATE

VISTARIL, HYDROXYZINE PAMOATE

* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD

TIKOSYN, DOFETILIDE

PFIZER INC

* PFIZER INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 159

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PFIZER INC

CAMPTOSAR, IRINOTECAN HYDROCHLORIDE

ELLENCE, EPIRUBICIN HYDROCHLORIDE

NICOTROL, NICOTINE

PFIZER PHARMS

* PFIZER PHARMACEUTICALS LTD

LOPID, GEMFIBROZIL

PHARM ASSOC

* PHARMACEUTICAL ASSOC INC

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LORAZEPAM, LORAZEPAM

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

* PHARMACEUTICAL ASSOCIATES INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ETHOSUXIMIDE, ETHOSUXIMIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL LACTATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LACTULOSE, LACTULOSE

LEVETIRACETAM, LEVETIRACETAM

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE

PREDNISOLONE, PREDNISOLONE

PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE

PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE

THEOPHYLLINE, THEOPHYLLINE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

PHARM SOURCING

* PHARMACEUTICAL SOURCING PARTNERS INC

MESALAMINE, MESALAMINE

PHARMA RES SOFTWARE

* PHARMA RESEARCH SOFTWARE SOLUTION LLC

POKONZA, POTASSIUM CHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PHARMACHEMIE BV

* PHARMACHEMIE BV

CARBOPLATIN, CARBOPLATIN

CISPLATIN, CISPLATIN

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

PHARMACIA

* PHARMACIA AND UPJOHN CO LLC

CADUET, AMLODIPINE BESYLATE

DILANTIN, PHENYTOIN

PHARMACIA AND UPJOHN

* PHARMACIA AND UPJOHN CO
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 160

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PHARMACIA AND UPJOHN CO

CORTEF, HYDROCORTISONE

EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM

R-GENE 10, ARGININE HYDROCHLORIDE

SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE

SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE

PHARMACOSMOS AS

* PHARMACOSMOS AS

MONOFERRIC, FERRIC DERISOMALTOSE

PHARMACYCLICS LLC

* PHARMACYCLICS LLC

IMBRUVICA, IBRUTINIB

PHARMADAX INC

* PHARMADAX INC

LEVETIRACETAM, LEVETIRACETAM

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

PHARMALOGIC

* PHARMALOGIC SOUTH CAROLINA LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

PHARMALOGIC HLDGS

* PHARMALOGIC HOLDINGS CORP

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

PHARMASCIENCE INC

* PHARMASCIENCE INC

BORTEZOMIB, BORTEZOMIB

BUSULFAN, BUSULFAN

DECITABINE, DECITABINE

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

PHARMING

* PHARMING TECHNOLOGIES BV

JOENJA, LENIOLISIB PHOSPHATE

PHATHOM

* PHATHOM PHARMACEUTICALS INC

VOQUEZNA DUAL PAK, AMOXICILLIN

VOQUEZNA TRIPLE PAK, AMOXICILLIN

VOQUEZNA, VONOPRAZAN FUMARATE

PHOTOCURE ASA

* PHOTOCURE ASA

CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE

PIERRE FABRE DERMA

* PIERRE FABRE DERMATOLOGIE

HEMANGEOL, PROPRANOLOL HYDROCHLORIDE

PIERREL

* PIERREL S.P.A.

ORABLOC, ARTICAINE HYDROCHLORIDE

PINNACLE BIOLGS

* PINNACLE BIOLOGICS INC

PHOTOFRIN, PORFIMER SODIUM

PIRAMAL CRITICAL

* PIRAMAL CRITICAL CARE INC

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

GABLOFEN, BACLOFEN

GLYCOPYRROLATE, GLYCOPYRROLATE

ISOFLURANE, ISOFLURANE

MITIGO, MORPHINE SULFATE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SOJOURN, SEVOFLURANE

* PIRAMAL CRITICAL CARE LTD

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

PIRAMAL HLTHCARE UK

* PIRAMAL HEALTHCARE UK LTD

CLOBAZAM, CLOBAZAM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 161

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PIRAMAL HEALTHCARE UK LTD

DEFERASIROX, DEFERASIROX

EPLERENONE, EPLERENONE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

RANOLAZINE, RANOLAZINE

TETRABENAZINE, TETRABENAZINE

PIRAMAL PHARMA

* PIRAMAL PHARMA LTD

ISOFLURANE, ISOFLURANE

PLD ACQUISITIONS

* PLD ACQUISITIONS LLC DBA AVEMA PHARMA SOLUTIONS

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)

PLD ACQUISITIONS LLC

* PLD ACQUISITIONS LLC

LORATADINE, LORATADINE (OTC)

ZOLMITRIPTAN, ZOLMITRIPTAN

PLIVA

* PLIVA INC

AZITHROMYCIN, AZITHROMYCIN

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

PLIVA PHARM IND

* PLIVA PHARMACEUTICAL INDUSTRY INC

TORSEMIDE, TORSEMIDE

PLX PHARMA

* PLX PHARMA INC

VAZALORE, ASPIRIN (OTC)

POHL BOSKAMP

* POHL BOSKAMP

NITROLINGUAL PUMPSPRAY, NITROGLYCERIN

POLAREAN

* POLAREAN INC

XENOVIEW, XENON XE-129 HYPERPOLARIZED

POLYGEN PHARMS

* POLYGEN PHARMACEUTICALS INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

POWDER PHARMS

* POWDER PHARMACEUTICALS INC

ZINGO, LIDOCAINE HYDROCHLORIDE

PRASCO

* PRASCO LLC DBA PRASCO LABORATORIES

DEXAMETHASONE, DEXAMETHASONE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

EPLERENONE, EPLERENONE

ESTRADIOL, ESTRADIOL

MIRTAZAPINE, MIRTAZAPINE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

PRAXGEN

* PRAXGEN PHARMACEUTICALS LLC

METHYLPREDNISOLONE, METHYLPREDNISOLONE

RANOLAZINE, RANOLAZINE

PRECISION DERMAT

* PRECISION DERMATOLOGY INC

LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE

LOCOID, HYDROCORTISONE BUTYRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 162

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

PRECISION DOSE INC

* PRECISION DOSE INC

PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE

PRECISION NUCLEAR

* PRECISION NUCLEAR LLC

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

PRIMUS PHARMS

* PRIMUS PHARMACEUTICALS INC

IMPOYZ, CLOBETASOL PROPIONATE

SERNIVO, BETAMETHASONE DIPROPIONATE

PRINSTON INC

* PRINSTON PHARMACEUTICAL INC

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

ARIPIPRAZOLE, ARIPIPRAZOLE

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CAPTOPRIL, CAPTOPRIL

CLONAZEPAM, CLONAZEPAM

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENTECAVIR, ENTECAVIR

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

FEBUXOSTAT, FEBUXOSTAT

FENOFIBRATE, FENOFIBRATE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

FUROSEMIDE, FUROSEMIDE

GLIMEPIRIDE, GLIMEPIRIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LEVETIRACETAM, LEVETIRACETAM

LEVOMILNACIPRAN HYDROCHLORIDE, LEVOMILNACIPRAN HYDROCHLORIDE

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOCARBAMOL, METHOCARBAMOL

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PAROXETINE MESYLATE, PAROXETINE MESYLATE

PAROXETINE, PAROXETINE HYDROCHLORIDE

PEMETREXED DISODIUM, PEMETREXED DISODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 163

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PRINSTON PHARMACEUTICAL INC

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

PREGABALIN, PREGABALIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROFLUMILAST, ROFLUMILAST

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

SILODOSIN, SILODOSIN

TADALAFIL, TADALAFIL

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

VALSARTAN, VALSARTAN

VORICONAZOLE, VORICONAZOLE

VYDUO, NEBIVOLOL HYDROCHLORIDE

PROF DSPLS

* PROFESSIONAL DISPOSABLES INC

PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE (OTC)

PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)

PROGENICS PHARMS INC

* PROGENICS PHARMACEUTICALS INC

AZEDRA, IOBENGUANE I-131

PYLARIFY, PIFLUFOLASTAT F-18

PROPEL PHARMA

* PROPEL PHARMA CORP

VIGABATRIN, VIGABATRIN

PROTEGA PHARMS

* PROTEGA PHARMACEUTICALS INC

ROXYBOND, OXYCODONE HYDROCHLORIDE

PROVELL

* PROVELL PHARMACEUTICALS LLC

EUTHYROX, LEVOTHYROXINE SODIUM **

PROVENSIS

* PROVENSIS LTD

VARITHENA, POLIDOCANOL

PROVEPHARM SAS

* PROVEPHARM SAS

BAL, DIMERCAPROL

BLUDIGO, INDIGOTINDISULFONATE SODIUM

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PROVAYBLUE, METHYLENE BLUE

TRANEXAMIC ACID, TRANEXAMIC ACID

PTC THERAP

* PTC THERAPEUTICS INC

EMFLAZA, DEFLAZACORT

PULMOFLOW INC

* PULMOFLOW INC

KITABIS PAK, TOBRAMYCIN

PUMA BIOTECH

* PUMA BIOTECHNOLOGY INC

NERLYNX, NERATINIB MALEATE

PURACAP PHARM

* PURACAP PHARMACEUTICAL LLC

MELOXICAM, MELOXICAM

PURACAP PHARM LLC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 164

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** P **

* PURACAP PHARMACEUTICAL LLC

BENZONATATE, BENZONATATE

ERGOCALCIFEROL, ERGOCALCIFEROL

ETHOSUXIMIDE, ETHOSUXIMIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PURDUE PHARMA LP

* PURDUE PHARMA LP

BUTRANS, BUPRENORPHINE

HYSINGLA ER, HYDROCODONE BITARTRATE

MS CONTIN, MORPHINE SULFATE

NALMEFENE HYDROCHLORIDE, NALMEFENE HYDROCHLORIDE

OXYCONTIN, OXYCODONE HYDROCHLORIDE

PURE SOURCE

* PURE SOURCE LLC

THEROXIDIL, MINOXIDIL (OTC)

PYROS PHARMS

* PYROS PHARMACEUTICALS INC

VIGPODER, VIGABATRIN

** Q **

Q BIOMED

* Q BIOMED INC

METASTRON, STRONTIUM CHLORIDE SR-89

STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89

QILU

* QILU PHARMACEUTICAL CO LTD

ABIRATERONE ACETATE, ABIRATERONE ACETATE

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CEFTRIAXONE, CEFTRIAXONE SODIUM

EXEMESTANE, EXEMESTANE

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

QILU PHARM HAINAN

* QILU PHARMACEUTICAL HAINAN CO LTD

BORTEZOMIB, BORTEZOMIB

DAPTOMYCIN, DAPTOMYCIN

DECITABINE, DECITABINE

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

GEFITINIB, GEFITINIB

IMATINIB MESYLATE, IMATINIB MESYLATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PEMETREXED DISODIUM, PEMETREXED DISODIUM

TADALAFIL, TADALAFIL

QINGDAO BAHEAL PHARM

* QINGDAO BAHEAL PHARMACEUTICAL CO LTD

CELECOXIB, CELECOXIB

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FOLIC ACID, FOLIC ACID

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHIMAZOLE, METHIMAZOLE

QOL MEDCL

* QOL MEDICAL LLC

ETHAMOLIN, ETHANOLAMINE OLEATE

QUAGEN

* QUAGEN PHARMACEUTICALS LLC

ALBUTEROL SULFATE, ALBUTEROL SULFATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 165

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Q **

* QUAGEN PHARMACEUTICALS LLC

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE, LIDOCAINE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPYLTHIOURACIL, PROPYLTHIOURACIL

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

QUEEN HAMAMATSU PET

* QUEEN HAMAMATSU PET IMAGING CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

** R **

R-PHARM US LLC

* R-PHARM US LLC

IXEMPRA KIT, IXABEPILONE

RADIOMEDIX

* RADIOMEDIX INC

DETECTNET, COPPER CU-64 DOTATATE

RADIUS

* RADIUS HEALTH INC

BINOSTO, ALENDRONATE SODIUM

TYMLOS, ABALOPARATIDE

RAYNER SURGICAL

* RAYNER SURGICAL INC

OMIDRIA, KETOROLAC TROMETHAMINE

RB HLTH

* RB HEALTH US LLC

DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)

MUCINEX D, GUAIFENESIN (OTC)

MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

MUCINEX, GUAIFENESIN (OTC)

REATA PHARMS

* REATA PHARMACEUTICALS INC

SKYCLARYS, OMAVELOXOLONE

RECORDATI RARE

* RECORDATI RARE DISEASES INC

CARBAGLU, CARGLUMIC ACID

CHEMET, SUCCIMER

COSMEGEN, DACTINOMYCIN

CYSTADANE, BETAINE

CYSTADROPS, CYSTEAMINE HYDROCHLORIDE

ISTURISA, OSILODROSTAT PHOSPHATE

NEOPROFEN, IBUPROFEN LYSINE

SIGNIFOR LAR KIT, PASIREOTIDE PAMOATE

SIGNIFOR, PASIREOTIDE DIASPARTATE

REDHILL

* REDHILL BIOPHARMA INC

AEMCOLO, RIFAMYCIN SODIUM

* REDHILL BIOPHARMA LTD

TALICIA, AMOXICILLIN

RELIANCE LIFE

* RELIANCE LIFE SCIENCES PVT LTD

CAPECITABINE, CAPECITABINE

REMPEX

* REMPEX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF MELINTA THERAPEUTICS LLC

MINOCIN, MINOCYCLINE HYDROCHLORIDE

VABOMERE, MEROPENEM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 166

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

RENATA

* RENATA LTD

FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

PREGABALIN, PREGABALIN

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

RENEW PHARMS

* RENEW PHARMACEUTICALS LTD

INDOCYANINE GREEN, INDOCYANINE GREEN

RESILIA PHARMS

* RESILIA PHARMACEUTICALS INC

ECOZA, ECONAZOLE NITRATE

REYOUNG

* REYOUNG CORPORATION

FENOFIBRATE (MICRONIZED), FENOFIBRATE

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

RHODES PHARMS

* RHODES PHARMACEUTICALS LP

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

APTENSIO XR, METHYLPHENIDATE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DILAUDID, HYDROMORPHONE HYDROCHLORIDE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FENOFIBRATE, FENOFIBRATE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

MORPHINE SULFATE, MORPHINE SULFATE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

RHYTHM

* RHYTHM PHARMACEUTICALS INC

IMCIVREE, SETMELANOTIDE ACETATE

RICONPHARMA LLC

* RICONPHARMA LLC

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE, BISMUTH

CARBAMAZEPINE, CARBAMAZEPINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FLUNISOLIDE, FLUNISOLIDE

ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

SCOPOLAMINE, SCOPOLAMINE

RIGEL PHARMS INC

* RIGEL PHARMACEUTICALS INC

REZLIDHIA, OLUTASIDENIB

TAVALISSE, FOSTAMATINIB DISODIUM

RILEY CONSUMER

* RILEY CONSUMER CARE LLC DBA CARLIN CONSUMER HEALTH

ZEGERID OTC, OMEPRAZOLE (OTC)

RISE PHARMA

* RISE PHARMA LLC

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CHLORZOXAZONE, CHLORZOXAZONE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

KETOCONAZOLE, KETOCONAZOLE

RISING
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 167

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* RISING PHARMA HOLDING INC

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE

BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE

CAPECITABINE, CAPECITABINE

CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CYTARABINE, CYTARABINE

DIGOXIN, DIGOXIN

DIPYRIDAMOLE, DIPYRIDAMOLE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

FLUMAZENIL, FLUMAZENIL

FLUNISOLIDE, FLUNISOLIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

* RISING PHARMA HOLDINGS INC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACETIC ACID, ACETIC ACID, GLACIAL

ACETYLCYSTEINE, ACETYLCYSTEINE

ADENOSINE, ADENOSINE

AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALFENTA, ALFENTANIL HYDROCHLORIDE

ALOSETRON HYDROCHLORIDE, ALOSETRON HYDROCHLORIDE

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE

ATROPINE SULFATE, ATROPINE SULFATE

AZATHIOPRINE, AZATHIOPRINE

BACLOFEN, BACLOFEN

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BUDESONIDE, BUDESONIDE

BUMETANIDE, BUMETANIDE

CALCITRIOL, CALCITRIOL

CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

CICLOPIROX, CICLOPIROX

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CROMOLYN SODIUM, CROMOLYN SODIUM

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DAPSONE, DAPSONE

DESOXIMETASONE, DESOXIMETASONE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXERCALCIFEROL, DOXERCALCIFEROL

EPLERENONE, EPLERENONE

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

EXEMESTANE, EXEMESTANE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCORTISONE, HYDROCORTISONE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 168

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* RISING PHARMA HOLDINGS INC

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

INDAPAMIDE, INDAPAMIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED), AMOXICILLIN

LEVETIRACETAM, LEVETIRACETAM

LEVOCARNITINE, LEVOCARNITINE

LEVOFLOXACIN, LEVOFLOXACIN

LINEZOLID, LINEZOLID

LORAZEPAM, LORAZEPAM

METHIMAZOLE, METHIMAZOLE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NADOLOL, NADOLOL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)

NATEGLINIDE, NATEGLINIDE

NEMBUTAL SODIUM, PENTOBARBITAL SODIUM

NITAZOXANIDE, NITAZOXANIDE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PARICALCITOL, PARICALCITOL

PERPHENAZINE, PERPHENAZINE

PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE

PHENYTOIN, PHENYTOIN

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

PREGABALIN, PREGABALIN

PROBENECID AND COLCHICINE, COLCHICINE

PROBENECID, PROBENECID

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RANOLAZINE, RANOLAZINE

RISPERIDONE, RISPERIDONE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE

SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE

SULFAMYLON, MAFENIDE ACETATE

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

TEMOZOLOMIDE, TEMOZOLOMIDE

THIOTHIXENE, THIOTHIXENE

TIMOLOL MALEATE, TIMOLOL MALEATE

TOLMETIN SODIUM, TOLMETIN SODIUM

TOREMIFENE CITRATE, TOREMIFENE CITRATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

TROPICACYL, TROPICAMIDE

VORICONAZOLE, VORICONAZOLE

ZILEUTON, ZILEUTON

* RISING PHARMACEUTICALS

URSODIOL, URSODIOL

RISING PHARMS

* RISING PHARMACEUTICALS INC

ZAFIRLUKAST, ZAFIRLUKAST

RK PHARMA

* RK PHARMA INC

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 169

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* RK PHARMA INC

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MITOMYCIN, MITOMYCIN

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

NADOLOL, NADOLOL

PALIPERIDONE, PALIPERIDONE

URSODIOL, URSODIOL

ROCHE PALO

* ROCHE PALO ALTO LLC

CELLCEPT, MYCOPHENOLATE MOFETIL

CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

ROMARK

* ROMARK LABORATORIES

ALINIA, NITAZOXANIDE

ROXANE

* ROXANE LABORATORIES INC

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

RUBICON

* RUBICON RESEARCH PRIVATE LTD

ACETAZOLAMIDE, ACETAZOLAMIDE

ACYCLOVIR, ACYCLOVIR

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

ARIPIPRAZOLE, ARIPIPRAZOLE

BACLOFEN, BACLOFEN

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARVEDILOL, CARVEDILOL

CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GLIPIZIDE, GLIPIZIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LITHIUM CITRATE, LITHIUM CITRATE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

NITROGLYCERIN, NITROGLYCERIN

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 170

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** R **

* RUBICON RESEARCH PRIVATE LTD

PREGABALIN, PREGABALIN

PRIMIDONE, PRIMIDONE

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

RVL PHARMS

* RVL PHARMACEUTICALS INC

UPNEEQ, OXYMETAZOLINE HYDROCHLORIDE

** S **

SAGE CHEMS

* SAGE CHEMICALS INC

APOMORPHINE HYDROCHLORIDE, APOMORPHINE HYDROCHLORIDE

SAGE PRODS

* SAGE PRODUCTS INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)

SAGE THERAP

* SAGE THERAPEUTICS INC

ZULRESSO, BREXANOLONE

SAGENT

* SAGENT PHARMACEUTICALS

BUMETANIDE, BUMETANIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE

FAMOTIDINE, FAMOTIDINE

FUROSEMIDE, FUROSEMIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

VALPROATE SODIUM, VALPROATE SODIUM

SAGENT PHARMS

* SAGENT PHARMACEUTICALS INC

CAFFEINE CITRATE, CAFFEINE CITRATE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

FLUMAZENIL, FLUMAZENIL

HALOPERIDOL, HALOPERIDOL LACTATE

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LEVETIRACETAM, LEVETIRACETAM

NAFCILLIN SODIUM, NAFCILLIN SODIUM

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXACILLIN SODIUM, OXACILLIN SODIUM

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

SAGENT PHARMS INC

* SAGENT PHARMACEUTICALS INC

ACETYLCYSTEINE, ACETYLCYSTEINE

AMIKACIN SULFATE, AMIKACIN SULFATE

AMPICILLIN SODIUM, AMPICILLIN SODIUM

CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

CYANOCOBALAMIN, CYANOCOBALAMIN

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DAPTOMYCIN, DAPTOMYCIN

DECITABINE, DECITABINE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EPTIFIBATIDE, EPTIFIBATIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 171

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SAGENT PHARMACEUTICALS INC

ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE

FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE

FLUOROURACIL, FLUOROURACIL

FULVESTRANT, FULVESTRANT

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GLYDO, LIDOCAINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM

LINEZOLID, LINEZOLID

MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE

MESNA, MESNA

METHOCARBAMOL, METHOCARBAMOL

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

OXYTOCIN, OXYTOCIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM

PENTOBARBITAL SODIUM, PENTOBARBITAL SODIUM

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PROPOFOL, PROPOFOL

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

ZOLEDRONIC ACID, ZOLEDRONIC ACID

SALIX

* SALIX PHARMACEUTICALS INC

APRISO, MESALAMINE

FENOGLIDE, FENOFIBRATE

PLENVU, ASCORBIC ACID

RELISTOR, METHYLNALTREXONE BROMIDE

TRULANCE, PLECANATIDE

UCERIS, BUDESONIDE

ZEGERID, OMEPRAZOLE

SALIX PHARMS

* SALIX PHARMACEUTICALS INC

ANUSOL HC, HYDROCORTISONE

DIURIL, CHLOROTHIAZIDE

MOVIPREP, ASCORBIC ACID

RELISTOR, METHYLNALTREXONE BROMIDE

XIFAXAN, RIFAXIMIN

SAMSON MEDCL

* SAMSON MEDICAL TECHNOLOGIES LLC

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFEPIME HYDROCHLORIDE IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE

CEFOXITIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE

SANDOZ

* SANDOZ

DOCETAXEL, DOCETAXEL

* SANDOZ INC

ACETAMINOPHEN, ACETAMINOPHEN

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALPRAZOLAM, ALPRAZOLAM

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 172

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE

ANECTINE, SUCCINYLCHOLINE CHLORIDE

ANGIOMAX, BIVALIRUDIN

APREPITANT, APREPITANT

ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN

ARRANON, NELARABINE

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

AZITHROMYCIN, AZITHROMYCIN

AZOPT, BRINZOLAMIDE

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE

BETOPTIC, BETAXOLOL HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BIMATOPROST, BIMATOPROST

BORTEZOMIB, BORTEZOMIB

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BRIMONIDINE TARTRATE

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE

BUDESONIDE, BUDESONIDE

BUMETANIDE, BUMETANIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBOPLATIN, CARBOPLATIN

CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE

CARVEDILOL, CARVEDILOL

CEFAZOLIN SODIUM, CEFAZOLIN SODIUM

CEFDINIR, CEFDINIR

CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CILOXAN, CIPROFLOXACIN HYDROCHLORIDE

CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE

CIPRODEX, CIPROFLOXACIN

CLARITHROMYCIN, CLARITHROMYCIN

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONAZEPAM, CLONAZEPAM

COSYNTROPIN, COSYNTROPIN

CROMOLYN SODIUM, CROMOLYN SODIUM

CYANOCOBALAMIN, CYANOCOBALAMIN

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

CYCLOSPORINE, CYCLOSPORINE

DECITABINE, DECITABINE

DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIGOXIN, DIGOXIN

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE

DOXERCALCIFEROL, DOXERCALCIFEROL

DUREZOL, DIFLUPREDNATE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

EPHEDRINE SULFATE, EPHEDRINE SULFATE

EPLERENONE, EPLERENONE

ETODOLAC, ETODOLAC

EXELON, RIVASTIGMINE

EZETIMIBE, EZETIMIBE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 173

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE

FERUMOXYTOL, FERUMOXYTOL

FLUMAZENIL, FLUMAZENIL

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM

FULVESTRANT, FULVESTRANT

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GATIFLOXACIN, GATIFLOXACIN

GENTAMICIN SULFATE, GENTAMICIN SULFATE

GLATOPA, GLATIRAMER ACETATE

GLIPIZIDE, GLIPIZIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

HEPARIN SODIUM, HEPARIN SODIUM

HYCAMTIN, TOPOTECAN HYDROCHLORIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

INDOMETHACIN, INDOMETHACIN

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

ISONIAZID, ISONIAZID

ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

ITRACONAZOLE, ITRACONAZOLE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED), AMOXICILLIN

LANSOPRAZOLE, LANSOPRAZOLE

LATANOPROST, LATANOPROST

LESCOL XL, FLUVASTATIN SODIUM

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVOFLOXACIN, LEVOFLOXACIN

LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN CALCIUM

LINEZOLID, LINEZOLID

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOTREL, AMLODIPINE BESYLATE

MAXITROL, DEXAMETHASONE

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOLAZONE, METOLAZONE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

MYDRIACYL, TROPICAMIDE

NADOLOL, NADOLOL

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE

NEVIRAPINE, NEVIRAPINE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 174

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SANDOZ INC

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

OMEPRAZOLE, OMEPRAZOLE

OMNIPRED, PREDNISOLONE ACETATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

OXALIPLATIN, OXALIPLATIN

OXAPROZIN, OXAPROZIN

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PARICALCITOL, PARICALCITOL

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM

PENICILLIN G SODIUM, PENICILLIN G SODIUM

PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM

PERPHENAZINE, PERPHENAZINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PIRFENIDONE, PIRFENIDONE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

QOLIANA, BRIMONIDINE TARTRATE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RECLAST, ZOLEDRONIC ACID

REGONOL, PYRIDOSTIGMINE BROMIDE

RIBAVIRIN, RIBAVIRIN

RISPERIDONE, RISPERIDONE

RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE

RITALIN, METHYLPHENIDATE HYDROCHLORIDE

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILODOSIN, SILODOSIN

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TACROLIMUS, TACROLIMUS

TAFLUPROST, TAFLUPROST

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TELMISARTAN, TELMISARTAN

TEMAZEPAM, TEMAZEPAM

TERIFLUNOMIDE, TERIFLUNOMIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TIGECYCLINE, TIGECYCLINE

TIMOLOL MALEATE, TIMOLOL MALEATE

TOBRADEX, DEXAMETHASONE

TOBREX, TOBRAMYCIN

TRAVATAN Z, TRAVOPROST

TREPROSTINIL, TREPROSTINIL

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIAZOLAM, TRIAZOLAM

TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE

TRIFLURIDINE, TRIFLURIDINE

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VIVELLE-DOT, ESTRADIOL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SANDOZ CANADA INC

* SANDOZ CANADA INC

INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE

INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID

INFUVITE PEDIATRIC, ASCORBIC ACID
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 175

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

SANDOZ INC

* SANDOZ INC

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

CEFTRIAXONE, CEFTRIAXONE SODIUM

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ENOXAPARIN SODIUM, ENOXAPARIN SODIUM

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

OLANZAPINE, OLANZAPINE

ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE

SANOFI

* SANOFI AVENTIS US LLC

FEXINIDAZOLE, FEXINIDAZOLE

FLOMAX, TAMSULOSIN HYDROCHLORIDE

* SANOFI GENZYME

HECTOROL, DOXERCALCIFEROL

RENVELA, SEVELAMER CARBONATE

SANOFI AVENTIS US

* SANOFI AVENTIS US INC

JEVTANA KIT, CABAZITAXEL

* SANOFI AVENTIS US LLC

AMARYL, GLIMEPIRIDE

AMBIEN CR, ZOLPIDEM TARTRATE

AMBIEN, ZOLPIDEM TARTRATE

ARAVA, LEFLUNOMIDE

AUBAGIO, TERIFLUNOMIDE

AVALIDE, HYDROCHLOROTHIAZIDE

AVAPRO, IRBESARTAN

DIABETA, GLYBURIDE

ELOXATIN, OXALIPLATIN

FERRLECIT, FERRIC OXYHYDROXIDE

LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM

LOVENOX, ENOXAPARIN SODIUM

MULTAQ, DRONEDARONE HYDROCHLORIDE

PLAVIX, CLOPIDOGREL BISULFATE

PRIFTIN, RIFAPENTINE

PRIMAQUINE, PRIMAQUINE PHOSPHATE

RIFADIN, RIFAMPIN

TAXOTERE, DOCETAXEL

SANTARUS INC

* SANTARUS INC

GLUMETZA, METFORMIN HYDROCHLORIDE

SAPTALIS PHARMS

* SAPTALIS PHARMACEUTICALS LLC

ACETIC ACID, ACETIC ACID, GLACIAL

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

LEVOCARNITINE, LEVOCARNITINE

LIKMEZ, METRONIDAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

VOSOL HC, ACETIC ACID, GLACIAL

SAREPTA THERAPS INC

* SAREPTA THERAPEUTICS INC

AMONDYS 45, CASIMERSEN

EXONDYS 51, ETEPLIRSEN

VYONDYS 53, GOLODIRSEN

SARFE PHARMS

* SARFEZ PHARMACEUTICALS INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 176

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SARFEZ PHARMACEUTICALS INC

SOAANZ, TORSEMIDE

SAVIOR LIFETEC CORP

* SAVIOR LIFETEC CORP

ERTAPENEM SODIUM, ERTAPENEM SODIUM

MEROPENEM, MEROPENEM

SAWAI USA

* SAWAI USA INC

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

SCHERING

* SCHERING CORP

NOXAFIL, POSACONAZOLE

SCIARRA LABS

* SCIARRA LABORATORIES INC

SCLEROSOL, TALC

TALC, TALC

SCIECURE PHARMA INC

* SCIECURE PHARMA INC

CARBAMAZEPINE, CARBAMAZEPINE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

SCIEGEN PHARMS INC

* SCIEGEN PHARMACEUTICALS INC

ARIPIPRAZOLE, ARIPIPRAZOLE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARISOPRODOL, CARISOPRODOL

CELECOXIB, CELECOXIB

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DROXIDOPA, DROXIDOPA

ETHACRYNIC ACID, ETHACRYNIC ACID

EZETIMIBE, EZETIMIBE

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

HALOPERIDOL, HALOPERIDOL

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LACOSAMIDE, LACOSAMIDE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LISINOPRIL, LISINOPRIL

METAXALONE, METAXALONE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NABUMETONE, NABUMETONE

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

NAPROXEN SODIUM, NAPROXEN SODIUM

NAPROXEN, NAPROXEN

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

PHYTONADIONE, PHYTONADIONE

PIRFENIDONE, PIRFENIDONE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PREGABALIN, PREGABALIN

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RANOLAZINE, RANOLAZINE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 177

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SCIEGEN PHARMACEUTICALS INC

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

VALPROIC ACID, VALPROIC ACID

VALSARTAN, VALSARTAN

SCILEX HLDG

* SCILEX HOLDING CO

ELYXYB, CELECOXIB

SCILEX PHARMS

* SCILEX PHARMACEUTICALS INC

GLOPERBA, COLCHICINE

ZTLIDO, LIDOCAINE

SCINOPHARM TAIWAN

* SCINOPHARM TAIWAN LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FONDAPARINUX SODIUM, FONDAPARINUX SODIUM

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

SCPHARMACEUTICALS

* SCPHARMACEUTICALS INC

FUROSCIX, FUROSEMIDE

SCYNEXIS

* SCYNEXIS INC

BREXAFEMME, IBREXAFUNGERP CITRATE

SEAGEN

* SEAGEN INC

TUKYSA, TUCATINIB

SEBELA IRELAND LTD

* SEBELA IRELAND LTD

BRISDELLE, PAROXETINE MESYLATE

IMURAN, AZATHIOPRINE

LOTRONEX, ALOSETRON HYDROCHLORIDE

MICORT-HC, HYDROCORTISONE ACETATE

MOTOFEN, ATROPINE SULFATE

NAFTIN, NAFTIFINE HYDROCHLORIDE

PRAMOSONE, HYDROCORTISONE ACETATE

RIDAURA, AURANOFIN

SECURA

* SECURA BIO INC

COPIKTRA, DUVELISIB

SENORES PHARMS

* SENORES PHARMACEUTICALS INC

BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE

SENTISS

* SENTISS AG

ALBUTEROL SULFATE, ALBUTEROL SULFATE

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BRIMONIDINE TARTRATE

BROMFENAC SODIUM, BROMFENAC SODIUM

CIPROFLOXACIN AND DEXAMETHASONE, CIPROFLOXACIN

ERYTHROMYCIN, ERYTHROMYCIN

KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LOTEPREDNOL ETABONATE, LOTEPREDNOL ETABONATE

OFLOXACIN, OFLOXACIN

SENTISS PHARMA

* SENTISS PHARMA PRIVATE LTD

TIMOLOL MALEATE, TIMOLOL MALEATE

SENTYNL THERAPS INC

* SENTYNL THERAPEUTICS INC

NULIBRY, FOSDENOPTERIN HYDROBROMIDE

SEPTODONT
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 178

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SEPTODONT INC

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE

DYCLOPRO, DYCLONINE HYDROCHLORIDE

SEPTODONT HOLDING

* SEPTODONT HOLDING SAS

ORAVERSE, PHENTOLAMINE MESYLATE

SEPTODONT INC

* SEPTODONT INC

LIDOCAINE, LIDOCAINE

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE

PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE

SERVIER

* SERVIER PHARMACEUTICALS LLC

TIBSOVO, IVOSIDENIB

SETON PHARM

* SETON PHARMACEUTICAL LLC

PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE

SETON PHARMS

* SETON PHARMACEUTICALS LLC

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

SHANDONG

* SHANDONG ANXIN PHARMACEUTICAL CO LTD

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

* SHANDONG NEW TIME PHARMACEUTICAL CO LTD

MILRINONE LACTATE, MILRINONE LACTATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SEVOFLURANE, SEVOFLURANE

SHANDONG LUYE

* SHANDONG LUYE PHARMACEUTICAL CO LTD

RYKINDO, RISPERIDONE

SHANDONG XINHUA

* SHANDONG XINHUA PHARMACEUTICAL CO LTD

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

SHANGHAI HENGRUI

* SHANGHAI HENGRUI PHARMACEUTICAL CO LTD

DESFLURANE, DESFLURANE

SEVOFLURANE, SEVOFLURANE

SHENZHEN TECHDOW

* SHENZHEN TECHDOW PHARMACEUTICAL CO LTD

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM

HEPARIN SODIUM, HEPARIN SODIUM

SHIELD TX

* SHIELD TX UK LTD

ACCRUFER, FERRIC MALTOL

SHILPA

* SHILPA MEDICARE LTD

APREMILAST, APREMILAST

BUSULFAN, BUSULFAN

CAPECITABINE, CAPECITABINE

DOCETAXEL, DOCETAXEL

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

IMATINIB MESYLATE, IMATINIB MESYLATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PEMETREXED, PEMETREXED DISODIUM

SHILPA MEDICARE

* SHILPA MEDICARE LTD

AZACITIDINE, AZACITIDINE

SHIONOGI INC

* SHIONOGI INC

FETROJA, CEFIDEROCOL SULFATE TOSYLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 179

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

SHORLA

* SHORLA PHARMA LTD

JYLAMVO, METHOTREXATE

NELARABINE, NELARABINE

SIDMAK LABS INDIA

* SIDMAK LABORATORIES INDIA PVT LTD

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

SIGA TECHNOLOGIES

* SIGA TECHNOLOGIES INC

TPOXX, TECOVIRIMAT

SIGMAPHARM LABS LLC

* SIGMAPHARM LABORATORIES LLC

ACITRETIN, ACITRETIN

ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL

AMBRISENTAN, AMBRISENTAN

AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE

ASENAPINE MALEATE, ASENAPINE MALEATE

DISULFIRAM, DISULFIRAM

DOFETILIDE, DOFETILIDE

FLUCYTOSINE, FLUCYTOSINE

GRISEOFULVIN, GRISEOFULVIN, MICROSIZE

GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE

SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE

SINOTHERAPEUTICS INC

* SINOTHERAPEUTICS INC

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

MESALAMINE, MESALAMINE

POSACONAZOLE, POSACONAZOLE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

SINTETICA US

* SINTETICA US LLC

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

SK LIFE

* SK LIFE SCIENCE INC

XCOPRI, CENOBAMATE

SKYEPHARMA AG

* SKYEPHARMA AG

TRIGLIDE, FENOFIBRATE

SLATE RUN PHARMA

* SLATE RUN PHARMACEUTICALS LLC

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

AZITHROMYCIN, AZITHROMYCIN

BIVALIRUDIN, BIVALIRUDIN

CILOSTAZOL, CILOSTAZOL

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DROXIDOPA, DROXIDOPA

EPTIFIBATIDE, EPTIFIBATIDE

GANCICLOVIR SODIUM, GANCICLOVIR SODIUM

METHOCARBAMOL, METHOCARBAMOL

PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE

VORICONAZOLE, VORICONAZOLE

SLAYBACK PHARMA LLC

* SLAYBACK PHARMA LLC

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

DEOXYCHOLIC ACID, DEOXYCHOLIC ACID

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

FORMOTEROL FUMARATE, FORMOTEROL FUMARATE

ICATIBANT ACETATE, ICATIBANT ACETATE

LOTEPREDNOL ETABONATE, LOTEPREDNOL ETABONATE

MERZEE, ETHINYL ESTRADIOL

METARAMINOL BITARTRATE, METARAMINOL BITARTRATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 180

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SLAYBACK PHARMA LLC

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

PREVDUO, GLYCOPYRROLATE

TOFACITINIB CITRATE, TOFACITINIB CITRATE

VIVIMUSTA, BENDAMUSTINE HYDROCHLORIDE

SOCIETAL CDMO

* SOCIETAL CDMO GAINESVILLE LLC

VERELAN PM, VERAPAMIL HYDROCHLORIDE

VERELAN, VERAPAMIL HYDROCHLORIDE

SOFGEN PHARMS

* SOFGEN PHARMACEUTICALS LLC

IBUPROFEN, IBUPROFEN (OTC)

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

PROGESTERONE, PROGESTERONE

SOFIE

* SOFIE CO DBA SOFIE

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

* SOFIE CO DBA SOFIE (FKA ZEVACOR PHARMA INC)

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

SOLA PHARMS

* SOLA PHARMACEUTICALS

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CYANOCOBALAMIN, CYANOCOBALAMIN

DIMETHYL FUMARATE, DIMETHYL FUMARATE

TERIFLUNOMIDE, TERIFLUNOMIDE

SOLARIS PHARMA CORP

* SOLARIS PHARMA CORP

CLINDAMYCIN PHOSPHATE AND TRETINOIN, CLINDAMYCIN PHOSPHATE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

METRONIDAZOLE, METRONIDAZOLE

TAZAROTENE, TAZAROTENE

SOLUBIOMIX

* SOLUBIOMIX LLC

COXANTO, OXAPROZIN

SOMERSET

* SOMERSET PHARMACEUTICALS INC

EMSAM, SELEGILINE

* SOMERSET THERAPEUTICS LLC

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

CALCIUM GLUCONATE, CALCIUM GLUCONATE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE

LATANOPROST, LATANOPROST

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

SOMERSET THERAPS LLC

* SOMERSET THERAPEUTICS LLC

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BIMATOPROST, BIMATOPROST

BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE

CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE

CYANOCOBALAMIN, CYANOCOBALAMIN

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE, DEXAMETHASONE SODIUM PHOSPHATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE

GLYCOPYRROLATE, GLYCOPYRROLATE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

METHOCARBAMOL, METHOCARBAMOL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 181

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SOMERSET THERAPEUTICS LLC

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE

PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE

ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TOBRAMYCIN, TOBRAMYCIN

TROPICAMIDE, TROPICAMIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

SPECGX LLC

* SPECGX LLC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE

ANEXSIA 5/325, ACETAMINOPHEN

ANEXSIA 7.5/325, ACETAMINOPHEN

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

FENTANYL-100, FENTANYL

FENTANYL-12, FENTANYL

FENTANYL-25, FENTANYL

FENTANYL-37, FENTANYL

FENTANYL-50, FENTANYL

FENTANYL-62, FENTANYL

FENTANYL-75, FENTANYL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

METHADOSE, METHADONE HYDROCHLORIDE

METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE

METHYLIN, METHYLPHENIDATE HYDROCHLORIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

OXYCET, ACETAMINOPHEN

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

PAMELOR, NORTRIPTYLINE HYDROCHLORIDE

POSACONAZOLE, POSACONAZOLE

RESTORIL, TEMAZEPAM

ROXICODONE, OXYCODONE HYDROCHLORIDE

TOFRANIL, IMIPRAMINE HYDROCHLORIDE

SPECTRA MDCL DEVICES

* SPECTRA MEDICAL DEVICES INC

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE

SPIL

* SUN PHARMA INDUSTRIES LTD

AMPHOTERICIN B, AMPHOTERICIN B

ASPRUZYO SPRINKLE, RANOLAZINE

KAPSPARGO SPRINKLE, METOPROLOL SUCCINATE

NIFEDIPINE, NIFEDIPINE

OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)

SPRINGWORKS

* SPRINGWORKS THERAPEUTICS INC

OGSIVEO, NIROGACESTAT HYDROBROMIDE

SPROUT PHARMS

* SPROUT PHARMACEUTICALS INC

ADDYI, FLIBANSERIN

SQUARE PHARMS
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 182

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SQUARE PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

ARIPIPRAZOLE, ARIPIPRAZOLE

CALCIUM ACETATE, CALCIUM ACETATE

MIRTAZAPINE, MIRTAZAPINE

VALSARTAN, VALSARTAN

SS PHARMA

* SS PHARMA LLC

DRISDOL, ERGOCALCIFEROL

HIPREX, METHENAMINE HIPPURATE

PARLODEL, BROMOCRIPTINE MESYLATE

ROCALTROL, CALCITRIOL

ST RENATUS

* ST RENATUS LLC

KOVANAZE, OXYMETAZOLINE HYDROCHLORIDE

STALLION LABS

* STALLION LABORATORIES PRIVATE LTD

LEVETIRACETAM, LEVETIRACETAM

STAND HOMEOPATH

* STANDARD HOMEOPATHIC CO

IVY BLOCK, BENTOQUATAM (OTC)

STASON PHARMS

* STASON PHARMACEUTICALS INC

PURINETHOL, MERCAPTOPURINE

STEMLINE THERAP

* STEMLINE THERAPEUTICS INC

ORSERDU, ELACESTRANT DIHYDROCHLORIDE

STERISCIENCE

* STERISCIENCE PTE LTD

ACETYLCYSTEINE, ACETYLCYSTEINE

AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM

AMPICILLIN SODIUM, AMPICILLIN SODIUM

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE

BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

FOCINVEZ, FOSAPREPITANT DIMEGLUMINE

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE

MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NAFCILLIN SODIUM, NAFCILLIN SODIUM

OXACILLIN SODIUM, OXACILLIN SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

SODIUM BICARBONATE, SODIUM BICARBONATE

STI PHARMA LLC

* STI PHARMA LLC

MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE

STIEFEL

* STIEFEL LABORATORIES INC

DUAC, BENZOYL PEROXIDE

STRIDES PHARMA

* STRIDES PHARMA GLOBAL PTE LTD

ABACAVIR SULFATE, ABACAVIR SULFATE

ACARBOSE, ACARBOSE

ACCOLATE, ZAFIRLUKAST

ACETAZOLAMIDE, ACETAZOLAMIDE

ACYCLOVIR, ACYCLOVIR

ALBENDAZOLE, ALBENDAZOLE

ALPRAZOLAM, ALPRAZOLAM

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

BENZONATATE, BENZONATATE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 183

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* STRIDES PHARMA GLOBAL PTE LTD

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN

BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN

CABERGOLINE, CABERGOLINE

CALCITRIOL, CALCITRIOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CLARITHROMYCIN, CLARITHROMYCIN

COLCHICINE, COLCHICINE

CYCLOSPORINE, CYCLOSPORINE

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIAZEPAM, DIAZEPAM

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DOFETILIDE, DOFETILIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

DOXYCYCLINE, DOXYCYCLINE

DUTASTERIDE, DUTASTERIDE

EFAVIRENZ, EFAVIRENZ

EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ERGOCALCIFEROL, ERGOCALCIFEROL

ETHOSUXIMIDE, ETHOSUXIMIDE

FLUCYTOSINE, FLUCYTOSINE

GABAPENTIN, GABAPENTIN

HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCORTISONE, HYDROCORTISONE

IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

ICOSAPENT ETHYL, ICOSAPENT ETHYL

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

KETOCONAZOLE, KETOCONAZOLE

LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE

LAMIVUDINE, LAMIVUDINE

LEVETIRACETAM, LEVETIRACETAM

LIDOCAINE, LIDOCAINE

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MEGESTROL ACETATE, MEGESTROL ACETATE

MELOXICAM, MELOXICAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METHOXSALEN, METHOXSALEN

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NATEGLINIDE, NATEGLINIDE

NEVIRAPINE, NEVIRAPINE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

OLANZAPINE, OLANZAPINE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, POLYETHYLENE GLYCOL

PIROXICAM, PIROXICAM

POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350

POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 184

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* STRIDES PHARMA GLOBAL PTE LTD

POTASSIUM CITRATE, POTASSIUM CITRATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PREDNISONE, PREDNISONE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

ROFLUMILAST, ROFLUMILAST

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, MAGNESIUM SULFATE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TACROLIMUS, TACROLIMUS

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TESTOSTERONE, TESTOSTERONE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TORSEMIDE, TORSEMIDE

TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

URSODIOL, URSODIOL

VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZILEUTON, ZILEUTON

STRONGBRIDGE

* STRONGBRIDGE DUBLIN LTD

RECORLEV, LEVOKETOCONAZOLE

SUCAMPO PHARMA LLC

* SUCAMPO PHARMA AMERICAS LLC

AMITIZA, LUBIPROSTONE

SUMITOMO PHARMA

* SUMITOMO PHARMA SWITZERLAND GMBH

ORGOVYX, RELUGOLIX

SUMITOMO PHARMA AM

* SUMITOMO PHARMA AMERICA INC

APTIOM, ESLICARBAZEPINE ACETATE

SUN PHARM

* SUN PHARMACEUTICAL INDUSTRIES LTD

ABSORICA LD, ISOTRETINOIN

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALPRAZOLAM, ALPRAZOLAM

AMBRISENTAN, AMBRISENTAN

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BICALUTAMIDE, BICALUTAMIDE

BOSENTAN, BOSENTAN

BROMSITE, BROMFENAC SODIUM

BUDESONIDE, BUDESONIDE

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CAFFEINE CITRATE, CAFFEINE CITRATE

CALCITRIOL, CALCITRIOL

CAPECITABINE, CAPECITABINE

CARBIDOPA AND LEVODOPA, CARBIDOPA

CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA

CARBOPLATIN, CARBOPLATIN

CEQUA, CYCLOSPORINE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

CIPROFLOXACIN AND DEXAMETHASONE, CIPROFLOXACIN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 185

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES LTD

DALFAMPRIDINE, DALFAMPRIDINE

DECITABINE, DECITABINE

DEFERASIROX, DEFERASIROX

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DOCETAXEL, DOCETAXEL

DOFETILIDE, DOFETILIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

DROXIDOPA, DROXIDOPA

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

ERTAPENEM SODIUM, ERTAPENEM SODIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM (OTC)

ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM

ESZOPICLONE, ESZOPICLONE

FEBUXOSTAT, FEBUXOSTAT

FENOFIBRATE, FENOFIBRATE

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE

FINASTERIDE, FINASTERIDE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FOSAMPRENAVIR CALCIUM, FOSAMPRENAVIR CALCIUM

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FYREMADEL, GANIRELIX ACETATE

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN HYDROBROMIDE (OTC)

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

IMATINIB MESYLATE, IMATINIB MESYLATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LACOSAMIDE, LACOSAMIDE

LANSOPRAZOLE, LANSOPRAZOLE

LENALIDOMIDE, LENALIDOMIDE

LEUPROLIDE ACETATE, LEUPROLIDE ACETATE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

LORATADINE, LORATADINE (OTC)

LOTEPREDNOL ETABONATE, LOTEPREDNOL ETABONATE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE

NIACIN, NIACIN

NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE

ODOMZO, SONIDEGIB PHOSPHATE

OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS

OMEPRAZOLE, OMEPRAZOLE (OTC)

OPCICON ONE-STEP, LEVONORGESTREL (OTC)

PALIPERIDONE, PALIPERIDONE

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PAZOPANIB HYDROCHLORIDE, PAZOPANIB HYDROCHLORIDE

PREGABALIN, PREGABALIN

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RANOLAZINE, RANOLAZINE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 186

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES LTD

SAXAGLIPTIN, SAXAGLIPTIN HYDROCHLORIDE

SUMATRIPTAN AND NAPROXEN SODIUM, NAPROXEN SODIUM

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

SUNITINIB MALATE, SUNITINIB MALATE

TADALAFIL, TADALAFIL

TEMOZOLOMIDE, TEMOZOLOMIDE

TOBRAMYCIN, TOBRAMYCIN

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VECURONIUM BROMIDE, VECURONIUM BROMIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

WINLEVI, CLASCOTERONE

XELPROS, LATANOPROST

YONSA, ABIRATERONE ACETATE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

SUN PHARM INDS

* SUN PHARMACEUTICAL INDUSTRIES LTD

CARBIDOPA AND LEVODOPA, CARBIDOPA

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLANZAPINE, OLANZAPINE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE

SUN PHARM INDS (IN)

* SUN PHARMACEUTICAL INDUSTRIES LTD

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

ZONISAMIDE, ZONISAMIDE

SUN PHARM INDS INC

* SUN PHARMACEUTICAL INDUSTRIES INC

ABSORICA, ISOTRETINOIN

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMPHETAMINE SULFATE, AMPHETAMINE SULFATE

AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT

CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT

CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT

CLONAZEPAM, CLONAZEPAM

CLOZAPINE, CLOZAPINE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DIGOXIN, DIGOXIN

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, GUAIFENESIN (OTC)

HALOG, HALCINONIDE

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

LITHIUM CARBONATE, LITHIUM CARBONATE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

METOPROLOL TARTRATE, METOPROLOL TARTRATE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

REPAGLINIDE, REPAGLINIDE

SEZABY, PHENOBARBITAL SODIUM

TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT

TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT

TECHNETIUM TC99M MERTIATIDE KIT, TECHNETIUM TC-99M MERTIATIDE KIT

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 187

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES INC

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

SUN PHARM INDS LTD

* SUN PHARMACEUTICAL INDUSTRIES LTD

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

DOXYCYCLINE, DOXYCYCLINE

FAMOTIDINE, FAMOTIDINE (OTC)

FELODIPINE, FELODIPINE

FENOFIBRATE, FENOFIBRATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GLYCOPYRROLATE, GLYCOPYRROLATE

LEVETIRACETAM, LEVETIRACETAM

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)

LORATADINE REDIDOSE, LORATADINE (OTC)

LORATADINE, LORATADINE (OTC)

LORAZEPAM, LORAZEPAM

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE

ONDANSETRON, ONDANSETRON

OXCARBAZEPINE, OXCARBAZEPINE

PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)

RILUZOLE, RILUZOLE

RISPERIDONE, RISPERIDONE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TOPIRAMATE, TOPIRAMATE

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

VALPROIC ACID, VALPROIC ACID

SUN PHARM INDUSTRIES

* SUN PHARMACEUTICAL INDUSTRIES INC

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

BACTRIM DS, SULFAMETHOXAZOLE

BACTRIM, SULFAMETHOXAZOLE

CARVEDILOL PHOSPHATE, CARVEDILOL PHOSPHATE

CHLORTHALIDONE, CHLORTHALIDONE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

ERGOLOID MESYLATES, ERGOLOID MESYLATES

IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 188

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SUN PHARMACEUTICAL INDUSTRIES INC

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NYSTATIN, NYSTATIN

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PINDOLOL, PINDOLOL

PREDNISONE, PREDNISONE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUALAQUIN, QUININE SULFATE

QUINIDINE GLUCONATE, QUINIDINE GLUCONATE

SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

SPIRONOLACTONE, SPIRONOLACTONE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SULINDAC, SULINDAC

TEMAZEPAM, TEMAZEPAM

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE

ULTRAVATE, HALOBETASOL PROPIONATE

SUNNY

* SUNNY PHARMTECH INC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

CARBOPROST TROMETHAMINE, CARBOPROST TROMETHAMINE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

SUNOVION PHARMS INC

* SUNOVION PHARMACEUTICALS INC

LATUDA, LURASIDONE HYDROCHLORIDE

SUNSHINE

* SUNSHINE LAKE PHARMA CO LTD

ARIPIPRAZOLE, ARIPIPRAZOLE

AZITHROMYCIN, AZITHROMYCIN

CLARITHROMYCIN, CLARITHROMYCIN

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ENTACAPONE, ENTACAPONE

FEBUXOSTAT, FEBUXOSTAT

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE, LINAGLIPTIN

LINAGLIPTIN, LINAGLIPTIN

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

RANOLAZINE, RANOLAZINE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TADALAFIL, TADALAFIL

SUPERNUS PHARMS

* SUPERNUS PHARMACEUTICALS INC

OXTELLAR XR, OXCARBAZEPINE

QELBREE, VILOXAZINE HYDROCHLORIDE

TROKENDI XR, TOPIRAMATE

SUVEN PHARMS

* SUVEN PHARMACEUTICALS LTD

CALCIUM ACETATE, CALCIUM ACETATE

CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE

GLYCOPYRROLATE, GLYCOPYRROLATE

MALATHION, MALATHION

SVC PHARMA

* SVC PHARMA LP

DRONABINOL, DRONABINOL

SWEDISH ORPHAN

* SWEDISH ORPHAN BIOVITRUM AB PUBL

ORFADIN, NITISINONE

SYNTHON PHARMS

* SYNTHON PHARMACEUTICALS INC

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

SYNTHON PHARMS INC

* SYNTHON PHARMACEUTICALS INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 189

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** S **

* SYNTHON PHARMACEUTICALS INC

PALBOCICLIB, PALBOCICLIB

** T **

ACME LABS

* THE ACME LABORATORIES LTD

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

METHOCARBAMOL, METHOCARBAMOL

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

GEN HOSP

* THE GENERAL HOSPITAL CORP

AMMONIA N 13, AMMONIA N-13

METHODIST

* THE METHODIST HOSP RESEARCH INSTITUTE

AMMONIA N 13, AMMONIA N-13

METHODIST HOSP RES

* THE METHODIST HOSP RESEARCH INSTITUTE

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

RITEDOSE CORP

* THE RITEDOSE CORP

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

TAGI

* TAGI PHARMA INC

CHLORTHALIDONE, CHLORTHALIDONE

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

METHAZOLAMIDE, METHAZOLAMIDE

TAIHO ONCOLOGY

* TAIHO ONCOLOGY INC

LONSURF, TIPIRACIL HYDROCHLORIDE

LYTGOBI, FUTIBATINIB

TAKEDA PHARMS USA

* TAKEDA PHARMACEUTICALS USA INC

ACTOPLUS MET, METFORMIN HYDROCHLORIDE

ACTOS, PIOGLITAZONE HYDROCHLORIDE

ADDERALL XR 10, AMPHETAMINE ASPARTATE

ADDERALL XR 15, AMPHETAMINE ASPARTATE

ADDERALL XR 20, AMPHETAMINE ASPARTATE

ADDERALL XR 25, AMPHETAMINE ASPARTATE

ADDERALL XR 30, AMPHETAMINE ASPARTATE

ADDERALL XR 5, AMPHETAMINE ASPARTATE

AGRYLIN, ANAGRELIDE HYDROCHLORIDE

ALUNBRIG, BRIGATINIB

CARBATROL, CARBAMAZEPINE

COLCRYS, COLCHICINE

DEXILANT, DEXLANSOPRAZOLE

DUETACT, GLIMEPIRIDE

EXKIVITY, MOBOCERTINIB SUCCINATE

FIRAZYR, ICATIBANT ACETATE

FOSRENOL, LANTHANUM CARBONATE

FRUZAQLA, FRUQUINTINIB

GATTEX KIT, TEDUGLUTIDE RECOMBINANT

ICLUSIG, PONATINIB HYDROCHLORIDE

INTUNIV, GUANFACINE HYDROCHLORIDE

KAZANO, ALOGLIPTIN BENZOATE

LIALDA, MESALAMINE

LIVTENCITY, MARIBAVIR

MOTEGRITY, PRUCALOPRIDE SUCCINATE

MYDAYIS, AMPHETAMINE ASPARTATE

NESINA, ALOGLIPTIN BENZOATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 190

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TAKEDA PHARMACEUTICALS USA INC

NINLARO, IXAZOMIB CITRATE

OSENI, ALOGLIPTIN BENZOATE

PENTASA, MESALAMINE

PREVACID, LANSOPRAZOLE

ROZEREM, RAMELTEON

TRINTELLIX, VORTIOXETINE HYDROBROMIDE

ULORIC, FEBUXOSTAT

VELCADE, BORTEZOMIB

VYVANSE, LISDEXAMFETAMINE DIMESYLATE

TAMARANG

* TAMARANG SA

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

TARO

* TARO PHARMACEUTICAL INDUSTRIES LTD

ACETAMINOPHEN, ACETAMINOPHEN (OTC)

ACETAZOLAMIDE, ACETAZOLAMIDE

AMINOCAPROIC ACID, AMINOCAPROIC ACID

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

BUMETANIDE, BUMETANIDE

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

CARBAMAZEPINE, CARBAMAZEPINE

CARVEDILOL, CARVEDILOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOCORTOLONE PIVALATE, CLOCORTOLONE PIVALATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM

DEFERIPRONE, DEFERIPRONE

DESONIDE, DESONIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM

FELBAMATE, FELBAMATE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOROURACIL, FLUOROURACIL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

GABAPENTIN, GABAPENTIN

GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE

HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

HYDROCORTISONE, HYDROCORTISONE

IMIQUIMOD, IMIQUIMOD

INFANTS' FEVERALL, ACETAMINOPHEN (OTC)

IVERMECTIN, IVERMECTIN (OTC)

KETOCONAZOLE, KETOCONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

MELOXICAM, MELOXICAM

METRONIDAZOLE, METRONIDAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 191

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICAL INDUSTRIES LTD

MINOXIDIL (FOR MEN), MINOXIDIL (OTC)

MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

OXCARBAZEPINE, OXCARBAZEPINE

PHENYTOIN, PHENYTOIN

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TERIL, CARBAMAZEPINE

TOPICORT, DESOXIMETASONE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

WARFARIN SODIUM, WARFARIN SODIUM

* TARO PHARMACEUTICALS INC

ACETIC ACID, ACETIC ACID, GLACIAL

ACYCLOVIR, ACYCLOVIR

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ADAPALENE, ADAPALENE

ADAPALENE, ADAPALENE (OTC)

ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE

AMMONIUM LACTATE, AMMONIUM LACTATE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BUTENAFINE HYDROCHLORIDE, BUTENAFINE HYDROCHLORIDE (OTC)

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

DAPSONE, DAPSONE

DERMABET, BETAMETHASONE VALERATE

DOCOSANOL, DOCOSANOL (OTC)

IBUPROFEN, IBUPROFEN (OTC)

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

OXICONAZOLE NITRATE, OXICONAZOLE NITRATE

TAVABOROLE, TAVABOROLE

TAZAROTENE, TAZAROTENE

TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)

TERCONAZOLE, TERCONAZOLE

TOPICORT, DESOXIMETASONE

TRETINOIN, TRETINOIN

* TARO PHARMACEUTICALS USA INC

AZELAIC ACID, AZELAIC ACID

CICLOPIROX, CICLOPIROX

CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)

DAPSONE, DAPSONE

DESONIDE, DESONIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

ECONAZOLE NITRATE, ECONAZOLE NITRATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

FLUOCINONIDE, FLUOCINONIDE

GENTAMICIN SULFATE, GENTAMICIN SULFATE

HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE

HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE

HYDROCORTISONE, HYDROCORTISONE

IBUPROFEN, IBUPROFEN

IBUPROFEN, IBUPROFEN (OTC)

KETOZOLE, KETOCONAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 192

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TARO PHARMACEUTICALS USA INC

LIDOCAINE, LIDOCAINE

LORATADINE, LORATADINE (OTC)

MICONAZOLE 3, MICONAZOLE NITRATE (OTC)

MOMETASONE FUROATE, MOMETASONE FUROATE

MUPIROCIN, MUPIROCIN

MUPIROCIN, MUPIROCIN CALCIUM

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN

NYSTATIN, NYSTATIN

PHENYTOIN, PHENYTOIN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION

SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM

TERCONAZOLE, TERCONAZOLE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)

TARO PHARM INDS

* TARO PHARMACEUTICAL INDUSTRIES LTD

AMCINONIDE, AMCINONIDE

CARBAMAZEPINE, CARBAMAZEPINE

CICLOPIROX, CICLOPIROX

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE

ETODOLAC, ETODOLAC

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

LAMOTRIGINE, LAMOTRIGINE

TARSUS

* TARSUS PHARMACEUTICALS INC

XDEMVY, LOTILANER

TASMAN PHARMA

* TASMAN PHARMA INC

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

CLOTRIMAZOLE, CLOTRIMAZOLE

FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE

KETOCONAZOLE, KETOCONAZOLE

VERSACLOZ, CLOZAPINE

TCG FLUENT PHARMA

* TCG FLUENT PHARMA INVESTORS LP

FLOLIPID, SIMVASTATIN

TEIKOKU PHARMA USA

* TEIKOKU PHARMA USA INC

LIDODERM, LIDOCAINE

TELIGENT

* TELIGENT PHARMA INC

FLURANDRENOLIDE, FLURANDRENOLIDE

TELIX

* TELIX PHARMACEUTICALS US INC

ILLUCCIX, GALLIUM GA-68 GOZETOTIDE

TENSHI

* TENSHI KAIZEN PVT LTD

LORATADINE, LORATADINE (OTC)

TERSERA

* TERSERA THERAPEUTICS LLC

ERGOMAR, ERGOTAMINE TARTRATE

PRIALT, ZICONOTIDE ACETATE

VARUBI, ROLAPITANT HYDROCHLORIDE

XERMELO, TELOTRISTAT ETIPRATE

ZOLADEX, GOSERELIN ACETATE

TETRAPHASE PHARMS

* TETRAPHASE PHARMACEUTICALS INC

XERAVA, ERAVACYCLINE DIHYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 193

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

TEVA

* TEVA NEUROSCIENCE INC

AUSTEDO XR, DEUTETRABENAZINE

AZILECT, RASAGILINE MESYLATE

UZEDY, RISPERIDONE

* TEVA PHARMACEUTICALS USA INC

ACYCLOVIR, ACYCLOVIR

ADIPEX-P, PHENTERMINE HYDROCHLORIDE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN PEDIATRIC, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

ATENOLOL, ATENOLOL

AZITHROMYCIN, AZITHROMYCIN

BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CALCITRIOL, CALCITRIOL

CARVEDILOL, CARVEDILOL

CEFACLOR, CEFACLOR

CEFPROZIL, CEFPROZIL

CELECOXIB, CELECOXIB

CEPHALEXIN, CEPHALEXIN

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

CILOSTAZOL, CILOSTAZOL

CIMETIDINE, CIMETIDINE

CLEMASTINE FUMARATE, CLEMASTINE FUMARATE

CLONAZEPAM, CLONAZEPAM

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

CLOTRIMAZOLE, CLOTRIMAZOLE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM

DIFLUNISAL, DIFLUNISAL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

EPITOL, CARBAMAZEPINE

ESZOPICLONE, ESZOPICLONE

ETODOLAC, ETODOLAC

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE

FINASTERIDE, FINASTERIDE

FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE

FLUOCINONIDE, FLUOCINONIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLURBIPROFEN, FLURBIPROFEN

FOSINOPRIL SODIUM, FOSINOPRIL SODIUM

GALZIN, ZINC ACETATE

GLYBURIDE (MICRONIZED), GLYBURIDE

GLYBURIDE, GLYBURIDE

IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

KETOCONAZOLE, KETOCONAZOLE

KETOPROFEN, KETOPROFEN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEVOFLOXACIN, LEVOFLOXACIN

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

LOVASTATIN, LOVASTATIN

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE

MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 194

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC

MUPIROCIN, MUPIROCIN

NAPROXEN, NAPROXEN

NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE

NYSTATIN, NYSTATIN

OFLOXACIN, OFLOXACIN

OXAPROZIN, OXAPROZIN

OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE

PENICILLIN-VK, PENICILLIN V POTASSIUM

PIROXICAM, PIROXICAM

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRELONE, PREDNISOLONE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE

SUCRALFATE, SUCRALFATE

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TEVA BRANDED PHARM

* TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

ACTIGALL, URSODIOL

AUSTEDO, DEUTETRABENAZINE

CONDYLOX, PODOFILOX

LOSEASONIQUE, ETHINYL ESTRADIOL

MICROZIDE, HYDROCHLOROTHIAZIDE

NOR-QD, NORETHINDRONE

PROAIR DIGIHALER, ALBUTEROL SULFATE

PROAIR HFA, ALBUTEROL SULFATE

PROAIR RESPICLICK, ALBUTEROL SULFATE

PROGLYCEM, DIAZOXIDE

QNASL, BECLOMETHASONE DIPROPIONATE

QUARTETTE, ETHINYL ESTRADIOL

SEASONALE, ETHINYL ESTRADIOL

SEASONIQUE, ETHINYL ESTRADIOL

ZIAC, BISOPROLOL FUMARATE

TEVA PARENTERAL

* TEVA PARENTERAL MEDICINES INC

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

TEVA PHARM

* TEVA PHARMACEUTICAL INDUSTRIES LTD

AIRDUO DIGIHALER, FLUTICASONE PROPIONATE

AIRDUO RESPICLICK, FLUTICASONE PROPIONATE

ARMONAIR DIGIHALER, FLUTICASONE PROPIONATE

TEVA PHARMS

* TEVA PHARMACEUTICALS DEVELOPMENT INC

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE

PYRIMETHAMINE, PYRIMETHAMINE

* TEVA PHARMACEUTICALS USA

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ANASTROZOLE, ANASTROZOLE

BUDESONIDE, BUDESONIDE

CARBAMAZEPINE, CARBAMAZEPINE

CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE

CEFDINIR, CEFDINIR

CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE

CROMOLYN SODIUM, CROMOLYN SODIUM

FAMCICLOVIR, FAMCICLOVIR

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

IRBESARTAN, IRBESARTAN
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 195

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA

LANSOPRAZOLE, LANSOPRAZOLE

LETROZOLE, LETROZOLE

LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

OXALIPLATIN, OXALIPLATIN

PACLITAXEL, PACLITAXEL

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE

PREGABALIN, PREGABALIN

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

QUININE SULFATE, QUININE SULFATE

RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

VANDAZOLE, METRONIDAZOLE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

TEVA PHARMS INC

* TEVA PHARMACEUTICALS INC

ALVAIZ, ELTROMBOPAG CHOLINE

ALYQ, TADALAFIL

CETRORELIX ACETATE, CETRORELIX ACETATE

PAZOPANIB HYDROCHLORIDE, PAZOPANIB HYDROCHLORIDE

THEOPHYLLINE, THEOPHYLLINE

TEVA PHARMS INTL

* TEVA PHARMACEUTICALS INTERNATIONAL GMBH

AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE

SYNRIBO, OMACETAXINE MEPESUCCINATE

TEVA PHARMS USA

* TEVA PHARMACEUTICALS USA

ACITRETIN, ACITRETIN

ALMOTRIPTAN MALATE, ALMOTRIPTAN MALATE

ARFORMOTEROL TARTRATE, ARFORMOTEROL TARTRATE

ATAZANAVIR SULFATE, ATAZANAVIR SULFATE

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

BEXAROTENE, BEXAROTENE

BLEOMYCIN SULFATE, BLEOMYCIN SULFATE

BUDESONIDE, BUDESONIDE

CLARAVIS, ISOTRETINOIN

CLOZAPINE, CLOZAPINE

COPAXONE, GLATIRAMER ACETATE

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE, EFAVIRENZ

EPTIFIBATIDE, EPTIFIBATIDE

ESTRADIOL, ESTRADIOL

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUVASTATIN SODIUM, FLUVASTATIN SODIUM

FOSAPREPITANT DIMEGLUMINE, FOSAPREPITANT DIMEGLUMINE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

IBUPROFEN AND FAMOTIDINE, FAMOTIDINE

ICOSAPENT ETHYL, ICOSAPENT ETHYL

IMATINIB MESYLATE, IMATINIB MESYLATE

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LANSOPRAZOLE, LANSOPRAZOLE

LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE

LOGILIA, ULIPRISTAL ACETATE

METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE

METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 196

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

OMEPRAZOLE, OMEPRAZOLE

PALONOSETRON HYDROCHLORIDE, PALONOSETRON HYDROCHLORIDE

PARICALCITOL, PARICALCITOL

PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

RISEDRONATE SODIUM, RISEDRONATE SODIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

SUNITINIB MALATE, SUNITINIB MALATE

TADALAFIL, TADALAFIL

TENOFOVIR DISOPROXIL FUMARATE, TENOFOVIR DISOPROXIL FUMARATE

TOBRAMYCIN, TOBRAMYCIN

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TREPROSTINIL, TREPROSTINIL

VIGABATRIN, VIGABATRIN

VILAZODONE HYDROCHLORIDE, VILAZODONE HYDROCHLORIDE

ZANOSAR, STREPTOZOCIN

* TEVA PHARMACEUTICALS USA INC

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ALYQ, TADALAFIL

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

CAPECITABINE, CAPECITABINE

DAPTOMYCIN, DAPTOMYCIN

DARUNAVIR, DARUNAVIR

DEFERASIROX, DEFERASIROX

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

EFINACONAZOLE, EFINACONAZOLE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

EPINEPHRINE (AUTOINJECTOR), EPINEPHRINE

ESTRADIOL, ESTRADIOL

EVEROLIMUS, EVEROLIMUS

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

ICATIBANT ACETATE, ICATIBANT ACETATE

IVERMECTIN, IVERMECTIN

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

MESALAMINE, MESALAMINE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

METRONIDAZOLE, METRONIDAZOLE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

ONSURA, ETHINYL ESTRADIOL

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PENCICLOVIR, PENCICLOVIR

PIRFENIDONE, PIRFENIDONE

TERIFLUNOMIDE, TERIFLUNOMIDE

TERIPARATIDE, TERIPARATIDE

TOBRAMYCIN, TOBRAMYCIN

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

TEVA PHARMS USA INC

* TEVA PHARMACEUTICALS USA INC

CHLORZOXAZONE, CHLORZOXAZONE

CYCLOSPORINE, CYCLOSPORINE

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

ETHINYL ESTRADIOL; ETONOGESTREL, ETHINYL ESTRADIOL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 197

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TEVA PHARMACEUTICALS USA INC

FINZALA, ETHINYL ESTRADIOL

FORMOTEROL FUMARATE, FORMOTEROL FUMARATE

FULVESTRANT, FULVESTRANT

LUBIPROSTONE, LUBIPROSTONE

MIFEPRISTONE, MIFEPRISTONE

NALTREXONE, NALTREXONE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

PLERIXAFOR, PLERIXAFOR

POTASSIUM CITRATE, POTASSIUM CITRATE

RISPERIDONE, RISPERIDONE

SORAFENIB TOSYLATE, SORAFENIB TOSYLATE

TASIMELTEON, TASIMELTEON

TIOPRONIN, TIOPRONIN

TEYRO LABS

* TEYRO LABS PRIVATE LTD

CAPECITABINE, CAPECITABINE

CARBOPLATIN, CARBOPLATIN

GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE

TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE

THE FEINSTEIN INST

* THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

THE J MOLNER

* THE J MOLNER CO OU

DESOXIMETASONE, DESOXIMETASONE

DIFLORASONE DIACETATE, DIFLORASONE DIACETATE

HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE

THEA PHARMA

* THEA PHARMA INC

AKTEN, LIDOCAINE HYDROCHLORIDE

AZASITE, AZITHROMYCIN

BETIMOL, TIMOLOL

COSOPT PF, DORZOLAMIDE HYDROCHLORIDE

COSOPT, DORZOLAMIDE HYDROCHLORIDE

IYUZEH, LATANOPROST

ZIOPTAN, TAFLUPROST

THEPHARMANETWORK LLC

* THEPHARMANETWORK LLC

ISONIAZID, ISONIAZID

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

NIMODIPINE, NIMODIPINE

THERMAZENE, SILVER SULFADIAZINE

THERACOSBIO

* THERACOSBIO LLC

BRENZAVVY, BEXAGLIFLOZIN

THERAGNOSTICS

* THERAGNOSTICS INC

NEPHROSCAN, TECHNETIUM TC-99M SUCCIMER

THERAVIA

* THERAVIA PHARMA

SIKLOS, HYDROXYUREA

THINQ PHARM-CRO PVT

* THINQ PHARMA-CRO PRIVATE LTD

FLUCONAZOLE, FLUCONAZOLE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)

TINIDAZOLE, TINIDAZOLE

TIANJIN KINGYORK

* TIANJIN KINGYORK PHARMACEUTICALS CO LTD

METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE

TIANJIN TIANYAO

* TIANJIN TIANYAO PHARMACEUTICALS CO LTD

CELECOXIB, CELECOXIB
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 198

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TIANJIN TIANYAO PHARMACEUTICALS CO LTD

METHYLPREDNISOLONE, METHYLPREDNISOLONE

TILDE SCIENCES

* TILDE SCIENCES LLC

DARAPRIM, PYRIMETHAMINE

TOLMAR

* TOLMAR INC

ELIGARD KIT, LEUPROLIDE ACETATE

JATENZO, TESTOSTERONE UNDECANOATE

KETOCONAZOLE, KETOCONAZOLE

* TOLMAR INTERNATIONAL LTD

FENSOLVI KIT, LEUPROLIDE ACETATE

TONIX MEDS

* TONIX MEDICINES INC

TOSYMRA, SUMATRIPTAN

ZEMBRACE SYMTOUCH, SUMATRIPTAN SUCCINATE

TOPROL

* TOPROL ACQUISITION LLC

TOPROL-XL, METOPROLOL SUCCINATE

TORPHARM

* TORPHARM INC

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

TORRENT

* TORRENT PHARMA INC

APREPITANT, APREPITANT

DICHLORPHENAMIDE, DICHLORPHENAMIDE

ERYTHROMYCIN, ERYTHROMYCIN

NITISINONE, NITISINONE

* TORRENT PHARMACEUTICALS LTD

ACYCLOVIR, ACYCLOVIR

ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE

ARIPIPRAZOLE, ARIPIPRAZOLE

CELECOXIB, CELECOXIB

DAPSONE, DAPSONE

DARIFENACIN HYDROBROMIDE, DARIFENACIN HYDROBROMIDE

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

FENOFIBRATE (MICRONIZED), FENOFIBRATE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

ITRACONAZOLE, ITRACONAZOLE

LAMOTRIGINE, LAMOTRIGINE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

NEBIVOLOL HYDROCHLORIDE, NEBIVOLOL HYDROCHLORIDE

NYSTATIN, NYSTATIN

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE, AMLODIPINE BESYLATE

PENCICLOVIR, PENCICLOVIR

RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SORAFENIB TOSYLATE, SORAFENIB TOSYLATE

TADALAFIL, TADALAFIL

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TORRENT PHARMS

* TORRENT PHARMACEUTICALS LTD

CARBAMAZEPINE, CARBAMAZEPINE

CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 199

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TORRENT PHARMACEUTICALS LTD

RISPERIDONE, RISPERIDONE

ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE

TORRENT PHARMS LTD

* TORRENT PHARMACEUTICALS LTD

CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE

ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE

FELODIPINE, FELODIPINE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TRAVERE

* TRAVERE THERAPEUTICS INC

FILSPARI, SPARSENTAN

TREVENA

* TREVENA INC

OLINVYK, OLICERIDINE

TRIS PHARMA INC

* TRIS PHARMA INC

DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)

DYANAVEL XR 10, AMPHETAMINE

DYANAVEL XR 15, AMPHETAMINE

DYANAVEL XR 20, AMPHETAMINE

DYANAVEL XR 5, AMPHETAMINE

DYANAVEL XR, AMPHETAMINE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX

IBUPROFEN, IBUPROFEN (OTC)

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

MORPHINE SULFATE, MORPHINE SULFATE

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

THEOPHYLLINE, THEOPHYLLINE

TRUSTEES UNIV PA

* TRUSTEES OF THE UNIV OF PENNSYLVANIA

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

TULEX PHARMS INC

* TULEX PHARMACEUTICALS INC

AMINOCAPROIC ACID, AMINOCAPROIC ACID

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE

NAPROXEN, NAPROXEN

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

TWI PHARMS

* TWI PHARMACEUTICALS INC

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

DEXLANSOPRAZOLE, DEXLANSOPRAZOLE

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIMETHYL FUMARATE, DIMETHYL FUMARATE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FORFIVO XL, BUPROPION HYDROCHLORIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

MEGESTROL ACETATE, MEGESTROL ACETATE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

MYCOPHENOLIC SODIUM, MYCOPHENOLIC SODIUM

NAPRELAN, NAPROXEN SODIUM

NIFEDIPINE, NIFEDIPINE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 200

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** T **

* TWI PHARMACEUTICALS INC

TENORETIC 100, ATENOLOL

TENORETIC 50, ATENOLOL

TENORMIN, ATENOLOL

TERBUTALINE SULFATE, TERBUTALINE SULFATE

TESTOSTERONE, TESTOSTERONE

TOPIRAMATE, TOPIRAMATE

ZESTRIL, LISINOPRIL

TWI PHARMS INC

* TWI PHARMACEUTICALS INC

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

** U **

UBI

* UBI PHARMA INC

CASPOFUNGIN ACETATE, CASPOFUNGIN ACETATE

DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE

VORICONAZOLE, VORICONAZOLE

UCB INC

* UCB INC

BRIVIACT, BRIVARACETAM

FINTEPLA, FENFLURAMINE HYDROCHLORIDE

KEPPRA XR, LEVETIRACETAM

KEPPRA, LEVETIRACETAM

NAYZILAM, MIDAZOLAM

NEUPRO, ROTIGOTINE

VIMPAT, LACOSAMIDE

ZILBRYSQ, ZILUCOPLAN SODIUM

UCLA BIOMEDICAL

* UCLA BIOMEDICAL CYCLOTRON

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UCSF RODIOPHARM

* UCSF RADIOPHARMACEUTICAL FACILITY

AMMONIA N 13, AMMONIA N-13

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UIHC PET IMAGING

* UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

GALLIUM GA 68 EDOTREOTIDE, GALLIUM GA-68 EDOTREOTIDE

ULTRAGENYX PHARM INC

* ULTRAGENYX PHARMACEUTICAL INC

DOJOLVI, TRIHEPTANOIN

UMEDICA

* UMEDICA LABORATORIES PRIVATE LTD

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

CARBAMAZEPINE, CARBAMAZEPINE

CELECOXIB, CELECOXIB

CHLORTHALIDONE, CHLORTHALIDONE

DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM

GLYCOPYRROLATE, GLYCOPYRROLATE

NEOSTIGMINE METHYLSULFATE, NEOSTIGMINE METHYLSULFATE

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

TADALAFIL, TADALAFIL

UNICHEM

* UNICHEM LABORATORIES LTD

ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE

ALLOPURINOL, ALLOPURINOL

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 201

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U **

* UNICHEM LABORATORIES LTD

ARIPIPRAZOLE, ARIPIPRAZOLE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATENOLOL, ATENOLOL

BACLOFEN, BACLOFEN

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

CHLORTHALIDONE, CHLORTHALIDONE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

IRBESARTAN, IRBESARTAN

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

MELOXICAM, MELOXICAM

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

MONTELUKAST SODIUM, MONTELUKAST SODIUM

PIROXICAM, PIROXICAM

PRASUGREL HYDROCHLORIDE, PRASUGREL HYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

RANOLAZINE, RANOLAZINE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TADALAFIL, TADALAFIL

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

ZALEPLON, ZALEPLON

ZONISAMIDE, ZONISAMIDE

UNICHEM LABS LTD

* UNICHEM LABORATORIES LIMITED

DIVALPROEX SODIUM, DIVALPROEX SODIUM

* UNICHEM LABORATORIES LTD

LAMOTRIGINE, LAMOTRIGINE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

UNIMARK REMEDIES LTD

* UNIMARK REMEDIES LTD

MONTELUKAST SODIUM, MONTELUKAST SODIUM

UNIQUE

* UNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD

ATENOLOL, ATENOLOL

CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)

CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

GLIPIZIDE, GLIPIZIDE

LITHIUM CARBONATE, LITHIUM CARBONATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

TOLTERODINE TARTRATE, TOLTERODINE TARTRATE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

UNIQUE PHARM

* UNIQUE PHARMACEUTICAL LABORATORIES

CARBAMAZEPINE, CARBAMAZEPINE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

LORATADINE, LORATADINE (OTC)

UNITED BIOMEDCL

* UNITED BIOMEDICAL INC
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 202

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U **

* UNITED BIOMEDICAL INC

TERBUTALINE SULFATE, TERBUTALINE SULFATE

UNITED GUARDIAN

* UNITED GUARDIAN INC

RENACIDIN, CITRIC ACID

UNITED RES LABS

* UNITED RESEARCH LABORATORIES LLC

BISOPROLOL FUMARATE, BISOPROLOL FUMARATE

OXAZEPAM, OXAZEPAM

UNITED THERAP

* UNITED THERAPEUTICS CORP

ORENITRAM, TREPROSTINIL DIOLAMINE

REMODULIN, TREPROSTINIL

TYVASO DPI, TREPROSTINIL

TYVASO, TREPROSTINIL

UNIV ALAHAMA BIRM

* UNIV ALABAMA AT BIRMINGHAM

AMMONIA N 13, AMMONIA N-13

UNIV CA LOS ANGELES

* UNIV CALIFORNIA LOS ANGELES

GALLIUM GA 68 GOZETOTIDE, GALLIUM GA-68 GOZETOTIDE

UNIV MICHIGAN

* UNIV MICHIGAN PET RADIOPHARMACEUTICAL PRODUCTION PROGRAM

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UNIV OF CA SAN FRAN

* UNIV OF CALIFORNIA SAN FRANCISCO

GALLIUM GA 68 GOZETOTIDE, GALLIUM GA-68 GOZETOTIDE

UNIV SOUTHERN CA

* UNIV SOUTHERN CALIFORNIA DBA USC MOLECULAR IMAGING CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UNIV TX MD ANDERSON

* UNIV TEXAS MD ANDERSON CANCER CENTER

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

UNIV TX SW MEDCTR

* UNIV TEXAS SOUTHWESTERN MEDCTR

AMMONIA N 13, AMMONIA N-13

UNIV UTAH CYCLOTRON

* UNIV UTAH CYCLOTRON RADIOCHEMISTRY LAB

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18

UNIV WISCONSIN

* UNIV WISCONSIN SYSTEM

AMMONIA N 13, AMMONIA N-13

UPJOHN

* UPJOHN MANUFACTURING IRELAND UNLTD

LIPITOR, ATORVASTATIN CALCIUM

RELPAX, ELETRIPTAN HYDROBROMIDE

* UPJOHN US 2 LLC

CELEBREX, CELECOXIB

DETROL LA, TOLTERODINE TARTRATE

DETROL, TOLTERODINE TARTRATE

EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE

INSPRA, EPLERENONE

LYRICA CR, PREGABALIN

LYRICA, PREGABALIN

XALATAN, LATANOPROST

XANAX XR, ALPRAZOLAM

XANAX, ALPRAZOLAM

UPSHER SMITH LABS

* UPSHER SMITH LABORATORIES LLC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BACLOFEN, BACLOFEN

BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 203

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U **

* UPSHER SMITH LABORATORIES LLC

BEXAROTENE, BEXAROTENE

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, BRIMONIDINE TARTRATE

BUMETANIDE, BUMETANIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CHLORZOXAZONE, CHLORZOXAZONE

CLOBAZAM, CLOBAZAM

DIVALPROEX SODIUM, DIVALPROEX SODIUM

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DROXIDOPA, DROXIDOPA

ELIGLUSTAT TARTRATE, ELIGLUSTAT TARTRATE

ETHACRYNIC ACID, ETHACRYNIC ACID

EXEMESTANE, EXEMESTANE

FAMOTIDINE, FAMOTIDINE

FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE

HALOPERIDOL, HALOPERIDOL

ISOTRETINOIN, ISOTRETINOIN

JANTOVEN, WARFARIN SODIUM

KLOR-CON M10, POTASSIUM CHLORIDE

KLOR-CON M15, POTASSIUM CHLORIDE

KLOR-CON M20, POTASSIUM CHLORIDE

KLOR-CON, POTASSIUM CHLORIDE

LAMIVUDINE, LAMIVUDINE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MIRTAZAPINE, MIRTAZAPINE

MORPHINE SULFATE, MORPHINE SULFATE

MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE

MYORISAN, ISOTRETINOIN

NYSTATIN, NYSTATIN

ORVATEN, MIDODRINE HYDROCHLORIDE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PACERONE, AMIODARONE HYDROCHLORIDE

PREVALITE, CHOLESTYRAMINE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

QUDEXY XR, TOPIRAMATE

RAMELTEON, RAMELTEON

SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE

VIGABATRIN, VIGABATRIN

VOGELXO, TESTOSTERONE

URL LABS

* URL LABORATORIES LLC

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

UROGEN PHARMA

* UROGEN PHARMA LTD

JELMYTO, MITOMYCIN

UROVANT

* UROVANT SCIENCES GMBH

GEMTESA, VIBEGRON

US ANTIBIOTICS

* US ANTIBIOTICS LLC

AMOXIL, AMOXICILLIN

AUGMENTIN '125', AMOXICILLIN

AUGMENTIN '250', AMOXICILLIN

AUGMENTIN '875', AMOXICILLIN

AUGMENTIN ES-600, AMOXICILLIN

LAROTID, AMOXICILLIN

USPHARMA

* USPHARMA LTD

NITRO-DUR, NITROGLYCERIN

USPHARMA WINDLAS

* USPHARMA WINDLAS LLC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

USV
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 204

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** U **

* USV PRIVATE LTD

OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE (OTC)

ZOLEDRONIC ACID, ZOLEDRONIC ACID

USWM

* USWM LLC

CORGARD, NADOLOL

IWILFIN, EFLORNITHINE HYDROCHLORIDE

LUCEMYRA, LOFEXIDINE HYDROCHLORIDE

REVONTO, DANTROLENE SODIUM

** V **

VALEANT

* VALEANT PHARMACEUTICALS INTERNATIONAL

BONTRIL PDM, PHENDIMETRAZINE TARTRATE

MYSOLINE, PRIMIDONE

VALEANT BERMUDA

* VALEANT INTERNATIONAL BERMUDA

RETIN-A, TRETINOIN

VALEANT INTL

* VALEANT INTERNATIONAL BARBADOS SRL

RETIN-A, TRETINOIN

* VALEANT INTERNATIONAL SRL

BENZAMYCIN, BENZOYL PEROXIDE

VALEANT LUXEMBOURG

* VALEANT PHARMACEUTICALS LUXEMBOURG SARL

TARGRETIN, BEXAROTENE

VISUDYNE, VERTEPORFIN

VALEANT PHARM INTL

* VALEANT PHARMACEUTICALS INTERNATIONAL

ANDROID 25, METHYLTESTOSTERONE

LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE

VALEANT PHARMS

* VALEANT PHARMACEUTICALS NORTH AMERICA LLC

PENTOXIFYLLINE, PENTOXIFYLLINE

VALEANT PHARMS INTL

* VALEANT PHARMACEUTICALS INTERNATIONAL

COLAZAL, BALSALAZIDE DISODIUM

CUPRIMINE, PENICILLAMINE

VALEANT PHARMS NORTH

* VALEANT PHARMACEUTICALS NORTH AMERICA LLC

CARAC, FLUOROURACIL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

FENOFIBRATE, FENOFIBRATE

NIFEDIPINE, NIFEDIPINE

RENOVA, TRETINOIN

RETIN-A, TRETINOIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VALIDUS PHARMS

* VALIDUS PHARMACEUTICALS LLC

ANZEMET, DOLASETRON MESYLATE

BUMEX, BUMETANIDE

EQUETRO, CARBAMAZEPINE

LASIX, FUROSEMIDE

LOPRESSOR HCT, HYDROCHLOROTHIAZIDE

LOPRESSOR, METOPROLOL TARTRATE

LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE

LOTENSIN, BENAZEPRIL HYDROCHLORIDE

NORPRAMIN, DESIPRAMINE HYDROCHLORIDE

VALIDUS PHARMS INC

* VALIDUS PHARMACEUTICALS INC

MARPLAN, ISOCARBOXAZID

VALINOR

* VALINOR PHARMA LLC

MOVANTIK, NALOXEGOL OXALATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 205

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V **

VANCOCIN ITALIA

* VANCOCIN ITALIA SRL

MULPLETA, LUSUTROMBOPAG

VANDA PHARMS INC

* VANDA PHARMACEUTICALS INC

FANAPT, ILOPERIDONE

HETLIOZ LQ, TASIMELTEON

HETLIOZ, TASIMELTEON

VELOXIS PHARMS INC

* VELOXIS PHARMACEUTICALS INC

ENVARSUS XR, TACROLIMUS

VERITY

* VERITY PHARMACEUTICALS INC

TRELSTAR, TRIPTORELIN PAMOATE

VERO BIOTECH INC

* VERO BIOTECH INC

GENOSYL, NITRIC OXIDE

VEROSCIENCE

* VEROSCIENCE LLC

CYCLOSET, BROMOCRIPTINE MESYLATE

VERRICA PHARMS

* VERRICA PHARMACEUTICALS INC

YCANTH, CANTHARIDIN

VERTEX PHARMS

* VERTEX PHARMACEUTICALS INC

KALYDECO, IVACAFTOR

VERTEX PHARMS INC

* VERTEX PHARMACEUTICALS INC

KALYDECO, IVACAFTOR

ORKAMBI, IVACAFTOR

SYMDEKO (COPACKAGED), IVACAFTOR

TRIKAFTA (COPACKAGED), ELEXACAFTOR, IVACAFTOR, TEZACAFTOR

VERTICAL PHARMS

* VERTICAL PHARMACEUTICALS LLC

DIVIGEL, ESTRADIOL

DSUVIA, SUFENTANIL CITRATE

VIATRIS

* VIATRIS SPECIALTY LLC

CARDURA XL, DOXAZOSIN MESYLATE

CARDURA, DOXAZOSIN MESYLATE

DILANTIN, PHENYTOIN SODIUM

DILANTIN-125, PHENYTOIN

GEODON, ZIPRASIDONE HYDROCHLORIDE

GEODON, ZIPRASIDONE MESYLATE

NEURONTIN, GABAPENTIN

NITROSTAT, NITROGLYCERIN

NORVASC, AMLODIPINE BESYLATE

REVATIO, SILDENAFIL CITRATE

VIAGRA, SILDENAFIL CITRATE

ZOLOFT, SERTRALINE HYDROCHLORIDE

VICURON HOLDINGS

* VICURON HOLDINGS LLC

ERAXIS, ANIDULAFUNGIN

VIFOR FRESENIUS

* VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE

VELPHORO, FERRIC OXYHYDROXIDE

VIFOR PHARMA

* VIFOR PHARMA INC

VELTASSA, PATIROMER SORBITEX CALCIUM

VIIV HLTHCARE

* VIIV HEALTHCARE CO

APRETUDE, CABOTEGRAVIR

CABENUVA KIT, CABOTEGRAVIR

COMBIVIR, LAMIVUDINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 206

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V **

* VIIV HEALTHCARE CO

DOVATO, DOLUTEGRAVIR SODIUM

EPIVIR, LAMIVUDINE

EPZICOM, ABACAVIR SULFATE

JULUCA, DOLUTEGRAVIR SODIUM

LEXIVA, FOSAMPRENAVIR CALCIUM

RETROVIR, ZIDOVUDINE

RUKOBIA, FOSTEMSAVIR TROMETHAMINE

SELZENTRY, MARAVIROC

TIVICAY PD, DOLUTEGRAVIR SODIUM

TIVICAY, DOLUTEGRAVIR SODIUM

TRIUMEQ PD, ABACAVIR SULFATE

TRIUMEQ, ABACAVIR SULFATE

VOCABRIA, CABOTEGRAVIR SODIUM

ZIAGEN, ABACAVIR SULFATE

VINTAGE

* VINTAGE PHARMACEUTICALS LLC

BENZTROPINE MESYLATE, BENZTROPINE MESYLATE

DUTASTERIDE, DUTASTERIDE

VINTAGE PHARMS

* VINTAGE PHARMACEUTICALS

GILDAGIA, ETHINYL ESTRADIOL

GILDESS 24 FE, ETHINYL ESTRADIOL

KIMIDESS, DESOGESTREL

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

* VINTAGE PHARMACEUTICALS INC

ALLOPURINOL, ALLOPURINOL

BACLOFEN, BACLOFEN

IBUPROFEN, IBUPROFEN (OTC)

METHYLPREDNISOLONE, METHYLPREDNISOLONE

PERPHENAZINE, PERPHENAZINE

PREDNISONE, PREDNISONE

VINTAGE PHARMS LLC

* VINTAGE PHARMACEUTICALS LLC

FELODIPINE, FELODIPINE

MYZILRA, ETHINYL ESTRADIOL

PERCOCET, ACETAMINOPHEN

PREVIFEM, ETHINYL ESTRADIOL

VIRTUS

* VIRTUS PHARMACEUTICALS LLC

CROMOLYN SODIUM, CROMOLYN SODIUM

LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE

PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE

PROMETRIUM, PROGESTERONE

VIRTUS PHARM

* VIRTUS PHARMACEUTICAL INC

ACARBOSE, ACARBOSE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

VISTA PHARMS

* VISTA PHARMACEUTICALS INC

SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE

VISTAPHARM

* VISTAPHARM INC

ARIPIPRAZOLE, ARIPIPRAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

PHENYTOIN, PHENYTOIN

SUCRALFATE, SUCRALFATE

VISUM PHARM

* VISUM PHARMACEUTICAL CO LTD

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

VITRUVIAS

* VITRUVIAS THERAPEUTICS INC

ENTECAVIR, ENTECAVIR
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 207

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** V **

VITRUVIAS THERAP

* VITRUVIAS THERAPEUTICS LLC

CYANOCOBALAMIN, CYANOCOBALAMIN

VIVUS

* VIVUS INC

QSYMIA, PHENTERMINE HYDROCHLORIDE

VIWIT PHARM

* VIWIT PHARMACEUTICAL CO LTD

LEVETIRACETAM, LEVETIRACETAM

PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE

SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

VKT PHARMA

* VKT PHARMA PRIVATE LTD

FAMOTIDINE, FAMOTIDINE (OTC)

RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE

RANOLAZINE, RANOLAZINE

TADALAFIL, TADALAFIL

VPI PHARMS INC

* VPI PHARMACEUTICALS INC

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

VPNA

* VALEANT PHARMACEUTICALS NORTH AMERICA

DICLOFENAC SODIUM, DICLOFENAC SODIUM

** W **

WA UNIV SCH MED

* WASHINGTON UNIV SCHOOL MEDICINE

AMMONIA N 13, AMMONIA N-13

WANBANG BIOPHARMS

* WANBANG BIOPHARMACEUTICALS

CARISOPRODOL, CARISOPRODOL

LEFLUNOMIDE, LEFLUNOMIDE

WATSON LABS

* WATSON LABORATORIES

FOLIC ACID, FOLIC ACID

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

* WATSON LABORATORIES INC

ACARBOSE, ACARBOSE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALENDRONATE SODIUM, ALENDRONATE SODIUM

ALLOPURINOL, ALLOPURINOL

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

AMOXAPINE, AMOXAPINE

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

CARISOPRODOL, CARISOPRODOL

CHLORZOXAZONE, CHLORZOXAZONE

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

COL-PROBENECID, COLCHICINE

DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE

ESTAZOLAM, ESTAZOLAM

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE, GLIPIZIDE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LAMOTRIGINE, LAMOTRIGINE

LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LISINOPRIL, LISINOPRIL

LORAZEPAM, LORAZEPAM

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

LOXAPINE SUCCINATE, LOXAPINE SUCCINATE

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METRONIDAZOLE, METRONIDAZOLE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 208

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MINOXIDIL, MINOXIDIL

NABUMETONE, NABUMETONE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE

NATEGLINIDE, NATEGLINIDE

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NIZATIDINE, NIZATIDINE

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

ORPHENADRINE CITRATE, ORPHENADRINE CITRATE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PREDNISOLONE, PREDNISOLONE

PREDNISONE, PREDNISONE

PRIMIDONE, PRIMIDONE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

QUASENSE, ETHINYL ESTRADIOL

RAMIPRIL, RAMIPRIL

RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE

SULFASALAZINE, SULFASALAZINE

SULINDAC, SULINDAC

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE

TRIMETHOPRIM, TRIMETHOPRIM

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

ZOVIA 1/50E-28, ETHINYL ESTRADIOL

* WATSON LABS INC

LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

WATSON LABS INC

* WATSON LABORATORIES INC

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMBRISENTAN, AMBRISENTAN

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE

BOSENTAN, BOSENTAN

BRINZOLAMIDE, BRINZOLAMIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

CELECOXIB, CELECOXIB

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

COLCHICINE, COLCHICINE

DICLOFENAC SODIUM, DICLOFENAC SODIUM

DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, DROSPIRENONE

EZETIMIBE AND SIMVASTATIN, EZETIMIBE

EZETIMIBE, EZETIMIBE

METRONIDAZOLE, METRONIDAZOLE

MODAFINIL, MODAFINIL

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN

PENICILLAMINE, PENICILLAMINE

PERPHENAZINE, PERPHENAZINE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

SILDENAFIL CITRATE, SILDENAFIL CITRATE

SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE

TADALAFIL, TADALAFIL

WATSON LABS TEVA

* WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

ALVIMOPAN, ALVIMOPAN

BICALUTAMIDE, BICALUTAMIDE

BUPRENORPHINE, BUPRENORPHINE

CINACALCET HYDROCHLORIDE, CINACALCET HYDROCHLORIDE

GLIPIZIDE, GLIPIZIDE

IBANDRONATE SODIUM, IBANDRONATE SODIUM

ISRADIPINE, ISRADIPINE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 209

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL

NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

PROBENECID, PROBENECID

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

WATSON PHARMS INC

* WATSON PHARMACEUTICALS INC

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE

WAVERLEY PHARMA INC

* WAVERLEY PHARMA INC

BORTEZOMIB, BORTEZOMIB

PEMETREXED DISODIUM, PEMETREXED DISODIUM

WAYLIS THERAP

* WAYLIS THERAPEUTICS LLC

FLUTAMIDE, FLUTAMIDE

LEUKERAN, CHLORAMBUCIL

MYLERAN, BUSULFAN

THIOGUANINE, THIOGUANINE

VALIUM, DIAZEPAM

WES PHARMA INC

* WES PHARMA INC

ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE

HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN

METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE

OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

WEST WARD

* WEST WARD PHARMACEUTICAL CORP

DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE

WEST WARD PHARM CORP

* WEST WARD PHARMACEUTICAL CORP

ROCURONIUM BROMIDE, ROCURONIUM BROMIDE

WEST-WARD PHARMS INT

* WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD

BUMETANIDE, BUMETANIDE

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYTARABINE, CYTARABINE

DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE

DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE

DIGOXIN, DIGOXIN

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE

DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

INDOMETHACIN SODIUM, INDOMETHACIN SODIUM

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE

OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE

OCTREOTIDE ACETATE, OCTREOTIDE ACETATE

PENTOSTATIN, PENTOSTATIN

PHENYTOIN SODIUM, PHENYTOIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, FERRIC OXYHYDROXIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 210

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD

THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE

THIOTEPA, THIOTEPA

WESTMINSTER PHARMS

* WESTMINSTER PHARMACEUTICALS LLC

EPLERENONE, EPLERENONE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MIGLITOL, MIGLITOL

POSACONAZOLE, POSACONAZOLE

RISPERIDONE, RISPERIDONE

WILSHIRE PHARMS INC

* WILSHIRE PHARMACEUTICALS INC

CARISOPRODOL, CARISOPRODOL

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

PERPHENAZINE, PERPHENAZINE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

WINDER LABS LLC

* WINDER LABORATOIRIES LLC

DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE

WISCONSIN

* WISCONSIN MEDICAL RADIOPHARMACY LLC

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

WOCKHARDT

* WOCKHARDT LTD

CAPTOPRIL, CAPTOPRIL

CEFTRIAXONE, CEFTRIAXONE SODIUM

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)

FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)

FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM

FUROSEMIDE, FUROSEMIDE

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LANSOPRAZOLE, LANSOPRAZOLE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE

ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE

SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

WOCKHARDT BIO AG

* WOCKHARDT BIO AG

ABIRATERONE ACETATE, ABIRATERONE ACETATE

ACETAMINOPHEN, ACETAMINOPHEN

AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN

AMOXICILLIN, AMOXICILLIN

BROMFED-DM, BROMPHENIRAMINE MALEATE

CROMOLYN SODIUM, CROMOLYN SODIUM

DECITABINE, DECITABINE

ENTACAPONE, ENTACAPONE

GENERLAC, LACTULOSE

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE

LAMOTRIGINE, LAMOTRIGINE

LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE

LISINOPRIL, LISINOPRIL

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)

LORATADINE, LORATADINE (OTC)

NYSTATIN, NYSTATIN

OXACILLIN SODIUM, OXACILLIN SODIUM

PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM

PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE

PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE

PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 211

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** W **

* WOCKHARDT BIO AG

TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

WOCKHARDT LTD

* WOCKHARDT LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

ENALAPRIL MALEATE, ENALAPRIL MALEATE

WOODWARD

* WOODWARD PHARMA SERVICES LLC

ACIPHEX, RABEPRAZOLE SODIUM

AVODART, DUTASTERIDE

COREG CR, CARVEDILOL PHOSPHATE

COREG, CARVEDILOL

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE

JALYN, DUTASTERIDE

LOVAZA, OMEGA-3-ACID ETHYL ESTERS

LUNESTA, ESZOPICLONE

MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE

MIVACURIUM CHLORIDE, MIVACURIUM CHLORIDE

WRASER PHARMS

* WRASER PHARMACEUTICALS LLC

CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE

WUSM CYCLOTRON

* WASHINGTON UNIV SCH MEDICINE CYCLOTRON FACILITY

FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18

WYETH PHARMS

* WYETH PHARMACEUTICALS LLC

DUAVEE, BAZEDOXIFENE ACETATE

PREMARIN, ESTROGENS, CONJUGATED

PREMPHASE 14/14, ESTROGENS, CONJUGATED

PREMPRO, ESTROGENS, CONJUGATED

PROTONIX IV, PANTOPRAZOLE SODIUM

PROTONIX, PANTOPRAZOLE SODIUM

TRECATOR, ETHIONAMIDE

** X **

X-GEN PHARMS INC

* X-GEN PHARMACEUTICALS INC

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

XELLIA PHARMS APS

* XELLIA PHARMACEUTICALS APS

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

DAPTOMYCIN, DAPTOMYCIN

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

POLYMYXIN B SULFATE, POLYMYXIN B SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

XERIS

* XERIS PHARMACEUTICALS INC

GVOKE HYPOPEN, GLUCAGON

GVOKE KIT, GLUCAGON

GVOKE PFS, GLUCAGON

KEVEYIS, DICHLORPHENAMIDE

XGEN PHARMS

* XGEN PHARMACEUTICALS DJB INC

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

AMPHOTERICIN B, AMPHOTERICIN B

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DACTINOMYCIN, DACTINOMYCIN

FOLIC ACID, FOLIC ACID

IBUPROFEN LYSINE, IBUPROFEN LYSINE

LINCOMYCIN HYDROCHLORIDE, LINCOMYCIN HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 212

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** X **

* XGEN PHARMACEUTICALS DJB INC

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE

NEOMYCIN SULFATE, NEOMYCIN SULFATE

PENTAMIDINE ISETHIONATE, PENTAMIDINE ISETHIONATE

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE

TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE

TRANEXAMIC ACID, TRANEXAMIC ACID

XIAMEN LP PHARM CO

* XIAMEN LP PHARMACUETICAL CO LTD

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

XIROMED

* XIROMED PHARMA ESPANA SL

ACYCLOVIR, ACYCLOVIR

ALTAVERA, ETHINYL ESTRADIOL

BETAMETHASONE VALERATE, BETAMETHASONE VALERATE

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

ENILLORING, ETHINYL ESTRADIOL

EPHEDRINE SULFATE, EPHEDRINE SULFATE

ESTARYLLA, ETHINYL ESTRADIOL

ESTRADIOL VALERATE, ESTRADIOL VALERATE

FLUOCINONIDE, FLUOCINONIDE

FOSFOMYCIN TROMETHAMINE, FOSFOMYCIN TROMETHAMINE

FULVESTRANT, FULVESTRANT

GEMMILY, ETHINYL ESTRADIOL

GLYCOPYRROLATE, GLYCOPYRROLATE

INTROVALE, ETHINYL ESTRADIOL

ISIBLOOM, DESOGESTREL

JAIMIESS, ETHINYL ESTRADIOL

KETOCONAZOLE, KETOCONAZOLE

LANSOPRAZOLE, LANSOPRAZOLE

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL

LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

LEVONORGESTREL, LEVONORGESTREL (OTC)

LORYNA, DROSPIRENONE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

NAFTIFINE HYDROCHLORIDE, NAFTIFINE HYDROCHLORIDE

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL

OMEPRAZOLE, OMEPRAZOLE

PROGESTERONE, PROGESTERONE

RAMELTEON, RAMELTEON

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE

SYEDA, DROSPIRENONE

TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE

TESTOSTERONE, TESTOSTERONE

TRI-ESTARYLLA, ETHINYL ESTRADIOL

TRI-LO-ESTARYLLA, ETHINYL ESTRADIOL

VIENVA, ETHINYL ESTRADIOL

VOLNEA, DESOGESTREL

XSPIRE PHARMA

* XSPIRE PHARMA

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN

NALFON, FENOPROFEN CALCIUM

TREZIX, ACETAMINOPHEN

ZONTIVITY, VORAPAXAR SULFATE

* XSPIRE PHARMA LLC

DEXAMETHASONE, DEXAMETHASONE

FENOPROFEN CALCIUM, FENOPROFEN CALCIUM

XTTRIUM

* XTTRIUM LABORATORIES INC

CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE

EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 213

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** X **

XTTRIUM LABS INC

* XTTRIUM LABORATORIES INC

LACTULOSE, LACTULOSE

** Y **

YABAO PHARM

* YABAO PHARMACEUTICAL CO LTD BEIJING

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

SORAFENIB TOSYLATE, SORAFENIB TOSYLATE

YAOPHARMA CO LTD

* YAOPHARMA CO LTD

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

YICHANG HUMANWELL

* YICHANG HUMANWELL PHARMACEUTICAL CO LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE

FENOFIBRIC ACID, CHOLINE FENOFIBRATE

FLECAINIDE ACETATE, FLECAINIDE ACETATE

GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE

IBUPROFEN, IBUPROFEN

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

YILING

* YILING PHARMACEUTICAL LTD

ACYCLOVIR, ACYCLOVIR

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CELECOXIB, CELECOXIB

CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE

FELODIPINE, FELODIPINE

LAMOTRIGINE, LAMOTRIGINE

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PREGABALIN, PREGABALIN

VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE

YOUNGTECH PHARMS INC

* YOUNGTECH PHARMACEUTICALS INC

METOPROLOL TARTRATE, METOPROLOL TARTRATE

YUNG SHIN PHARM

* YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD

AZITHROMYCIN, AZITHROMYCIN

CEFACLOR, CEFACLOR

CEPHALEXIN, CEPHALEXIN

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM

FELODIPINE, FELODIPINE

MELOXICAM, MELOXICAM

** Z **

ZAMBON SPA

* ZAMBON SPA ITALY

MONUROL, FOSFOMYCIN TROMETHAMINE

ZEALAND PHARMA

* ZEALAND PHARMA US INC

ZEGALOGUE (AUTOINJECTOR), DASIGLUCAGON HYDROCHLORIDE

ZEGALOGUE, DASIGLUCAGON HYDROCHLORIDE

ZENNOVA

* ZENNOVA PHARMACEUTICALS CHENGDU CO LTD

IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

QUETIAPINE FUMARATE, QUETIAPINE FUMARATE

ZHEJIANG HISUN PHARM
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 214

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z **

* ZHEJIANG HISUN PHARMACEUTICAL CO LTD

MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL

ZHEJIANG JINGXIN

* ZHEJIANG JINGXIN PHARMACEUTICAL CO LTD

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

LEVETIRACETAM, LEVETIRACETAM

ZHEJIANG JIUZHOU

* ZHEJIANG JIUZHOU BIOPHARMA CO LTD

CARBAMAZEPINE, CARBAMAZEPINE

ZHEJIANG JUTAI PHARM

* ZHEJIANG JUTAI PHARMACEUTICAL CO LTD

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

ZHEJIANG NOVUS PHARM

* ZHEJIANG NOVUS PHARMACEUTICALS CO LTD

VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE

ZHEJIANG YONGTAI

* ZHEJIANG YONGTAI PHARMACEUTICAL CO LTD

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

GABAPENTIN, GABAPENTIN

ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM

ZR PHARMA

* ZR PHARMA AND GMBH

RUBRACA, RUCAPARIB CAMSYLATE

ZUREX PHARMA

* ZUREX PHARMA

ZURAGARD, ISOPROPYL ALCOHOL (OTC)

ZYDUS

* ZYDUS WORLDWIDE DMCC

ACETAZOLAMIDE, ACETAZOLAMIDE

AZITHROMYCIN, AZITHROMYCIN

BACLOFEN, BACLOFEN

BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM

CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE

ERYTHROMYCIN, ERYTHROMYCIN

FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE

ICOSAPENT ETHYL, ICOSAPENT ETHYL

INDOMETHACIN, INDOMETHACIN

ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE

IVERMECTIN, IVERMECTIN

KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE

LEFLUNOMIDE, LEFLUNOMIDE

LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM

MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE

METHYLENE BLUE, METHYLENE BLUE

MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE (OTC)

OXCARBAZEPINE, OXCARBAZEPINE

PHYTONADIONE, PHYTONADIONE

PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE

PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE

SILDENAFIL CITRATE, SILDENAFIL CITRATE

TOPIRAMATE, TOPIRAMATE

URSODIOL, URSODIOL

VARENICLINE TARTRATE, VARENICLINE TARTRATE

VIGABATRIN, VIGABATRIN

ZITUVIMET, METFORMIN HYDROCHLORIDE

ZITUVIO, SITAGLIPTIN

ZYDUS HLTHCARE

* ZYDUS HEALTHCARE USA LLC

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE

LANSOPRAZOLE, LANSOPRAZOLE

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 215

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z **

ZYDUS LIFESCIENCES

* ZYDUS LIFESCIENCES LTD

ACYCLOVIR, ACYCLOVIR

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL

CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL

CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE

CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE

DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE

FEBUXOSTAT, FEBUXOSTAT

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE

METRONIDAZOLE, METRONIDAZOLE

SUCRALFATE, SUCRALFATE

TAVABOROLE, TAVABOROLE

ZYDUS NOVELTECH INC

* ZYDUS NOVELTECH INC

ETHINYL ESTRADIOL AND NORELGESTROMIN, ETHINYL ESTRADIOL

ZYDUS PHARMS

* ZYDUS PHARMACEUTICALS USA INC

ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM

ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM

ACETYLCYSTEINE, ACETYLCYSTEINE

ACYCLOVIR SODIUM, ACYCLOVIR SODIUM

ACYCLOVIR, ACYCLOVIR

ADAPALENE AND BENZOYL PEROXIDE, ADAPALENE

ALBENDAZOLE, ALBENDAZOLE

ALBUTEROL SULFATE, ALBUTEROL SULFATE

ALLOPURINOL, ALLOPURINOL

AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE

AMBRISENTAN, AMBRISENTAN

AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE

AMLODIPINE AND OLMESARTAN MEDOXOMIL, AMLODIPINE BESYLATE

AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE

ARSENIC TRIOXIDE, ARSENIC TRIOXIDE

ASPIRIN AND DIPYRIDAMOLE, ASPIRIN

ATENOLOL AND CHLORTHALIDONE, ATENOLOL

ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM

AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE

BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE

BORTEZOMIB, BORTEZOMIB

BOSENTAN, BOSENTAN

BUDESONIDE, BUDESONIDE

BUMETANIDE, BUMETANIDE

BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE

BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE

CARBAMAZEPINE, CARBAMAZEPINE

CARBIDOPA, CARBIDOPA

CHLORTHALIDONE, CHLORTHALIDONE

CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE

CHOLESTYRAMINE, CHOLESTYRAMINE

CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE

CLOBAZAM, CLOBAZAM

CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE

CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE

COLCHICINE, COLCHICINE

COLESEVELAM HYDROCHLORIDE, COLESEVELAM HYDROCHLORIDE

COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE

CYANOCOBALAMIN, CYANOCOBALAMIN

CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE

DARUNAVIR, DARUNAVIR

DECITABINE, DECITABINE

DEFERASIROX, DEFERASIROX

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE

DESVENLAFAXINE SUCCINATE, DESVENLAFAXINE SUCCINATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 216

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z **

* ZYDUS PHARMACEUTICALS USA INC

DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE

DIFLUNISAL, DIFLUNISAL

DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE

DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE

DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE

DOXYCYCLINE, DOXYCYCLINE

DOXYCYCLINE, DOXYCYCLINE HYCLATE

DROXIDOPA, DROXIDOPA

DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE

ELETRIPTAN HYDROBROMIDE, ELETRIPTAN HYDROBROMIDE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE

ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM

ENTECAVIR, ENTECAVIR

ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM

ESTRADIOL, ESTRADIOL

ETHACRYNATE SODIUM, ETHACRYNATE SODIUM

ETODOLAC, ETODOLAC

ETOMIDATE, ETOMIDATE

EXEMESTANE, EXEMESTANE

EZETIMIBE, EZETIMIBE

FAMOTIDINE, FAMOTIDINE

FESOTERODINE FUMARATE, FESOTERODINE FUMARATE

FINGOLIMOD HYDROCHLORIDE, FINGOLIMOD HYDROCHLORIDE

FLUCONAZOLE, FLUCONAZOLE

FLUOCINONIDE, FLUOCINONIDE

FULVESTRANT, FULVESTRANT

GLIPIZIDE, GLIPIZIDE

GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE

GLYBURIDE, GLYBURIDE

HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE

IMATINIB MESYLATE, IMATINIB MESYLATE

INDOMETHACIN, INDOMETHACIN

ISOTRETINOIN, ISOTRETINOIN

ITRACONAZOLE, ITRACONAZOLE

IVABRADINE HYDROCHLORIDE, IVABRADINE HYDROCHLORIDE

LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE

LACOSAMIDE, LACOSAMIDE

LAMOTRIGINE, LAMOTRIGINE

LANSOPRAZOLE, LANSOPRAZOLE

LENALIDOMIDE, LENALIDOMIDE

LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM

LINEZOLID, LINEZOLID

LUBIPROSTONE, LUBIPROSTONE

LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE

MEMANTINE HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE

MESALAMINE, MESALAMINE

METHOTREXATE SODIUM, METHOTREXATE SODIUM

METHYLPREDNISOLONE, METHYLPREDNISOLONE

METOPROLOL SUCCINATE, METOPROLOL SUCCINATE

MICAFUNGIN SODIUM, MICAFUNGIN SODIUM

MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL HYDROCHLORIDE

NADOLOL, NADOLOL

NATEGLINIDE, NATEGLINIDE

NELARABINE, NELARABINE

NIFEDIPINE, NIFEDIPINE

NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE

NITROGLYCERIN, NITROGLYCERIN

NYSTATIN, NYSTATIN

OLANZAPINE, OLANZAPINE

OLMESARTAN MEDOXOMIL, OLMESARTAN MEDOXOMIL
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 217

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z **

* ZYDUS PHARMACEUTICALS USA INC

OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE

OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE

OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE

PEMETREXED DISODIUM, PEMETREXED DISODIUM

PERPHENAZINE, PERPHENAZINE

PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE

PITAVASTATIN CALCIUM, PITAVASTATIN CALCIUM

PLERIXAFOR, PLERIXAFOR

POTASSIUM CHLORIDE, POTASSIUM CHLORIDE

POTASSIUM CITRATE, POTASSIUM CITRATE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE

RAMELTEON, RAMELTEON

RIVASTIGMINE, RIVASTIGMINE

ROFLUMILAST, ROFLUMILAST

SEVELAMER CARBONATE, SEVELAMER CARBONATE

SIROLIMUS, SIROLIMUS

SPIRONOLACTONE, SPIRONOLACTONE

SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE

SUGAMMADEX SODIUM, SUGAMMADEX SODIUM

TADALAFIL, TADALAFIL

TAMOXIFEN CITRATE, TAMOXIFEN CITRATE

TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TELMISARTAN, TELMISARTAN

TEMOZOLOMIDE, TEMOZOLOMIDE

TERIFLUNOMIDE, TERIFLUNOMIDE

TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE

TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE

TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

TRIAZOLAM, TRIAZOLAM

TRIENTINE HYDROCHLORIDE, TRIENTINE HYDROCHLORIDE

VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE

VORICONAZOLE, VORICONAZOLE

ZINC SULFATE, ZINC SULFATE

ZOLMITRIPTAN, ZOLMITRIPTAN

ZYDUS PHARMS USA

* ZYDUS PHARMACEUTICALS USA INC

AMLODIPINE BESYLATE, AMLODIPINE BESYLATE

ATENOLOL, ATENOLOL

AZATHIOPRINE, AZATHIOPRINE

BENZONATATE, BENZONATATE

CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE

HALOPERIDOL, HALOPERIDOL

LAMOTRIGINE, LAMOTRIGINE

MELOXICAM, MELOXICAM

METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE

NAPROXEN, NAPROXEN

PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE

PRAVASTATIN SODIUM, PRAVASTATIN SODIUM

PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE

RAMIPRIL, RAMIPRIL

RIBAVIRIN, RIBAVIRIN

RISPERIDONE, RISPERIDONE

SIMVASTATIN, SIMVASTATIN

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

WARFARIN SODIUM, WARFARIN SODIUM

ZYDUS PHARMS USA INC

* ZYDUS PHARMACEUTICALS USA INC

AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE

ANASTROZOLE, ANASTROZOLE

ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE

BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
DECEMBER 2023 - APPROVED DRUG PRODUCT LIST B - 218

APPENDIX B - PRODUCT NAME SORTED BY APPLICANT

** Z **

* ZYDUS PHARMACEUTICALS USA INC

CARVEDILOL, CARVEDILOL

DIPYRIDAMOLE, DIPYRIDAMOLE

DIVALPROEX SODIUM, DIVALPROEX SODIUM

FINASTERIDE, FINASTERIDE

GABAPENTIN, GABAPENTIN

GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE

GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE

HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE

IRBESARTAN, IRBESARTAN

LAMOTRIGINE, LAMOTRIGINE

LEVETIRACETAM, LEVETIRACETAM

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE

LOSARTAN POTASSIUM, LOSARTAN POTASSIUM

OMEPRAZOLE, OMEPRAZOLE

PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE

PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE

RISPERIDONE, RISPERIDONE

TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE

TOPIRAMATE, TOPIRAMATE

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN

TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE

ZOLMITRIPTAN, ZOLMITRIPTAN

ZYLA

* ZYLA LIFE SCIENCES US INC

INDOCIN, INDOMETHACIN

SPRIX, KETOROLAC TROMETHAMINE