Pre-Hatch-Waxman Abbreviated New Drug Applications in the Orange Book

DESCRIPTION 

This is a list of products currently included in the Orange Book and identified as an “ANDA” in 

the Orange Book that were approved in a pre-Hatch-Waxman abbreviated new drug application (PANDA) 

for safety and effectiveness under section 505(c) of the Federal Food, Drug, and Cosmetic Act 

(FD&C Act) prior to the enactment of the Hatch-Waxman Amendments. This list includes only those 

PANDAs submitted under section 505(b) of the FD&C Act and does not include applications for 

antibiotic drug products approved under section 507 of the FD&C Act before the enactment of the 

Food and Drug Administration Modernization Act of 1997.

This list includes two sections: 1) products listed in the Prescription Drug Product List of the 

Orange Book; and 2) products listed in the Discontinued Drug Product List of the Orange Book. The 

list is presented in alphabetical order by the Established Name of the drug; the list also 

includes the Proprietary Name, Application Holder, Dosage Form, Route, Strength, Application 

Number, and Approval Date for each product. 

Current as of July 2021

Page 1 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE PHARM ASSOC SOLUTION; ORAL

120MG/5ML; 

12MG/5ML A087508 Aug 21, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SUN PHARM INDS LTD TABLET; ORAL 300MG; 30MG A085868 Nov 06, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SUN PHARM INDS LTD TABLET; ORAL 300MG; 60MG A087083 Jan 23, 1980

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE OXYCET SPECGX LLC TABLET; ORAL 325MG; 5MG A087463 Dec 07, 1983

ACETAZOLAMIDE ACETAZOLAMIDE LANNETT TABLET; ORAL 250MG A084840 Mar 31, 1978

ACETIC ACID, GLACIAL ACETIC ACID TARO

SOLUTION/DROPS; 

OTIC 2% A088638 Sep 06, 1984

AMINOPHYLLINE AMINOPHYLLINE HOSPIRA

INJECTABLE; 

INJECTION 25MG/ML A087242 Oct 26, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MYLAN TABLET; ORAL 100MG A086009 Apr 26, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MYLAN TABLET; ORAL 10MG A086009 Apr 26, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MYLAN TABLET; ORAL 25MG A086009 Apr 10, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MYLAN TABLET; ORAL 50MG A086009 Apr 10, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MYLAN TABLET; ORAL 75MG A086009 Apr 10, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MYLAN TABLET; ORAL 150MG A086009 Apr 26, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE SANDOZ TABLET; ORAL 50MG A085968 Nov 29, 1977

AMMONIUM CHLORIDE

AMMONIUM CHLORIDE IN PLASTIC 

CONTAINER HOSPIRA

INJECTABLE; 

INJECTION 5MEQ/ML A088366 Jun 13, 1984

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE ANI PHARMS TABLET; ORAL

0.025MG; 

2.5MG A086727 Oct 29, 1979

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE HIKMA SOLUTION; ORAL

0.025MG/5ML; 

2.5MG/5ML A087708 May 03, 1982

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE LANNETT TABLET; ORAL

0.025MG; 

2.5MG A085372 Feb 21, 1978

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE 

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

0.025MG; 

MYLAN TABLET; ORAL 2.5MG A085762 Nov 17, 1977

BETHANECHOL CHLORIDE DUVOID CHARTWELL RX TABLET; ORAL 50MG A085882 Mar 22, 1978

Current as of July 2021 Page 2 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

BETHANECHOL CHLORIDE DUVOID CHARTWELL RX TABLET; ORAL 10MG A086262 Mar 22, 1978

BETHANECHOL CHLORIDE DUVOID CHARTWELL RX TABLET; ORAL 25MG A086263 Mar 22, 1978

CAFFEINE; ERGOTAMINE 

TARTRATE CAFERGOT SANDOZ TABLET; ORAL 100MG; 1MG A084294 Sep 29, 1976

CAFFEINE; ERGOTAMINE 

TARTRATE MIGERGOT COSETTE

SUPPOSITORY; 

RECTAL 100MG; 2MG A086557 Oct 04, 1983

CARISOPRODOL CARISOPRODOL WATSON LABS TABLET; ORAL 350MG A087499 Apr 20, 1982

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE BARR CAPSULE; ORAL 10MG A083116 Jun 10, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE BARR CAPSULE; ORAL 5MG A084768 Jun 10, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE BARR CAPSULE; ORAL 25MG A084769 Jun 10, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LIBRIUM VALEANT PHARM INTL CAPSULE; ORAL 5MG A085461 Sep 21, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LIBRIUM VALEANT PHARM INTL CAPSULE; ORAL 10MG A085472 Sep 21, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LIBRIUM VALEANT PHARM INTL CAPSULE; ORAL 25MG A085475 Sep 21, 1977

CHLOROPROCAINE 

HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 3% A087446 Apr 16, 1982

CHLOROPROCAINE 

HYDROCHLORIDE CHLOROPROCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 2% A087447 Apr 16, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET; ORAL 10MG A083386 Jul 09, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET; ORAL 25MG A084112 Jul 09, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET; ORAL 50MG A084113 Jul 09, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET; ORAL 100MG A084114 Jul 09, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET; ORAL 200MG A084115 Jul 09, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 25MG/ML A083329 Jul 25, 1974

CHLORTHALIDONE CHLORTHALIDONE MYLAN TABLET; ORAL 25MG A086831 Feb 26, 1981

CHLORTHALIDONE CHLORTHALIDONE MYLAN TABLET; ORAL 50MG A086831 Feb 26, 1981

COLCHICINE; PROBENECID COL-PROBENECID WATSON LABS TABLET; ORAL 0.5MG; 500MG A084279 Nov 23, 1976

CORTISONE ACETATE CORTISONE ACETATE HIKMA INTL PHARMS TABLET; ORAL 25MG A080776 Nov 30, 1981

CROTAMITON CROTAN MARNEL PHARMS LOTION; TOPICAL 10% A087204 Dec 16, 1981

Current as of July 2021 Page 3 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CYANOCOBALAMIN CYANOCOBALAMIN AM REGENT

INJECTABLE; 

INJECTION 1MG/ML A080737 Apr 26, 1972

CYANOCOBALAMIN CYANOCOBALAMIN WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 1MG/ML A080515 Oct 20, 1971

CYANOCOBALAMIN VIBISONE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 1MG/ML A080557 Jun 20, 1973

CYCLOPENTOLATE 

HYDROCHLORIDE CYCLOGYL ALCON LABS INC

SOLUTION/DROPS; 

OPHTHALMIC 2% A084108 Jul 31, 1974

CYCLOPENTOLATE 

HYDROCHLORIDE CYCLOGYL ALCON LABS INC

SOLUTION/DROPS; 

OPHTHALMIC 0.5% A084109 Jul 31, 1974

CYCLOPENTOLATE 

HYDROCHLORIDE CYCLOGYL ALCON LABS INC

SOLUTION/DROPS; 

OPHTHALMIC 1% A084110 Jul 31, 1974

CYCLOPENTOLATE 

HYDROCHLORIDE; 

PHENYLEPHRINE HYDROCHLORIDE CYCLOMYDRIL ALCON LABS INC

SOLUTION/DROPS; 

OPHTHALMIC 0.2%; 1% A084300 Sep 12, 1975

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE HERITAGE PHARMA TABLET; ORAL 4MG A087056 Jan 10, 1980

DAPSONE DAPSONE JACOBUS TABLET; ORAL 25MG A086841 Jul 03, 1979

DAPSONE DAPSONE JACOBUS TABLET; ORAL 100MG A086842 Jul 03, 1979

DEXAMETHASONE DEXAMETHASONE ANIMA ELIXIR; ORAL 0.5MG/5ML A084754 Sep 21, 1976

DEXAMETHASONE DEXAMETHASONE FERA PHARMS LLC TABLET; ORAL 0.5MG A088481 Apr 28, 1983

DEXAMETHASONE DEXAMETHASONE FERA PHARMS LLC TABLET; ORAL 6MG A088481 Nov 28, 1983

DEXAMETHASONE DEXAMETHASONE FERA PHARMS LLC TABLET; ORAL 0.75MG A088481 Apr 28, 1983

DEXAMETHASONE DEXAMETHASONE FERA PHARMS LLC TABLET; ORAL 4MG A088481 Apr 28, 1983

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 1.5MG A084610 May 19, 1975

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 0.5MG A084611 Jul 25, 1975

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 4MG A084612 Jul 19, 1978

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 0.75MG A084613 Jun 03, 1975

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 2MG A087916 Aug 26, 1982

DEXAMETHASONE DEXAMETHASONE HIKMA SOLUTION; ORAL 0.5MG/5ML A088248 Sep 01, 1983

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 1MG A088306 Sep 15, 1983

DEXAMETHASONE DEXAMETHASONE HIKMA TABLET; ORAL 6MG A088316 Sep 15, 1983

DEXAMETHASONE DEXAMETHASONE WOCKHARDT BIO AG ELIXIR; ORAL 0.5MG/5ML A088254 Jul 27, 1983

DEXAMETHASONE DEXAMETHASONE XSPIRE PHARMA TABLET; ORAL 1.5MG A088237 Apr 28, 1983

DEXAMETHASONE DEXAMETHASONE INTENSOL HIKMA

CONCENTRATE; 

ORAL 1MG/ML A088252 Sep 01, 1983

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE FRESENIUS KABI USA

INJECTABLE; 

INJECTION

EQ 4MG 

PHOSPHATE/ML A084916 Sep 06, 1977

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION

EQ 4MG 

PHOSPHATE/ML A084282 Jul 15, 1975

Current as of July 2021 Page 4 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION

EQ 10MG 

PHOSPHATE/ML A087702 Sep 07, 1982

DEXCHLORPHENIRAMINE MALEATE DEXCHLORPHENIRAMINE MALEATE WOCKHARDT BIO AG SYRUP; ORAL 2MG/5ML A088251 Mar 23, 1984

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM MD-GASTROVIEW LIEBEL-FLARSHEIM

SOLUTION; ORAL, 

RECTAL 66%; 10% A087388 Sep 02, 1981

DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE LANNETT CAPSULE; ORAL 10MG A084285 Sep 30, 1974

DIGOXIN DIGOXIN WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 0.25MG/ML A083391 Oct 24, 1975

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PHARM ASSOC ELIXIR; ORAL 12.5MG/5ML A087513 Feb 10, 1982

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 50MG/ML A080817 Nov 27, 1972

DISULFIRAM ANTABUSE ODYSSEY PHARMS TABLET; ORAL 250MG A088482 Dec 08, 1983

DISULFIRAM ANTABUSE ODYSSEY PHARMS TABLET; ORAL 500MG A088483 Dec 08, 1983

ERGOCALCIFEROL VITAMIN D BIONPHARMA INC CAPSULE; ORAL 50,000 IU A080704 Oct 16, 1978

ERGOTAMINE TARTRATE ERGOMAR TERSERA

TABLET; 

SUBLINGUAL 2MG A087693 Feb 24, 1983

ESTRADIOL ESTRACE ALLERGAN CREAM; VAGINAL 0.01% A086069 Jan 31, 1984

ESTRADIOL CYPIONATE DEPO-ESTRADIOL PFIZER

INJECTABLE; 

INJECTION 5MG/ML A085470 Aug 15, 1979

ESTROGENS, ESTERIFIED MENEST MONARCH PHARMS TABLET; ORAL 0.625MG A084948 Sep 28, 1977

ESTROGENS, ESTERIFIED MENEST MONARCH PHARMS TABLET; ORAL 2.5MG A084949 Sep 28, 1977

ESTROGENS, ESTERIFIED MENEST MONARCH PHARMS TABLET; ORAL 1.25MG A084950 Sep 28, 1977

ESTROGENS, ESTERIFIED MENEST MONARCH PHARMS TABLET; ORAL 0.3MG A084951 Sep 28, 1977

ESTROPIPATE OGEN 5 PFIZER TABLET; ORAL 6MG A083220 May 19, 1977

ETHOSUXIMIDE ZARONTIN PARKE-DAVIS SYRUP; ORAL 250MG/5ML A080258 Feb 13, 1974

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FOUGERA PHARMS INC

SOLUTION; 

TOPICAL 0.01% A088167 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FOUGERA PHARMS INC

OINTMENT; 

TOPICAL 0.025% A088168 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FOUGERA PHARMS INC CREAM; TOPICAL 0.025% A088169 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE FOUGERA PHARMS INC CREAM; TOPICAL 0.01% A088170 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE TARO CREAM; TOPICAL 0.025% A087104 Apr 27, 1982

FOLIC ACID FOLIC ACID WATSON LABS TABLET; ORAL 1MG A080680 Dec 23, 1971

HEPARIN SODIUM HEPARIN SODIUM HOSPIRA

INJECTABLE; 

INJECTION 5,000 UNITS/ML A088100 Apr 28, 1983

HOMATROPINE METHYLBROMIDE; 

HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE AND 

HOMATROPINE METHYLBROMIDE ACTAVIS MID ATLANTIC SYRUP; ORAL

1.5MG/5ML; 

5MG/5ML A088017 Jul 05, 1983

Current as of July 2021 Page 5 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HOMATROPINE METHYLBROMIDE; 

HYDROCODONE BITARTRATE

HYDROCODONE BITARTRATE AND 

HOMATROPINE METHYLBROMIDE WOCKHARDT BIO AG SYRUP; ORAL

1.5MG/5ML; 

5MG/5ML A088008 Mar 03, 1983

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE HERITAGE PHARMS INC TABLET; ORAL 25MG A086242 Oct 23, 1978

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE HERITAGE PHARMS INC TABLET; ORAL 50MG A086242 Oct 23, 1978

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 25MG A086961 Feb 27, 1980

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 50MG A086962 Feb 27, 1980

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 10MG A087836 Oct 05, 1982

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 100MG A088391 Sep 27, 1983

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PLIVA TABLET; ORAL 25MG A088467 May 01, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PLIVA TABLET; ORAL 50MG A088468 May 01, 1984

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HERITAGE PHARMS INC TABLET; ORAL 25MG A085182 Jan 20, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HERITAGE PHARMS INC TABLET; ORAL 50MG A085182 Jan 20, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS TABLET; ORAL 25MG A083177 Jan 12, 1973

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS TABLET; ORAL 50MG A083177 Jan 12, 1973

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE OXFORD PHARMS TABLET; ORAL 25MG A087059 Nov 05, 1980

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE OXFORD PHARMS TABLET; ORAL 50MG A087068 Nov 05, 1980

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE AND 

HYDROCHLOROTHIAZIDE MYLAN TABLET; ORAL 25MG; 25MG A086513 Aug 03, 1979

HYDROCORTISONE ALA-CORT CROWN LABS CREAM; TOPICAL 1% A080706 Mar 09, 1973

HYDROCORTISONE ALA-SCALP MARNEL PHARMS LOTION; TOPICAL 2% A083231 Feb 28, 1973

HYDROCORTISONE ANUSOL HC SALIX PHARMS CREAM; TOPICAL 2.5% A088250 Jun 06, 1984

HYDROCORTISONE HYDROCORTISONE ACTAVIS MID ATLANTIC CREAM; TOPICAL 1% A087795 May 03, 1983

HYDROCORTISONE HYDROCORTISONE FOUGERA PHARMS

OINTMENT; 

TOPICAL 1% A080692 Apr 16, 1975

HYDROCORTISONE HYDROCORTISONE FOUGERA PHARMS INC CREAM; TOPICAL 1% A080693 May 01, 1973

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK CREAM; TOPICAL 2.5% A085025 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK

OINTMENT; 

TOPICAL 2.5% A085027 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE TARO

OINTMENT; 

TOPICAL 1% A086257 Jul 24, 1978

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE EPIFOAM MYLAN SPECIALITY LP

AEROSOL, 

METERED; 

TOPICAL 1%; 1% A086457 Dec 19, 1979

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE PRAMOSONE SEBELA IRELAND LTD CREAM; TOPICAL 0.5%; 1% A083778 Aug 13, 1976

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE PRAMOSONE SEBELA IRELAND LTD CREAM; TOPICAL 1%; 1% A085368 Jan 07, 1977

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE PRAMOSONE SEBELA IRELAND LTD LOTION; TOPICAL 2.5%; 1% A085979 Jun 05, 1978

Current as of July 2021 Page 6 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE PRAMOSONE SEBELA IRELAND LTD LOTION; TOPICAL 1%; 1% A085980 Jun 05, 1978

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE PROCTOFOAM HC MYLAN SPECIALITY LP

AEROSOL, 

METERED; 

TOPICAL 1%; 1% A086195 Jul 26, 1978

HYDROXOCOBALAMIN HYDROXOCOBALAMIN ACTAVIS LLC

INJECTABLE; 

INJECTION 1MG/ML A085998 Aug 16, 1978

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE AM REGENT

INJECTABLE; 

INJECTION 25MG/ML A087408 Aug 27, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE AM REGENT

INJECTABLE; 

INJECTION 50MG/ML A087408 Aug 27, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WOCKHARDT BIO AG SYRUP; ORAL 10MG/5ML A087294 Apr 12, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE BARR CAPSULE; ORAL

EQ 50MG 

HYDROCHLORIDE A088487 Jun 15, 1984

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE BARR CAPSULE; ORAL

EQ 100MG 

HYDROCHLORIDE A088488 Jun 15, 1984

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE BARR CAPSULE; ORAL

EQ 25MG 

HYDROCHLORIDE A088496 Jun 15, 1984

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE SANDOZ CAPSULE; ORAL

EQ 50MG 

HYDROCHLORIDE A086183 Dec 14, 1981

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE SANDOZ CAPSULE; ORAL

EQ 25MG 

HYDROCHLORIDE A087479 Dec 14, 1981

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 25MG A088262 Oct 21, 1983

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 50MG A088276 Oct 21, 1983

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE PAR PHARM TABLET; ORAL 10MG A088292 Oct 21, 1983

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SANDOZ TABLET; ORAL 25MG A083745 Apr 20, 1976

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SANDOZ TABLET; ORAL 10MG A084936 Mar 07, 1977

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SANDOZ TABLET; ORAL 50MG A084937 Apr 20, 1976

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SPECGX LLC TABLET; ORAL 10MG A087846 May 22, 1984

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SPECGX LLC TABLET; ORAL 25MG A087846 May 22, 1984

IMIPRAMINE HYDROCHLORIDE TOFRANIL SPECGX LLC TABLET; ORAL 50MG A087846 May 22, 1984

ISONIAZID ISONIAZID BARR TABLET; ORAL 100MG A080936 Aug 24, 1972

ISONIAZID ISONIAZID BARR TABLET; ORAL 300MG A080937 Oct 24, 1974

ISONIAZID ISONIAZID CMP PHARMA INC SYRUP; ORAL 50MG/5ML A088235 Nov 10, 1983

LIDOCAINE LIDOCAINE FOUGERA PHARMS INC

OINTMENT; 

TOPICAL 5% A080198 Jun 30, 1972

LIDOCAINE LIDOCAINE TARO

OINTMENT; 

TOPICAL 5% A086724 Aug 17, 1981

LIDOCAINE HYDROCHLORIDE LARYNG-O-JET KIT INTL MEDICATION

SOLUTION; 

TOPICAL 4% A086364 Mar 06, 1980

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 1% A080404 Dec 29, 1971

Current as of July 2021 Page 7 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 2% A080404 Dec 29, 1971

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 1% A083158 Oct 31, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 2% A083158 Oct 31, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 2% A088294 May 17, 1984

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 0.5% A088328 May 17, 1984

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 1% A088329 May 17, 1984

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INTL MEDICATION

INJECTABLE; 

INJECTION 1% A083173 Sep 17, 1975

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INTL MEDICATION

INJECTABLE; 

INJECTION 2% A083173 Sep 17, 1975

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE INTL MEDICATION JELLY; TOPICAL 2% A086283 Aug 07, 1979

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 1% A080407 Feb 14, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 2% A080407 Feb 14, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WOCKHARDT BIO AG SOLUTION; ORAL 2% A087872 Nov 18, 1982

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WOCKHARDT BIO AG

SOLUTION; 

TOPICAL 4% A087881 Nov 18, 1982

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 5% 

AND DEXTROSE 7.5% HOSPIRA

INJECTABLE; 

SPINAL 5% A083914 Jan 23, 1974

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE IN 

PLASTIC CONTAINER HOSPIRA

INJECTABLE; 

INJECTION 1% A088299 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE IN 

PLASTIC CONTAINER HOSPIRA

INJECTABLE; 

INJECTION 0.5% A088325 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE IN 

PLASTIC CONTAINER HOSPIRA

INJECTABLE; 

INJECTION 2% A088327 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

PRESERVATIVE FREE HOSPIRA

INJECTABLE; 

INJECTION 1% A080408 Sep 28, 1972

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

PRESERVATIVE FREE HOSPIRA

INJECTABLE; 

INJECTION 1.5% A080408 Sep 28, 1972

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

PRESERVATIVE FREE HOSPIRA

INJECTABLE; 

INJECTION 4% A088295 May 17, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

PRESERVATIVE FREE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 1% A084625 Jun 16, 1975

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

PRESERVATIVE FREE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 2% A084625 Jun 16, 1975

Current as of July 2021 Page 8 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE PRESCRIPTION DRUG PRODUCT LIST

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

LINDANE LINDANE WOCKHARDT BIO AG

SHAMPOO; 

TOPICAL 1% A088191 Sep 18, 1984

MANNITOL MANNITOL 25% FRESENIUS KABI USA

INJECTABLE; 

INJECTION 12.5GM/50ML A080677 Aug 11, 1972

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ANNORA PHARMA TABLET; ORAL 12.5MG A087128 Jun 03, 1981

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ANNORA PHARMA TABLET; ORAL 25MG A087128 Jun 03, 1981

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 100MG/ML A080445 Jan 22, 1975

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 25MG/ML A080445 Jan 22, 1975

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 50MG/ML A080445 Jan 22, 1975

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 75MG/ML A080445 Jan 22, 1975

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 100MG/ML A080455 Feb 13, 1974

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 25MG/ML A080455 Feb 13, 1974

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 50MG/ML A080455 Feb 13, 1974

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 75MG/ML A080455 Feb 13, 1974

METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE HIKMA SOLUTION; ORAL 5MG/5ML A087393 May 22, 1981

METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE HIKMA SOLUTION; ORAL 10MG/5ML A087997 Aug 30, 1982

METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE ROXANE TABLET; ORAL 5MG A088108 Mar 08, 1983

METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE ROXANE TABLET; ORAL 10MG A088109 Mar 08, 1983

METHOCARBAMOL METHOCARBAMOL PRINSTON INC TABLET; ORAL 750MG A086988 Oct 29, 1979

METHOCARBAMOL METHOCARBAMOL PRINSTON INC TABLET; ORAL 500MG A086989 Oct 29, 1979

METHYLTESTOSTERONE ANDROID 25 VALEANT PHARM INTL TABLET; ORAL 25MG A087147 Feb 09, 1981

METHYLTESTOSTERONE METHYLTESTOSTERONE IMPAX LABS TABLET; ORAL 10MG A080767 Oct 07, 1974

ORPHENADRINE CITRATE ORPHENADRINE CITRATE WATSON LABS

INJECTABLE; 

INJECTION 30MG/ML A084779 Mar 15, 1982

PENTOBARBITAL SODIUM NEMBUTAL SODIUM AKORN

INJECTABLE; 

INJECTION 50MG/ML A083246 Sep 19, 1973

PHENDIMETRAZINE TARTRATE BONTRIL PDM VALEANT TABLET; ORAL 35MG A085272 Dec 22, 1976

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VIRTUS PHARMS TABLET; ORAL 35MG A085588 Aug 19, 1977

PHENTERMINE HYDROCHLORIDE ADIPEX-P TEVA TABLET; ORAL 37.5MG A085128 Oct 22, 1980

PHENTERMINE HYDROCHLORIDE ADIPEX-P TEVA CAPSULE; ORAL 37.5MG A088023 Aug 02, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE LANNETT CAPSULE; ORAL 30MG A087022 Feb 03, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ CAPSULE; ORAL 30MG A086945 Jul 20, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ CAPSULE; ORAL 15MG A087190 Jun 12, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ CAPSULE; ORAL 30MG A087190 Jun 12, 1981

Current as of July 2021 Page 9 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PHENYTOIN DILANTIN PHARMACIA

TABLET, 

CHEWABLE; ORAL 50MG A084427 Feb 26, 1979

PHENYTOIN SODIUM DILANTIN UPJOHN CAPSULE; ORAL 100MG EXTENDED A084349 Aug 27, 1976

PHENYTOIN SODIUM DILANTIN UPJOHN CAPSULE; ORAL 30MG EXTENDED A084349 Aug 27, 1976

PHENYTOIN SODIUM PHENYTOIN SODIUM WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 50MG/ML A084307 Jul 16, 1975

PHYTONADIONE PHYTONADIONE INTL MEDICATION

INJECTABLE; 

INJECTION 1MG/0.5ML A083722 Mar 01, 1976

PHYTONADIONE VITAMIN K1 HOSPIRA

INJECTABLE; 

INJECTION 1MG/0.5ML A087954 Jul 25, 1983

PHYTONADIONE VITAMIN K1 HOSPIRA

INJECTABLE; 

INJECTION 10MG/ML A087955 Jul 25, 1983

POTASSIUM CHLORIDE POTASSIUM CHLORIDE B BRAUN

INJECTABLE; 

INJECTION 2MEQ/ML A085870 Mar 21, 1978

POTASSIUM CHLORIDE POTASSIUM CHLORIDE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 2MEQ/ML A080225 Jun 30, 1971

POTASSIUM CHLORIDE POTASSIUM CHLORIDE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 3MEQ/ML A080225 Jun 30, 1971

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE; 

INJECTION 2MEQ/ML A080205 Mar 16, 1972

PREDNISOLONE PREDNISOLONE WATSON LABS TABLET; ORAL 5MG A080354 Jan 17, 1972

PREDNISONE PREDNISONE HIKMA TABLET; ORAL 5MG A080352 Apr 21, 1972

PREDNISONE PREDNISONE HIKMA TABLET; ORAL 10MG A084122 May 17, 1974

PREDNISONE PREDNISONE HIKMA TABLET; ORAL 50MG A084283 Sep 09, 1977

PREDNISONE PREDNISONE HIKMA TABLET; ORAL 20MG A087342 May 15, 1981

PREDNISONE PREDNISONE HIKMA TABLET; ORAL 1MG A087800 Apr 22, 1982

PREDNISONE PREDNISONE HIKMA TABLET; ORAL 2.5MG A087801 Apr 22, 1982

PREDNISONE PREDNISONE MYLAN TABLET; ORAL 5MG A080292 May 22, 1972

PREDNISONE PREDNISONE MYLAN TABLET; ORAL 20MG A083677 Feb 26, 1974

PREDNISONE PREDNISONE WATSON LABS TABLET; ORAL 5MG A080356 Jan 17, 1972

PREDNISONE PREDNISONE WATSON LABS TABLET; ORAL 20MG A085161 Nov 11, 1976

PREDNISONE PREDNISONE WATSON LABS TABLET; ORAL 10MG A085162 Nov 12, 1976

PRIMIDONE PRIMIDONE LANNETT TABLET; ORAL 250MG A084903 Dec 01, 1978

PRIMIDONE PRIMIDONE WATSON LABS TABLET; ORAL 250MG A083551 Feb 07, 1979

PROBENECID PROBALAN LANNETT TABLET; ORAL 500MG A080966 Jul 29, 1976

PROBENECID PROBENECID MYLAN TABLET; ORAL 500MG A084211 Jan 13, 1976

PROBENECID PROBENECID WATSON LABS TEVA TABLET; ORAL 500MG A084442 Mar 29, 1983

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE INTL MEDICATION

INJECTABLE; 

INJECTION 100MG/ML A088636 Jul 31, 1984

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SANDOZ TABLET; ORAL 25MG A084176 Dec 19, 1975

Current as of July 2021 Page 10 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SANDOZ TABLET; ORAL 50MG A084176 Feb 18, 1975

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET; ORAL 25MG A083426 Sep 19, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET; ORAL 50MG A083711 Sep 21, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 25MG/ML A083312 Sep 19, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 50MG/ML A083312 Sep 19, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE PLAIN WOCKHARDT BIO AG SYRUP; ORAL 6.25MG/5ML A087953 Nov 15, 1982

PROPARACAINE HYDROCHLORIDE ALCAINE ALCON LABS INC

SOLUTION/DROPS; 

OPHTHALMIC 0.5% A080027 Dec 22, 1971

PROPYLTHIOURACIL PROPYLTHIOURACIL ACTAVIS ELIZABETH TABLET; ORAL 50MG A080172 Jan 09, 1973

PROPYLTHIOURACIL PROPYLTHIOURACIL QUAGEN TABLET; ORAL 50MG A080154 Jul 23, 1971

PYRAZINAMIDE PYRAZINAMIDE NOVITIUM PHARMA TABLET; ORAL 500MG A080157 Jun 03, 1971

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 100MG/ML A080618 Aug 14, 1972

QUINIDINE SULFATE QUINIDINE SULFATE SANDOZ TABLET; ORAL 200MG A088072 Nov 24, 1976

QUINIDINE SULFATE QUINIDINE SULFATE SANDOZ TABLET; ORAL 300MG A088072 Sep 26, 1983

SELENIUM SULFIDE SELENIUM SULFIDE WOCKHARDT BIO AG

LOTION/SHAMPOO; 

TOPICAL 2.5% A088228 Sep 01, 1983

SODIUM POLYSTYRENE 

SULFONATE SPS CMP PHARMA INC

SUSPENSION; 

ORAL, RECTAL 15GM/60ML A087859 Dec 08, 1982

STERILE WATER FOR INJECTION

STERILE WATER FOR INJECTION 

IN PLASTIC CONTAINER FRESENIUS KABI USA LIQUID; N/A 100% A088400 Jan 16, 1984

SULFACETAMIDE SODIUM BLEPH-10 ALLERGAN

SOLUTION/DROPS; 

OPHTHALMIC 10% A080028 May 25, 1971

SULFACETAMIDE SODIUM SULFACETAMIDE SODIUM PERRIGO CO TENNESSEE

OINTMENT; 

OPHTHALMIC 10% A080029 Dec 22, 1971

SULFASALAZINE SULFASALAZINE WATSON LABS TABLET; ORAL 500MG A085828 Oct 21, 1977

TESTOSTERONE TESTOPEL AUXILIUM PHARMS INC

PELLET; 

IMPLANTATION 75MG A080911 Jul 13, 1972

TESTOSTERONE CYPIONATE DEPO-TESTOSTERONE PFIZER

INJECTABLE; 

INJECTION 100MG/ML A085635 Jul 25, 1979

TESTOSTERONE CYPIONATE DEPO-TESTOSTERONE PFIZER

INJECTABLE; 

INJECTION 200MG/ML A085635 Jul 25, 1979

TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE WATSON PHARMS INC

INJECTABLE; 

INJECTION 200MG/ML A086030 Jul 30, 1981

Current as of July 2021 Page 11 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE WATSON PHARMS INC

INJECTABLE; 

INJECTION 200MG/ML A085598 Dec 10, 1980

TETRAHYDROZOLINE 

HYDROCHLORIDE TYZINE FOUGERA PHARMS SOLUTION; NASAL 0.05% A086576 Nov 30, 1979

TETRAHYDROZOLINE 

HYDROCHLORIDE TYZINE FOUGERA PHARMS SOLUTION; NASAL 0.1% A086576 Nov 30, 1979

TETRAHYDROZOLINE 

HYDROCHLORIDE TYZINE FOUGERA PHARMS SPRAY; NASAL 0.1% A086576 Nov 30, 1979

THEOPHYLLINE ELIXOPHYLLIN NOSTRUM LABS INC

SOLUTION, 

ELIXIR; ORAL 80MG/15ML A085186 Jan 26, 1979

THEOPHYLLINE THEO-24 ACTIENT PHARMS

CAPSULE, 

EXTENDED 

RELEASE; ORAL 100MG A087942 Aug 22, 1983

THEOPHYLLINE THEO-24 AUXILIUM PHARMS LLC

CAPSULE, 

EXTENDED 

RELEASE; ORAL 200MG A087943 Aug 22, 1983

THEOPHYLLINE THEO-24 AUXILIUM PHARMS LLC

CAPSULE, 

EXTENDED 

RELEASE; ORAL 300MG A087944 Aug 22, 1983

THEOPHYLLINE THEOPHYLLINE RHODES PHARMS

TABLET, 

EXTENDED 

RELEASE; ORAL 400MG A040086 Sep 01, 1982

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE; 

INJECTION 100MG/ML A080556 Jun 20, 1972

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE WEST-WARD PHARMS INT

INJECTABLE; 

INJECTION 100MG/ML A080575 Jun 24, 1975

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET; ORAL 100MG A088004 Nov 18, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET; ORAL 10MG A088004 Mar 15, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET; ORAL 25MG A088004 Mar 15, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET; ORAL 50MG A088004 Mar 15, 1983

TOLBUTAMIDE TOLBUTAMIDE MYLAN PHARMS INC TABLET; ORAL 500MG A086445 Apr 10, 1979

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE FOUGERA PHARMS

OINTMENT; 

TOPICAL 0.025% A085691 Mar 09, 1978

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE FOUGERA PHARMS

OINTMENT; 

TOPICAL 0.1% A085691 Mar 09, 1978

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE FOUGERA PHARMS

OINTMENT; 

TOPICAL 0.5% A085691 Mar 09, 1978

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE FOUGERA PHARMS CREAM; TOPICAL 0.025% A085692 Mar 09, 1978

Current as of July 2021 Page 12 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE FOUGERA PHARMS CREAM; TOPICAL 0.1% A085692 Mar 09, 1978

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE FOUGERA PHARMS CREAM; TOPICAL 0.5% A085692 Mar 09, 1978

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PERRIGO NEW YORK CREAM; TOPICAL 0.5% A086413 Apr 09, 1981

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PERRIGO NEW YORK

OINTMENT; 

TOPICAL 0.5% A087385 Nov 05, 1981

TRIAMCINOLONE ACETONIDE TRIDERM CROWN LABS CREAM; TOPICAL 0.1% A088042 Mar 19, 1984

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE SANDOZ TABLET; ORAL EQ 1MG BASE A085785 Nov 20, 1981

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE SANDOZ TABLET; ORAL EQ 2MG BASE A085786 Nov 20, 1981

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE SANDOZ TABLET; ORAL EQ 10MG BASE A085788 Nov 20, 1981

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE SANDOZ TABLET; ORAL EQ 5MG BASE A085789 Nov 20, 1981

TRIHEXYPHENIDYL 

HYDROCHLORIDE

TRIHEXYPHENIDYL 

HYDROCHLORIDE WATSON LABS TABLET; ORAL 2MG A084363 Nov 26, 1974

TRIHEXYPHENIDYL 

HYDROCHLORIDE

TRIHEXYPHENIDYL 

HYDROCHLORIDE WATSON LABS TABLET; ORAL 5MG A084364 Dec 06, 1974

TROPICAMIDE MYDRIACYL ALCON LABS INC

SOLUTION/DROPS; 

OPHTHALMIC 1% A084306 Dec 06, 1974

TROPICAMIDE MYDRIACYL SANDOZ INC

SOLUTION/DROPS; 

OPHTHALMIC 0.5% A084305 Dec 06, 1974

Current as of July 2021 Page 13 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ACETAMINOPHEN; ASPIRIN; 

CODEINE PHOSPHATE

CODEINE, ASPIRIN, APAP 

FORMULA NO. 2 SCHERER LABS CAPSULE;ORAL

150MG;180MG;15

MG A085640 May 10, 1978

ACETAMINOPHEN; ASPIRIN; 

CODEINE PHOSPHATE

CODEINE, ASPIRIN, APAP 

FORMULA NO. 3 SCHERER LABS CAPSULE;ORAL

150MG;180MG;30

MG A085639 May 10, 1978

ACETAMINOPHEN; ASPIRIN; 

CODEINE PHOSPHATE

CODEINE, ASPIRIN, APAP 

FORMULA NO. 4 SCHERER LABS CAPSULE;ORAL

150MG;180MG;60

MG A085638 May 10, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE ACI HEALTHCARE LTD SOLUTION;ORAL

120MG/5ML;12MG

/5ML A086366 Mar 27, 1979

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE ACTAVIS MID ATLANTIC SOLUTION;ORAL

120MG/5ML;12MG

/5ML A085861 Jun 20, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE DURAMED PHARMS BARR TABLET;ORAL 300MG;15MG A088353 Feb 06, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE DURAMED PHARMS BARR TABLET;ORAL 300MG;30MG A088354 Feb 06, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE DURAMED PHARMS BARR TABLET;ORAL 300MG;60MG A088355 Feb 06, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE EVERYLIFE TABLET;ORAL 325MG;30MG A085217 Mar 17, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE HALSEY TABLET;ORAL 300MG;15MG A083871 Oct 23, 1975

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE HALSEY TABLET;ORAL 300MG;30MG A083872 Oct 23, 1975

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE HALSEY TABLET;ORAL 300MG;60MG A086549 Jun 06, 1979

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE KV PHARM TABLET;ORAL 325MG;15MG A085364 Aug 23, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE KV PHARM TABLET;ORAL 325MG;45MG A085363 Aug 23, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE KV PHARM TABLET;ORAL 300MG;30MG A085288 Aug 23, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE KV PHARM TABLET;ORAL 300MG;60MG A085365 Aug 23, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE LEDERLE TABLET;ORAL 300MG;30MG A087141 Jun 12, 1980

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE MUTUAL PHARM TABLET;ORAL 300MG;15MG A085795 Jan 20, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE MUTUAL PHARM TABLET;ORAL 300MG;30MG A085794 Jan 20, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE MUTUAL PHARM TABLET;ORAL 300MG;60MG A087653 Apr 13, 1982

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE PURACAP PHARM TABLET;ORAL 300MG;30MG A087762 Dec 10, 1982

Current as of July 2021 Page 14 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE PUREPAC PHARM TABLET;ORAL 300MG;30MG A086681 May 11, 1979

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE PUREPAC PHARM TABLET;ORAL 300MG;60MG A086683 May 11, 1979

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE ROXANE TABLET;ORAL 300MG;15MG A084659 May 10, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE ROXANE TABLET;ORAL 300MG;30MG A084656 May 10, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE ROXANE TABLET;ORAL 300MG;60MG A084667 May 10, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SANDOZ TABLET;ORAL 300MG;15MG A087433 Jul 22, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SANDOZ TABLET;ORAL 300MG;30MG A085291 Jan 11, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SANDOZ TABLET;ORAL 300MG;30MG A085917 Aug 12, 1980

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SANDOZ TABLET;ORAL 300MG;60MG A085964 Jul 18, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE SANDOZ TABLET;ORAL 300MG;60MG A087423 Jul 22, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE TEVA CAPSULE;ORAL 300MG;15MG A088537 Jun 04, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE TEVA CAPSULE;ORAL 300MG;30MG A088324 Dec 29, 1983

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE TEVA CAPSULE;ORAL 300MG;60MG A088599 Jun 01, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE USL PHARMA TABLET;ORAL 300MG;30MG A087919 Jun 22, 1982

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE USL PHARMA TABLET;ORAL 300MG;60MG A087920 Jun 22, 1982

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE VALEANT PHARM INTL TABLET;ORAL 300MG;30MG A085896 Apr 26, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE VITARINE TABLET;ORAL 300MG;30MG A085676 Oct 27, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WARNER CHILCOTT TABLET;ORAL 300MG;15MG A085992 Mar 14, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WARNER CHILCOTT TABLET;ORAL 300MG;30MG A085218 Mar 14, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WARNER CHILCOTT TABLET;ORAL 300MG;60MG A087306 Feb 10, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WATSON LABS TABLET;ORAL 300MG;15MG A087277 May 26, 1982

Current as of July 2021 Page 15 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WATSON LABS TABLET;ORAL 300MG;30MG A087276 May 26, 1982

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WATSON LABS TABLET;ORAL 300MG;60MG A087275 May 26, 1982

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WHITEWORTH TOWN PLSN TABLET;ORAL 300MG;30MG A084360 Dec 19, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WHITEWORTH TOWN PLSN TABLET;ORAL 300MG;60MG A085607 Jul 05, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE

ACETAMINOPHEN AND CODEINE 

PHOSPHATE WOCKHARDT BIO AG SOLUTION;ORAL

120MG/5ML;12MG

/5ML A087006 Jul 22, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE CAPITAL AND CODEINE ACTAVIS MID ATLANTIC SUSPENSION;ORAL

120MG/5ML;12MG

/5ML A085883 Jan 08, 1979

ACETAMINOPHEN; CODEINE 

PHOSPHATE CAPITAL AND CODEINE CARNRICK TABLET;ORAL 325MG;30MG A083643 May 31, 1974

ACETAMINOPHEN; CODEINE 

PHOSPHATE CAPITAL AND CODEINE VALEANT PHARMS LLC SUSPENSION;ORAL

120MG/5ML;12MG

/5ML A086024 Jan 08, 1979

ACETAMINOPHEN; CODEINE 

PHOSPHATE

EMPRACET W/ CODEINE 

PHOSPHATE #3 GLAXOSMITHKLINE TABLET;ORAL 300MG;30MG A083951 Jan 06, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE

EMPRACET W/ CODEINE 

PHOSPHATE #4 GLAXOSMITHKLINE TABLET;ORAL 300MG;60MG A083951 Jan 06, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE PAPA-DEINE #3 VANGARD TABLET;ORAL 300MG;30MG A088037 Mar 20, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE PAPA-DEINE #4 VANGARD TABLET;ORAL 300MG;60MG A088715 Mar 20, 1984

ACETAMINOPHEN; CODEINE 

PHOSPHATE PHENAPHEN W/ CODEINE NO. 2 ROBINS AH CAPSULE;ORAL 325MG;15MG A084444 Jul 16, 1975

ACETAMINOPHEN; CODEINE 

PHOSPHATE PHENAPHEN W/ CODEINE NO. 3 ROBINS AH CAPSULE;ORAL 325MG;30MG A084445 Jul 22, 1975

ACETAMINOPHEN; CODEINE 

PHOSPHATE PHENAPHEN W/ CODEINE NO. 4 ROBINS AH CAPSULE;ORAL 325MG;60MG A084446 Jul 22, 1975

ACETAMINOPHEN; CODEINE 

PHOSPHATE PHENAPHEN-650 W/ CODEINE ROBINS AH TABLET;ORAL 650MG;30MG A085856 Feb 01, 1978

ACETAMINOPHEN; CODEINE 

PHOSPHATE PROVAL #3 SOLVAY CAPSULE;ORAL 325MG;30MG A085685 Nov 29, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE ORTHO MCNEIL PHARM SOLUTION;ORAL

120MG/5ML;12MG

/5ML A085057 Aug 17, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE ORTHO MCNEIL PHARM TABLET;ORAL 325MG;15MG A085056 Jul 09, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE ORTHO MCNEIL PHARM TABLET;ORAL 325MG;30MG A085056 Jul 09, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE ORTHO MCNEIL PHARM TABLET;ORAL 325MG;60MG A085056 Jul 09, 1976

Current as of July 2021 Page 16 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE ORTHO MCNEIL PHARM TABLET;ORAL 325MG;7.5MG A085056 Jul 09, 1976

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE NO. 1 JANSSEN PHARMS TABLET;ORAL 300MG;7.5MG A085055 Aug 17, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE NO. 2 JANSSEN PHARMS TABLET;ORAL 300MG;15MG A085055 Aug 01, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE NO. 3 JANSSEN PHARMS TABLET;ORAL 300MG;30MG A085055 Aug 01, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE NO. 3 ORTHO MCNEIL PHARM CAPSULE;ORAL 300MG;30MG A087422 Sep 29, 1981

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE NO. 4 JANSSEN PHARMS TABLET;ORAL 300MG;60MG A085055 Aug 01, 1977

ACETAMINOPHEN; CODEINE 

PHOSPHATE TYLENOL W/ CODEINE NO. 4 ORTHO MCNEIL PHARM CAPSULE;ORAL 300MG;60MG A087421 Sep 29, 1981

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE BANCAP HC FOREST PHARMS CAPSULE;ORAL 500MG;5MG A087961 Mar 17, 1983

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE CO-GESIC UCB INC TABLET;ORAL 500MG;5MG A087757 May 03, 1982

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE DURADYNE DHC FOREST PHARMS TABLET;ORAL 500MG;5MG A087809 Mar 17, 1983

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE HY-PHEN ASCHER TABLET;ORAL 500MG;5MG A087677 May 03, 1982

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE LORCET-HD MALLINCKRODT CAPSULE;ORAL 500MG;5MG A087336 Jul 08, 1982

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE LORTAB UCB INC TABLET;ORAL 500MG;5MG A087722 Jul 09, 1982

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE VICODIN ABBOTT TABLET;ORAL 500MG;5MG A085667 Dec 15, 1977

ACETAMINOPHEN; HYDROCODONE 

BITARTRATE VICODIN ABBVIE TABLET;ORAL 500MG;5MG A088058 Jan 07, 1983

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE OXYCODONE 2.5/APAP 500 BRISTOL MYERS SQUIBB TABLET;ORAL 500MG;2.5MG A085910 Oct 25, 1977

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE OXYCODONE 5/APAP 500 BRISTOL MYERS SQUIBB TABLET;ORAL 500MG;5MG A085911 Oct 25, 1977

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE OXYCODONE AND ACETAMINOPHEN BARR TABLET;ORAL 325MG;5MG A087406 Nov 02, 1981

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE PERCOCET VINTAGE PHARMS LLC TABLET;ORAL 325MG;5MG A085106 Feb 06, 1981

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE ROXICET HIKMA TABLET;ORAL 325MG;5MG A087003 Feb 25, 1980

Current as of July 2021 Page 17 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ACETAMINOPHEN; OXYCODONE 

HYDROCHLORIDE; OXYCODONE 

TEREPHTHALATE TYLOX ORTHO MCNEIL PHARM CAPSULE;ORAL

500MG;4.5MG;0.

38MG A085375 Jun 02, 1977

ACETAMINOPHEN; PROPOXYPHENE 

HYDROCHLORIDE DOLENE AP-65 LEDERLE TABLET;ORAL 650MG;65MG A085100 Sep 13, 1976

ACETAMINOPHEN; PROPOXYPHENE 

HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE 

AND ACETAMINOPHEN MYLAN TABLET;ORAL 650MG;65MG A083978 Oct 25, 1974

ACETAMINOPHEN; PROPOXYPHENE 

HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE 

AND ACETAMINOPHEN MYLAN TABLET;ORAL 325MG;32MG A083689 Oct 25, 1974

ACETAMINOPHEN; PROPOXYPHENE 

HYDROCHLORIDE WYGESIC CARACO TABLET;ORAL 650MG;65MG A084999 Sep 03, 1976

ACETAZOLAMIDE ACETAZOLAMIDE ALRA TABLET;ORAL 250MG A083320 Jul 18, 1974

ACETAZOLAMIDE ACETAZOLAMIDE ASCOT TABLET;ORAL 250MG A087686 Oct 20, 1982

ACETAZOLAMIDE ACETAZOLAMIDE VANGARD TABLET;ORAL 250MG A087654 Feb 05, 1982

ACETAZOLAMIDE ACETAZOLAMIDE WATSON LABS TABLET;ORAL 250MG A084498 Sep 12, 1977

ACETIC ACID, GLACIAL ACETASOL ACTAVIS MID ATLANTIC

SOLUTION/DROPS;

OTIC 2% A087146 Aug 12, 1981

ACETIC ACID, GLACIAL ACETIC ACID KV PHARM

SOLUTION/DROPS;

OTIC 2% A085493 May 11, 1977

ACETIC ACID, GLACIAL ORLEX WARNER CHILCOTT

SOLUTION/DROPS;

OTIC 2% A086845 Oct 26, 1979

ACETIC ACID, GLACIAL; 

ALUMINUM ACETATE DOMEBORO BAYER PHARMS

SOLUTION/DROPS;

OTIC 2%;0.79% A084476 Apr 30, 1976

ACETIC ACID, GLACIAL; 

HYDROCORTISONE ACETASOL HC ACTAVIS MID ATLANTIC

SOLUTION/DROPS;

OTIC 2%;1% A087143 Jan 13, 1982

ACETIC ACID, GLACIAL; 

HYDROCORTISONE

ACETIC ACID W/ 

HYDROCORTISONE KV PHARM

SOLUTION/DROPS;

OTIC 2%;1% A085492 May 10, 1977

ACETIC ACID, GLACIAL; 

HYDROCORTISONE ORLEX HC WARNER CHILCOTT

SOLUTION/DROPS;

OTIC 2%;1% A086844 Mar 03, 1980

ALCOHOL ALCOHOL 5% IN DEXTROSE 5% MILES

INJECTABLE;INJE

CTION 5ML/100ML A083483 Nov 22, 1974

ALCOHOL; DEXTROSE ALCOHOL 5% IN D5-W HOSPIRA

INJECTABLE;INJE

CTION

5ML/100ML;5GM/

100ML A083263 Feb 26, 1974

ALCOHOL; DEXTROSE

ALCOHOL 5% IN DEXTROSE 5% IN 

WATER BAXTER HLTHCARE

INJECTABLE;INJE

CTION

5ML/100ML;5GM/

100ML A083256 Mar 12, 1976

AMINOPHYLLINE AMINOPHYLLIN GD SEARLE LLC

INJECTABLE;INJE

CTION 25MG/ML A087243 May 24, 1982

Current as of July 2021 Page 18 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMINOPHYLLINE AMINOPHYLLIN GD SEARLE LLC

INJECTABLE;INJE

CTION 25MG/ML A087621 May 24, 1982

AMINOPHYLLINE AMINOPHYLLINE ABRAXIS PHARM

INJECTABLE;INJE

CTION 25MG/ML A088407 Jan 25, 1984

AMINOPHYLLINE AMINOPHYLLINE ABRAXIS PHARM

INJECTABLE;INJE

CTION 25MG/ML A087250 Jan 06, 1982

AMINOPHYLLINE AMINOPHYLLINE ABRAXIS PHARM

INJECTABLE;INJE

CTION 25MG/ML A084568 Nov 20, 1975

AMINOPHYLLINE AMINOPHYLLINE ABRAXIS PHARM

INJECTABLE;INJE

CTION 25MG/ML A087200 Aug 11, 1981

AMINOPHYLLINE AMINOPHYLLINE ABRAXIS PHARM

INJECTABLE;INJE

CTION 25MG/ML A087886 Aug 30, 1983

AMINOPHYLLINE AMINOPHYLLINE AM REGENT

INJECTABLE;INJE

CTION 25MG/ML A087600 Aug 27, 1981

AMINOPHYLLINE AMINOPHYLLINE ANI PHARMS TABLET;ORAL 200MG A085261 Dec 21, 1981

AMINOPHYLLINE AMINOPHYLLINE ASCOT TABLET;ORAL 100MG A087522 Feb 12, 1982

AMINOPHYLLINE AMINOPHYLLINE ASCOT TABLET;ORAL 200MG A087523 Feb 12, 1982

AMINOPHYLLINE AMINOPHYLLINE BARR TABLET;ORAL 100MG A088297 Aug 19, 1983

AMINOPHYLLINE AMINOPHYLLINE BARR TABLET;ORAL 200MG A088298 Aug 19, 1983

AMINOPHYLLINE AMINOPHYLLINE DURAMED PHARMS BARR TABLET;ORAL 100MG A088182 Mar 31, 1983

AMINOPHYLLINE AMINOPHYLLINE DURAMED PHARMS BARR TABLET;ORAL 200MG A088183 Mar 31, 1983

AMINOPHYLLINE AMINOPHYLLINE ELKINS SINN

INJECTABLE;INJE

CTION 25MG/ML A087239 Feb 11, 1981

AMINOPHYLLINE AMINOPHYLLINE HALSEY TABLET;ORAL 100MG A084674 Jun 15, 1976

AMINOPHYLLINE AMINOPHYLLINE HIKMA INTL PHARMS TABLET;ORAL 100MG A084540 Nov 26, 1975

AMINOPHYLLINE AMINOPHYLLINE HIKMA INTL PHARMS TABLET;ORAL 200MG A085003 May 28, 1976

AMINOPHYLLINE AMINOPHYLLINE HOSPIRA

INJECTABLE;INJE

CTION 25MG/ML A087601 Jul 23, 1982

AMINOPHYLLINE AMINOPHYLLINE IMPAX LABS

TABLET, DELAYED 

RELEASE;ORAL 100MG A084577 Mar 16, 1976

AMINOPHYLLINE AMINOPHYLLINE IMPAX LABS

TABLET, DELAYED 

RELEASE;ORAL 200MG A084575 Mar 19, 1976

AMINOPHYLLINE AMINOPHYLLINE IMPAX LABS TABLET;ORAL 100MG A084574 Feb 16, 1976

AMINOPHYLLINE AMINOPHYLLINE IMPAX LABS TABLET;ORAL 200MG A084576 Mar 17, 1976

AMINOPHYLLINE AMINOPHYLLINE INTL MEDICATION

INJECTABLE;INJE

CTION 25MG/ML A087867 Nov 10, 1983

AMINOPHYLLINE AMINOPHYLLINE INTL MEDICATION

INJECTABLE;INJE

CTION 25MG/ML A087868 Nov 10, 1983

AMINOPHYLLINE AMINOPHYLLINE INTL MEDICATION

INJECTABLE;INJE

CTION 25MG/ML A087209 Feb 01, 1982

Current as of July 2021 Page 19 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMINOPHYLLINE AMINOPHYLLINE KING PHARMS

INJECTABLE;INJE

CTION 25MG/ML A086606 Aug 23, 1979

AMINOPHYLLINE AMINOPHYLLINE KV PHARM TABLET;ORAL 100MG A085284 Oct 27, 1976

AMINOPHYLLINE AMINOPHYLLINE KV PHARM TABLET;ORAL 200MG A085289 Oct 29, 1976

AMINOPHYLLINE AMINOPHYLLINE LANNETT TABLET;ORAL 100MG A084588 Dec 17, 1975

AMINOPHYLLINE AMINOPHYLLINE LANNETT TABLET;ORAL 200MG A084588 Dec 17, 1975

AMINOPHYLLINE AMINOPHYLLINE LUITPOLD

INJECTABLE;INJE

CTION 25MG/ML A087240 Apr 16, 1981

AMINOPHYLLINE AMINOPHYLLINE LYPHOMED

INJECTABLE;INJE

CTION 25MG/ML A087431 Nov 10, 1981

AMINOPHYLLINE AMINOPHYLLINE MORTON GROVE SOLUTION;ORAL 105MG/5ML A088156 Dec 05, 1983

AMINOPHYLLINE AMINOPHYLLINE PAL PAK TABLET;ORAL 100MG A084533 May 28, 1976

AMINOPHYLLINE AMINOPHYLLINE PANRAY TABLET;ORAL 100MG A084552 Oct 21, 1975

AMINOPHYLLINE AMINOPHYLLINE PANRAY TABLET;ORAL 200MG A084552 Oct 21, 1975

AMINOPHYLLINE AMINOPHYLLINE PHARMA SERVE NY

INJECTABLE;INJE

CTION 25MG/ML A087392 Dec 15, 1983

AMINOPHYLLINE AMINOPHYLLINE PHARMA SERVE NY

INJECTABLE;INJE

CTION 25MG/ML A087387 Jun 03, 1983

AMINOPHYLLINE AMINOPHYLLINE PUREPAC PHARM TABLET;ORAL 100MG A084699 Dec 19, 1978

AMINOPHYLLINE AMINOPHYLLINE PUREPAC PHARM TABLET;ORAL 200MG A085333 Dec 19, 1978

AMINOPHYLLINE AMINOPHYLLINE ROXANE SOLUTION;ORAL 105MG/5ML A088126 Aug 19, 1983

AMINOPHYLLINE AMINOPHYLLINE ROXANE TABLET;ORAL 100MG A087500 Feb 09, 1982

AMINOPHYLLINE AMINOPHYLLINE ROXANE TABLET;ORAL 200MG A087501 Feb 09, 1982

AMINOPHYLLINE AMINOPHYLLINE TABLICAPS

TABLET, DELAYED 

RELEASE;ORAL 100MG A084632 Nov 26, 1976

AMINOPHYLLINE AMINOPHYLLINE VALE

TABLET, DELAYED 

RELEASE;ORAL 100MG A084531 May 26, 1976

AMINOPHYLLINE AMINOPHYLLINE VALE

TABLET, DELAYED 

RELEASE;ORAL 200MG A084530 Feb 04, 1976

AMINOPHYLLINE AMINOPHYLLINE VALEANT PHARM INTL TABLET;ORAL 200MG A084563 May 28, 1976

AMINOPHYLLINE AMINOPHYLLINE VANGARD TABLET;ORAL 100MG A088314 Oct 03, 1983

AMINOPHYLLINE AMINOPHYLLINE VANGARD TABLET;ORAL 200MG A088319 Oct 03, 1983

AMINOPHYLLINE AMINOPHYLLINE VINTAGE PHARMS TABLET;ORAL 100MG A085409 Feb 16, 1979

AMINOPHYLLINE AMINOPHYLLINE VINTAGE PHARMS TABLET;ORAL 200MG A085410 Feb 16, 1979

AMINOPHYLLINE AMINOPHYLLINE WATSON LABS TABLET;ORAL 100MG A085567 May 05, 1978

AMINOPHYLLINE AMINOPHYLLINE WATSON LABS TABLET;ORAL 200MG A085564 May 09, 1978

AMINOPHYLLINE AMINOPHYLLINE DYE FREE ACTAVIS MID ATLANTIC SOLUTION;ORAL 105MG/5ML A087727 Apr 16, 1982

AMINOPHYLLINE

AMINOPHYLLINE IN SODIUM 

CHLORIDE 0.45% HOSPIRA

INJECTABLE;INJE

CTION 100MG/100ML A088147 May 03, 1983

Current as of July 2021 Page 20 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMINOPHYLLINE

AMINOPHYLLINE IN SODIUM 

CHLORIDE 0.45% HOSPIRA

INJECTABLE;INJE

CTION 200MG/100ML A088147 May 03, 1983

AMINOPHYLLINE PHYLLOCONTIN PHARM RES ASSOC

TABLET, 

EXTENDED 

RELEASE;ORAL 225MG A086760 Nov 21, 1979

AMINOPHYLLINE SOMOPHYLLIN FISONS SOLUTION;ORAL 105MG/5ML A086466 Nov 15, 1978

AMINOPHYLLINE SOMOPHYLLIN-DF FISONS SOLUTION;ORAL 105MG/5ML A087045 Sep 30, 1980

AMINOPHYLLINE TRUPHYLLINE COSETTE

SUPPOSITORY;REC

TAL 250MG A085498 Mar 23, 1983

AMINOPHYLLINE TRUPHYLLINE COSETTE

SUPPOSITORY;REC

TAL 500MG A085498 Jan 03, 1983

AMINOSALICYLATE SODIUM P.A.S. SODIUM CENTURY PHARMS POWDER;ORAL 4GM/PACKET A080947 May 01, 1973

AMINOSALICYLATE SODIUM SODIUM AMINOSALICYLATE HEXCEL POWDER;ORAL 100% A080097 Apr 14, 1971

AMINOSALICYLATE SODIUM SODIUM P.A.S. LANNETT TABLET;ORAL 500MG A080138 Jan 17, 1978

AMINOSALICYLATE SODIUM; 

AMINOSALICYLIC ACID NEOPASALATE MEDPOINTE PHARM HLC TABLET;ORAL 846MG;112MG A080059 Aug 15, 1975

AMITRIPTYLINE HYDROCHLORIDE AMITID BRISTOL MYERS SQUIBB TABLET;ORAL 100MG A086454 Oct 19, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITID BRISTOL MYERS SQUIBB TABLET;ORAL 10MG A086454 Oct 19, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITID BRISTOL MYERS SQUIBB TABLET;ORAL 25MG A086454 Oct 19, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITID BRISTOL MYERS SQUIBB TABLET;ORAL 50MG A086454 Oct 19, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITID BRISTOL MYERS SQUIBB TABLET;ORAL 75MG A086454 Oct 19, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIL WARNER CHILCOTT TABLET;ORAL 100MG A085093 Apr 20, 1976

AMITRIPTYLINE HYDROCHLORIDE AMITRIL WARNER CHILCOTT TABLET;ORAL 10MG A083939 Apr 18, 1975

AMITRIPTYLINE HYDROCHLORIDE AMITRIL WARNER CHILCOTT TABLET;ORAL 25MG A083937 Apr 18, 1975

AMITRIPTYLINE HYDROCHLORIDE AMITRIL WARNER CHILCOTT TABLET;ORAL 50MG A083938 Oct 18, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIL WARNER CHILCOTT TABLET;ORAL 75MG A084957 Dec 31, 1975

AMITRIPTYLINE HYDROCHLORIDE AMITRIL WARNER CHILCOTT TABLET;ORAL 150MG A086295 Mar 09, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 10MG A085031 Nov 16, 1976

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 25MG A085031 Nov 16, 1976

Current as of July 2021 Page 21 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 50MG A085031 Nov 16, 1976

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 75MG A085031 Nov 16, 1976

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE COPLEY PHARM TABLET;ORAL 100MG A088425 Apr 30, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE COPLEY PHARM TABLET;ORAL 10MG A088421 Apr 30, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE COPLEY PHARM TABLET;ORAL 25MG A088422 Apr 30, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE COPLEY PHARM TABLET;ORAL 50MG A088423 Apr 30, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE COPLEY PHARM TABLET;ORAL 75MG A088424 Apr 30, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE COPLEY PHARM TABLET;ORAL 150MG A088426 Apr 30, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE HALSEY TABLET;ORAL 100MG A085927 May 20, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE HALSEY TABLET;ORAL 10MG A085923 May 24, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE HALSEY TABLET;ORAL 25MG A085922 May 15, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE HALSEY TABLET;ORAL 50MG A085925 Nov 18, 1981

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE HALSEY TABLET;ORAL 50MG A087557 Mar 05, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE HALSEY TABLET;ORAL 75MG A085926 May 20, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 100MG A086747 Feb 05, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 100MG A087368 May 03, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 10MG A087366 Jan 04, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 10MG A086744 Feb 05, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 25MG A086746 Feb 05, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 25MG A087367 May 03, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 50MG A087181 Jan 04, 1982

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 50MG A086743 Feb 05, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 75MG A087369 Jan 04, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 75MG A086745 Feb 05, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE LEDERLE TABLET;ORAL 150MG A087370 Jan 04, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 100MG A085742 May 11, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 10MG A085744 Jun 21, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 25MG A085627 May 10, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 50MG A085745 Jul 11, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 75MG A085743 Jul 11, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 100MG A088107 Jul 18, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 100MG A088079 Sep 16, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 10MG A088084 Jul 18, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 10MG A088075 Sep 16, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 25MG A088076 May 20, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 25MG A088085 Jul 18, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 50MG A088105 Jul 18, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 50MG A088077 Sep 16, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 75MG A088106 Jul 18, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 75MG A088078 Sep 16, 1983

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 100MG A086146 Jan 23, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 100MG A086003 Oct 03, 1977

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 10MG A086144 Jan 23, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 10MG A086002 Oct 03, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 25MG A086145 Jan 23, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 25MG A085944 Sep 29, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 50MG A086143 Jan 23, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 50MG A085945 Sep 29, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 75MG A086147 Jan 23, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 75MG A086004 Oct 03, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 150MG A086148 Jan 23, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE ROXANE TABLET;ORAL 150MG A086090 Oct 28, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 100MG A086854 Mar 13, 1980

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 100MG A085836 Aug 02, 1977

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 10MG A086610 Mar 13, 1980

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 25MG A086859 Mar 13, 1980

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 50MG A086857 Mar 13, 1980

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 75MG A086860 Mar 13, 1980

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE TEVA TABLET;ORAL 150MG A086853 Mar 13, 1980

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE UCB INC TABLET;ORAL 100MG A086336 Oct 02, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE UCB INC TABLET;ORAL 10MG A085864 Mar 13, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE UCB INC TABLET;ORAL 25MG A085935 Mar 13, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE UCB INC TABLET;ORAL 50MG A085936 Mar 13, 1978

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE UCB INC TABLET;ORAL 75MG A086337 Oct 02, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE UCB INC TABLET;ORAL 150MG A086335 Oct 02, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE USL PHARMA TABLET;ORAL 25MG A087775 Feb 10, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE VANGARD TABLET;ORAL 100MG A087639 Feb 08, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE VANGARD TABLET;ORAL 10MG A087632 Feb 01, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE VANGARD TABLET;ORAL 50MG A087616 Feb 08, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE VANGARD TABLET;ORAL 75MG A087617 Feb 05, 1982

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 10MG/ML A085594 May 24, 1979

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 100MG A088634 Mar 02, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 100MG A085820 Sep 01, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A088620 Mar 02, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A085816 Aug 15, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A088621 Mar 02, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A085817 Aug 15, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A088622 Mar 02, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085815 May 11, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 75MG A088633 Mar 02, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 75MG A085819 Aug 16, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 150MG A088635 Mar 02, 1984

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 150MG A085821 Sep 18, 1978

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WEST WARD TABLET;ORAL 10MG A087647 Mar 05, 1982

Current as of July 2021 Page 25 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE WEST WARD TABLET;ORAL 25MG A087278 Oct 07, 1981

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE

CONCENTRATE;ORA

L 40MG/ML A085749 Dec 23, 1977

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE TABLET;ORAL 100MG A083639 Mar 19, 1976

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE TABLET;ORAL 10MG A083639 May 12, 1975

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE TABLET;ORAL 25MG A083639 May 12, 1975

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE TABLET;ORAL 50MG A083639 May 12, 1975

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE TABLET;ORAL 75MG A083639 Jul 16, 1975

AMITRIPTYLINE HYDROCHLORIDE ENDEP ROCHE TABLET;ORAL 150MG A085303 Dec 27, 1976

AMMONIUM CHLORIDE AMMONIUM CHLORIDE ABBOTT

INJECTABLE;INJE

CTION 5MEQ/ML A083130 Nov 12, 1973

AMMONIUM CHLORIDE AMMONIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 3MEQ/ML A086205 Jan 30, 1979

AMMONIUM CHLORIDE AMMONIUM CHLORIDE 2.14% B BRAUN

INJECTABLE;INJE

CTION 40MEQ/100ML A085734 Oct 13, 1978

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA CAPSULE;ORAL

1.25MG;1.25MG;

1.25MG;1.25MG A083564 Oct 24, 1975

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA CAPSULE;ORAL

2.5MG;2.5MG;2.

5MG;2.5MG A083564 Oct 24, 1975

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA CAPSULE;ORAL

3.75MG;3.75MG;

3.75MG;3.75MG A083564 Oct 24, 1975

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA CAPSULE;ORAL

5MG;5MG;5MG;5M

G A083564 Oct 24, 1975

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA TABLET;ORAL

1.25MG;1.25MG;

1.25MG;1.25MG A083563 Oct 24, 1975

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA TABLET;ORAL

2.5MG;2.5MG;2.

5MG;2.5MG A083563 Oct 24, 1975

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA TABLET;ORAL

3.75MG;3.75MG;

3.75MG;3.75MG A083563 Oct 24, 1975

AMPHETAMINE ADIPATE; 

AMPHETAMINE SULFATE; 

DEXTROAMPHETAMINE ADIPATE; 

DEXTROAMPHETAMINE SULFATE DELCOBESE TEVA TABLET;ORAL

5MG;5MG;5MG;5M

G A083563 Oct 24, 1975

AMPHETAMINE SULFATE AMPHETAMINE SULFATE LANNETT TABLET;ORAL 10MG A083901 Aug 31, 1984

AMPHETAMINE SULFATE AMPHETAMINE SULFATE LANNETT TABLET;ORAL 5MG A083901 Aug 31, 1984

ANISOTROPINE METHYLBROMIDE ANISOTROPINE METHYLBROMIDE WATSON LABS TABLET;ORAL 50MG A086046 Jul 24, 1978

ASPIRIN; BUTALBITAL AXOTAL SAVAGE LABS TABLET;ORAL 650MG;50MG A088305 Oct 13, 1983

ASPIRIN; BUTALBITAL; 

CAFFEINE

BUTALBITAL, ASPIRIN AND 

CAFFEINE ACTAVIS ELIZABETH TABLET;ORAL

325MG;50MG;40M

G A086710 Aug 23, 1983

ASPIRIN; BUTALBITAL; 

CAFFEINE

BUTALBITAL, ASPIRIN AND 

CAFFEINE FOSUN PHARMA TABLET;ORAL

325MG;50MG;40M

G A086398 Apr 06, 1984

ASPIRIN; BUTALBITAL; 

CAFFEINE

BUTALBITAL, ASPIRIN AND 

CAFFEINE HIKMA INTL PHARMS TABLET;ORAL

325MG;50MG;40M

G A086162 Feb 16, 1984

ASPIRIN; BUTALBITAL; 

CAFFEINE

BUTALBITAL, ASPIRIN AND 

CAFFEINE PURACAP PHARM TABLET;ORAL

325MG;50MG;40M

G A087048 Dec 09, 1983

ASPIRIN; BUTALBITAL; 

CAFFEINE

BUTALBITAL, ASPIRIN AND 

CAFFEINE WATSON LABS TABLET;ORAL

325MG;50MG;40M

G A086237 Mar 23, 1984

ASPIRIN; CAFFEINE; 

PROPOXYPHENE HYDROCHLORIDE COMPOUND 65 ALRA CAPSULE;ORAL

389MG;32.4MG;6

5MG A084553 Aug 17, 1983

ASPIRIN; CAFFEINE; 

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE COMPOUND 65 SANDOZ CAPSULE;ORAL

389MG;32.4MG;6

5MG A080044 Sep 16, 1983

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ASPIRIN; CAFFEINE; 

PROPOXYPHENE HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE 

W/ ASPIRIN AND CAFFEINE WATSON LABS CAPSULE;ORAL

389MG;32.4MG;6

5MG A085732 Sep 03, 1984

ASPIRIN; HYDROCODONE 

BITARTRATE VICOPRIN ABBOTT TABLET;ORAL 500MG;5MG A086333 Sep 14, 1983

ASPIRIN; MEPROBAMATE MICRAININ MEDPOINTE PHARM HLC TABLET;ORAL 325MG;200MG A084978 Jul 31, 1978

ASPIRIN; MEPROBAMATE Q-GESIC QUANTUM PHARMICS TABLET;ORAL 325MG;200MG A088740 Jun 01, 1984

ASPIRIN; METHOCARBAMOL METHOCARBAMOL AND ASPIRIN IVAX SUB TEVA PHARMS TABLET;ORAL 325MG;400MG A087211 Dec 22, 1982

ASPIRIN; OXYCODONE 

HYDROCHLORIDE; OXYCODONE 

TEREPHTHALATE CODOXY HALSEY TABLET;ORAL

325MG;4.5MG;0.

38MG A087464 Jul 01, 1982

ASPIRIN; OXYCODONE 

HYDROCHLORIDE; OXYCODONE 

TEREPHTHALATE OXYCODONE AND ASPIRIN SUN PHARM INDUSTRIES TABLET;ORAL

325MG;4.5MG;0.

38MG A087794 May 26, 1982

ASPIRIN; OXYCODONE 

HYDROCHLORIDE; OXYCODONE 

TEREPHTHALATE

OXYCODONE AND ASPIRIN (HALFSTRENGTH) ROXANE TABLET;ORAL325MG;2.25MG;0

.19MG A087742 Jun 04, 1982

ASPIRIN; OXYCODONE 

HYDROCHLORIDE; OXYCODONE 

TEREPHTHALATE ROXIPRIN ROXANE TABLET;ORAL

325MG;4.5MG;0.

38MG A087743 Jun 04, 1982

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE COLONAID MEDPOINTE PHARM HLC SOLUTION;ORAL

0.025MG/5ML;2.

5MG/5ML A085735 Feb 13, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE COLONAID MEDPOINTE PHARM HLC TABLET;ORAL 0.025MG;2.5MG A085737 Jan 31, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE DI-ATRO MD PHARM TABLET;ORAL 0.025MG;2.5MG A085266 Apr 18, 1977

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE ASCOT TABLET;ORAL 0.025MG;2.5MG A087934 Jul 19, 1983

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE FOSUN PHARMA TABLET;ORAL 0.025MG;2.5MG A086173 Aug 28, 1981

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE HEATHER TABLET;ORAL 0.025MG;2.5MG A086798 Oct 03, 1979

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE HIKMA TABLET;ORAL 0.025MG;2.5MG A087765 Mar 15, 1982

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE INWOOD LABS TABLET;ORAL 0.025MG;2.5MG A085509 Mar 09, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE KV PHARM TABLET;ORAL 0.025MG;2.5MG A085659 Jan 27, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE LEDERLE TABLET;ORAL 0.025MG;2.5MG A086950 Jan 30, 1980

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE PARKE DAVIS TABLET;ORAL 0.025MG;2.5MG A087131 Jul 17, 1981

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE PVT FORM TABLET;ORAL 0.025MG;2.5MG A085766 Dec 22, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE R AND S PHARMA TABLET;ORAL 0.025MG;2.5MG A085035 Jul 05, 1977

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE ROXANE TABLET;ORAL 0.025MG;2.5MG A086057 Nov 21, 1977

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE SUN PHARM INDUSTRIES TABLET;ORAL 0.025MG;2.5MG A085506 Jun 03, 1977

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE USL PHARMA TABLET;ORAL 0.025MG;2.5MG A087842 Mar 29, 1982

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE VALEANT PHARM INTL TABLET;ORAL 0.025MG;2.5MG A087195 Feb 16, 1982

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

AND ATROPINE SULFATE WATSON LABS TABLET;ORAL 0.025MG;2.5MG A085876 Jun 22, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE

DIPHENOXYLATE HYDROCHLORIDE 

W/ ATROPINE SULFATE SCHERER RP CAPSULE;ORAL 0.025MG;2.5MG A086440 Apr 06, 1981

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE LOMANATE ALPHARMA US PHARMS SOLUTION;ORAL

0.025MG/5ML;2.

5MG/5ML A085746 Feb 23, 1978

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE LONOX FOSUN PHARMA TABLET;ORAL 0.025MG;2.5MG A085311 Oct 27, 1977

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE LO-TROL VANGARD TABLET;ORAL 0.025MG;2.5MG A088009 Mar 25, 1983

ATROPINE SULFATE; 

DIPHENOXYLATE HYDROCHLORIDE LOW-QUEL HALSEY TABLET;ORAL 0.025MG;2.5MG A085211 May 03, 1977

ATROPINE SULFATE; 

MEPERIDINE HYDROCHLORIDE ATROPINE AND DEMEROL ABBVIE

INJECTABLE;INJE

CTION

0.4MG/ML;100MG

/ML A087848 Nov 26, 1982

ATROPINE SULFATE; 

MEPERIDINE HYDROCHLORIDE ATROPINE AND DEMEROL ABBVIE

INJECTABLE;INJE

CTION

0.4MG/ML;50MG/

ML A087853 Nov 26, 1982

ATROPINE SULFATE; 

MEPERIDINE HYDROCHLORIDE ATROPINE AND DEMEROL ABBVIE

INJECTABLE;INJE

CTION

0.4MG/ML;75MG/

ML A087847 Nov 26, 1982

ATROPINE SULFATE; 

MEPERIDINE HYDROCHLORIDE

MEPERIDINE AND ATROPINE 

SULFATE WYETH AYERST

INJECTABLE;INJE

CTION

0.4MG/ML;100MG

/ML A085121 Aug 02, 1977

ATROPINE SULFATE; 

MEPERIDINE HYDROCHLORIDE

MEPERIDINE AND ATROPINE 

SULFATE WYETH AYERST

INJECTABLE;INJE

CTION

0.4MG/ML;50MG/

ML A085121 Aug 02, 1977

ATROPINE SULFATE; 

MEPERIDINE HYDROCHLORIDE

MEPERIDINE AND ATROPINE 

SULFATE WYETH AYERST

INJECTABLE;INJE

CTION

0.4MG/ML;75MG/

ML A085121 Aug 02, 1977

BENOXINATE HYDROCHLORIDE BENOXINATE HYDROCHLORIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 0.4% A084149 Jan 14, 1975

BENZTHIAZIDE BENZTHIAZIDE PVT FORM TABLET;ORAL 50MG A083206 Nov 19, 1976

BENZTROPINE MESYLATE BENZTROPINE MESYLATE QUANTUM PHARMICS TABLET;ORAL 0.5MG A088514 Jan 31, 1984

BENZTROPINE MESYLATE BENZTROPINE MESYLATE QUANTUM PHARMICS TABLET;ORAL 1MG A088510 Jan 31, 1984

BENZTROPINE MESYLATE BENZTROPINE MESYLATE QUANTUM PHARMICS TABLET;ORAL 2MG A088511 Jan 31, 1984

BENZYL BENZOATE BENZYL BENZOATE LANNETT

EMULSION;TOPICA

L 50% A084535 Sep 02, 1976

BETAMETHASONE SODIUM 

PHOSPHATE

BETAMETHASONE SODIUM 

PHOSPHATE WATSON LABS

INJECTABLE;INJE

CTION EQ 3MG BASE/ML A085738 Jan 30, 1979

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE ASCOT TABLET;ORAL 10MG A088288 Jun 08, 1983

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE ASCOT TABLET;ORAL 25MG A088289 Jun 08, 1983

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG A084689 Dec 16, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE LANNETT TABLET;ORAL 10MG A084712 Jul 29, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE LANNETT TABLET;ORAL 25MG A084074 Jul 01, 1976

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE LANNETT TABLET;ORAL 5MG A084702 Jun 16, 1976

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE SANDOZ TABLET;ORAL 10MG A084378 Sep 24, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE SANDOZ TABLET;ORAL 10MG A084379 Sep 24, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE SANDOZ TABLET;ORAL 25MG A084383 Sep 24, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE SANDOZ TABLET;ORAL 25MG A084384 Sep 24, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE SANDOZ TABLET;ORAL 5MG A084353 Feb 18, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 10MG A085228 Oct 14, 1976

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 10MG A084408 Nov 11, 1974

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 10MG A085842 Aug 26, 1977

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 25MG A084441 Jan 14, 1975

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 25MG A085839 Aug 26, 1977

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 25MG A085229 Sep 24, 1976

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 50MG A087397 Jul 16, 1981

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 50MG A087444 Jul 16, 1981

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 5MG A084402 Nov 26, 1974

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 5MG A085230 Feb 03, 1977

BETHANECHOL CHLORIDE BETHANECHOL CHLORIDE WATSON LABS TABLET;ORAL 5MG A085841 Aug 26, 1977

BETHANECHOL CHLORIDE MYOTONACHOL GLENWOOD TABLET;ORAL 10MG A084188 Sep 24, 1975

BETHANECHOL CHLORIDE MYOTONACHOL GLENWOOD TABLET;ORAL 25MG A084188 Sep 24, 1975

BETHANECHOL CHLORIDE MYOTONACHOL GLENWOOD TABLET;ORAL 5MG A084188 Sep 24, 1975

BETHANECHOL CHLORIDE URECHOLINE ODYSSEY PHARMS TABLET;ORAL 10MG A088440 May 29, 1984

BETHANECHOL CHLORIDE URECHOLINE ODYSSEY PHARMS TABLET;ORAL 25MG A088441 May 29, 1984

BROMODIPHENHYDRAMINE 

HYDROCHLORIDE; CODEINE 

PHOSPHATE BROMANYL ALPHARMA US PHARMS SYRUP;ORAL

12.5MG/5ML;10M

G/5ML A088343 Aug 15, 1984

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE ALPHARMA US PHARMS ELIXIR;ORAL 2MG/5ML A086936 Jul 16, 1981

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE BARR TABLET;ORAL 4MG A084468 Apr 07, 1975

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE IVAX SUB TEVA PHARMS TABLET;ORAL 4MG A084351 Dec 17, 1975

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE KV PHARM ELIXIR;ORAL 2MG/5ML A085466 Aug 19, 1977

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE NEWTRON PHARMS TABLET;ORAL 4MG A086987 Oct 26, 1979

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE NEXGEN PHARMA INC TABLET;ORAL 4MG A086187 Aug 24, 1978

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE PAR PHARM TABLET;ORAL 4MG A087009 May 28, 1981

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE PHARM ASSOC ELIXIR;ORAL 2MG/5ML A087517 Oct 09, 1981

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE PIONEER PHARMS TABLET;ORAL 4MG A088604 Jul 13, 1984

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE UPSHER SMITH LABS TABLET;ORAL 4MG A083215 Dec 19, 1975

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE USL PHARMA ELIXIR;ORAL 2MG/5ML A087964 Jan 25, 1983

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE VITARINE TABLET;ORAL 4MG A085850 Nov 06, 1978

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A083820 Feb 20, 1981

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE WATSON LABS

INJECTABLE;INJE

CTION 10MG/ML A083821 May 20, 1976

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE WATSON LABS TABLET;ORAL 4MG A083123 Nov 15, 1976

BROMPHENIRAMINE MALEATE BROMPHENIRAMINE MALEATE WATSON LABS TABLET;ORAL 4MG A085769 Aug 01, 1977

BUTABARBITAL SODIUM BUTABARB ALPHARMA US PHARMS ELIXIR;ORAL 30MG/5ML A085873 May 17, 1978

BUTABARBITAL SODIUM BUTABARBITAL BUNDY TABLET;ORAL 30MG A085550 May 31, 1978

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SANDOZ TABLET;ORAL 15MG A084292 Feb 09, 1982

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SANDOZ TABLET;ORAL 15MG A085938 Jul 17, 1978

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SANDOZ TABLET;ORAL 30MG A084272 Dec 22, 1981

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SANDOZ TABLET;ORAL 30MG A085934 Jul 17, 1978

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SOLVAY TABLET;ORAL 16.2MG A083606 Jun 14, 1974

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SOLVAY TABLET;ORAL 32.4MG A083898 Jun 21, 1974

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SOLVAY TABLET;ORAL 48.6MG A083897 Jun 21, 1974

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

BUTABARBITAL SODIUM BUTABARBITAL SODIUM SOLVAY TABLET;ORAL 97.2MG A083896 Jun 21, 1974

BUTABARBITAL SODIUM BUTABARBITAL SODIUM WATSON LABS TABLET;ORAL 15MG A085764 Oct 28, 1977

BUTABARBITAL SODIUM BUTABARBITAL SODIUM WATSON LABS TABLET;ORAL 30MG A085772 Aug 24, 1977

BUTABARBITAL SODIUM BUTABARBITAL SODIUM WHITEWORTH TOWN PLSN TABLET;ORAL 15MG A083325 Dec 06, 1976

BUTABARBITAL SODIUM BUTABARBITAL SODIUM WHITEWORTH TOWN PLSN TABLET;ORAL 30MG A083337 Jan 28, 1974

BUTABARBITAL SODIUM BUTABARBITAL SODIUM WOCKHARDT ELIXIR;ORAL 30MG/5ML A085383 Feb 26, 1979

BUTABARBITAL SODIUM BUTALAN LANNETT ELIXIR;ORAL 33.3MG/5ML A085880 Aug 30, 1978

BUTABARBITAL SODIUM BUTICAPS MEDPOINTE PHARM HLC CAPSULE;ORAL 100MG A085381 Apr 11, 1978

BUTABARBITAL SODIUM BUTICAPS MEDPOINTE PHARM HLC CAPSULE;ORAL 15MG A085381 Apr 11, 1978

BUTABARBITAL SODIUM BUTICAPS MEDPOINTE PHARM HLC CAPSULE;ORAL 30MG A085381 Apr 11, 1978

BUTABARBITAL SODIUM BUTICAPS MEDPOINTE PHARM HLC CAPSULE;ORAL 50MG A085381 Apr 11, 1978

BUTABARBITAL SODIUM BUTISOL SODIUM MEDA PHARMS ELIXIR;ORAL 30MG/5ML A085380 Apr 10, 1978

BUTABARBITAL SODIUM SARISOL HALSEY ELIXIR;ORAL 30MG/5ML A084723 Dec 01, 1981

BUTABARBITAL SODIUM SARISOL NO. 1 HALSEY TABLET;ORAL 15MG A084719 Feb 11, 1976

BUTABARBITAL SODIUM SARISOL NO. 2 HALSEY TABLET;ORAL 30MG A084719 Feb 11, 1976

BUTABARBITAL SODIUM SODIUM BUTABARBITAL HIKMA TABLET;ORAL 15MG A085418 Aug 15, 1977

BUTABARBITAL SODIUM SODIUM BUTABARBITAL HIKMA TABLET;ORAL 30MG A085432 Dec 20, 1977

BUTABARBITAL SODIUM SODIUM BUTABARBITAL IVAX SUB TEVA PHARMS TABLET;ORAL 15MG A083484 Sep 25, 1973

BUTABARBITAL SODIUM SODIUM BUTABARBITAL IVAX SUB TEVA PHARMS TABLET;ORAL 30MG A084040 May 31, 1974

BUTABARBITAL SODIUM SODIUM BUTABARBITAL LANNETT TABLET;ORAL 15MG A085849 Aug 21, 1978

BUTABARBITAL SODIUM SODIUM BUTABARBITAL LANNETT TABLET;ORAL 30MG A085866 Jul 20, 1978

BUTABARBITAL SODIUM SODIUM BUTABARBITAL LANNETT TABLET;ORAL 100MG A085881 Jul 20, 1978

BUTABARBITAL SODIUM SODIUM BUTABARBITAL MARSHALL PHARMA TABLET;ORAL 16.2MG A083524 Jan 15, 1974

BUTABARBITAL SODIUM SODIUM BUTABARBITAL MARSHALL PHARMA TABLET;ORAL 32.4MG A083858 Mar 14, 1974

CAFFEINE; ERGOTAMINE 

TARTRATE WIGRAINE ORGANON USA INC TABLET;ORAL 100MG;1MG A086562 Nov 05, 1980

CALCIUM GLUCEPTATE CALCIUM GLUCEPTATE ABBOTT

INJECTABLE;INJE

CTION

EQ 90MG 

CALCIUM/5ML A083159 Dec 04, 1972

CALCIUM GLUCEPTATE CALCIUM GLUCEPTATE ABBOTT

INJECTABLE;INJE

CTION

EQ 90MG 

CALCIUM/5ML A080001 Sep 29, 1970

CARISOPRODOL CARISOPRODOL WATSON LABS TABLET;ORAL 350MG A085433 Oct 26, 1977

CARISOPRODOL CARISOPRODOL WATSON LABS TEVA TABLET;ORAL 350MG A086179 Jun 12, 1979

CHLORDIAZEPOXIDE LIBRITABS VALEANT PHARM INTL TABLET;ORAL 10MG A085481 Sep 21, 1977

CHLORDIAZEPOXIDE LIBRITABS VALEANT PHARM INTL TABLET;ORAL 25MG A085488 Sep 21, 1977

CHLORDIAZEPOXIDE LIBRITABS VALEANT PHARM INTL TABLET;ORAL 5MG A085482 Sep 21, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE A-POXIDE ABBOTT CAPSULE;ORAL 10MG A085447 Apr 22, 1978

CHLORDIAZEPOXIDE 

HYDROCHLORIDE A-POXIDE ABBOTT CAPSULE;ORAL 10MG A085518 Jul 01, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE A-POXIDE ABBOTT CAPSULE;ORAL 25MG A085447 Apr 11, 1978

CHLORDIAZEPOXIDE 

HYDROCHLORIDE A-POXIDE ABBOTT CAPSULE;ORAL 25MG A085513 Jun 30, 1977

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE A-POXIDE ABBOTT CAPSULE;ORAL 5MG A085447 Apr 11, 1978

CHLORDIAZEPOXIDE 

HYDROCHLORIDE A-POXIDE ABBOTT CAPSULE;ORAL 5MG A085517 Jul 01, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE CHLORDIAZACHEL RACHELLE CAPSULE;ORAL 10MG A084639 May 11, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE CHLORDIAZACHEL RACHELLE CAPSULE;ORAL 25MG A085087 May 11, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE CHLORDIAZACHEL RACHELLE CAPSULE;ORAL 5MG A085086 May 11, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE ASCOT CAPSULE;ORAL 10MG A087524 Jan 07, 1982

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE ASCOT CAPSULE;ORAL 25MG A087512 Jan 07, 1982

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE ASCOT CAPSULE;ORAL 5MG A087525 Jan 07, 1982

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 10MG A084041 Jun 15, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 25MG A084679 Sep 07, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 5MG A084678 Jun 15, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE FERRANTE CAPSULE;ORAL 10MG A085119 Sep 02, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE FERRANTE CAPSULE;ORAL 25MG A085120 Sep 02, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE FERRANTE CAPSULE;ORAL 5MG A085118 Sep 02, 1981

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE HALSEY CAPSULE;ORAL 10MG A085339 May 26, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE HALSEY CAPSULE;ORAL 25MG A084685 May 16, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE HALSEY CAPSULE;ORAL 5MG A085340 May 26, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE IMPAX LABS CAPSULE;ORAL 10MG A085113 Dec 12, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE IMPAX LABS CAPSULE;ORAL 25MG A086212 Jul 10, 1979

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE IMPAX LABS CAPSULE;ORAL 5MG A086213 Jul 10, 1979

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 10MG A083742 Mar 07, 1975

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 25MG A083570 Mar 07, 1975

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 5MG A083741 Mar 07, 1975

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 10MG A087037 Mar 20, 1981

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 10MG A086876 Aug 29, 1979

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 25MG A087231 Mar 20, 1981

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 25MG A086893 Aug 30, 1979

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 5MG A087234 Mar 20, 1981

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 5MG A086892 Aug 30, 1979

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE MAST MM CAPSULE;ORAL 10MG A086217 Feb 10, 1981

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE MYLAN CAPSULE;ORAL 10MG A084601 Mar 19, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE MYLAN CAPSULE;ORAL 25MG A084887 Mar 19, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE MYLAN CAPSULE;ORAL 5MG A084886 Mar 19, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE PARKE DAVIS CAPSULE;ORAL 10MG A084598 Aug 24, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE PARKE DAVIS CAPSULE;ORAL 25MG A085164 Aug 24, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE PARKE DAVIS CAPSULE;ORAL 5MG A085163 Aug 24, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE PUREPAC PHARM CAPSULE;ORAL 10MG A084939 Jun 03, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE PUREPAC PHARM CAPSULE;ORAL 25MG A085144 Jun 30, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE PUREPAC PHARM CAPSULE;ORAL 5MG A085155 Jun 30, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE ROXANE CAPSULE;ORAL 10MG A084700 Jul 02, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE ROXANE CAPSULE;ORAL 25MG A084705 Jul 02, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE ROXANE CAPSULE;ORAL 5MG A084706 Jul 02, 1976

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE TEVA CAPSULE;ORAL 25MG A086494 Feb 04, 1981

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE UPSHER SMITH LABS CAPSULE;ORAL 10MG A084920 Jan 31, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE UPSHER SMITH LABS CAPSULE;ORAL 25MG A084823 Jan 31, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE UPSHER SMITH LABS CAPSULE;ORAL 5MG A084919 Jan 31, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE USL PHARMA CAPSULE;ORAL 10MG A084623 Feb 24, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE USL PHARMA CAPSULE;ORAL 25MG A084645 Feb 24, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE USL PHARMA CAPSULE;ORAL 5MG A084644 Feb 24, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE VANGARD CAPSULE;ORAL 10MG A088010 Mar 28, 1983

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE VANGARD CAPSULE;ORAL 25MG A088130 Mar 28, 1983

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE VANGARD CAPSULE;ORAL 5MG A088129 Mar 28, 1983

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 10MG A086294 Sep 08, 1978

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 25MG A086382 Sep 08, 1978

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 5MG A086383 Sep 08, 1978

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE WEST WARD CAPSULE;ORAL 10MG A085000 Apr 06, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE WEST WARD CAPSULE;ORAL 25MG A085294 Apr 06, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE

CHLORDIAZEPOXIDE 

HYDROCHLORIDE WEST WARD CAPSULE;ORAL 5MG A085014 Apr 06, 1977

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LYGEN ALRA CAPSULE;ORAL 10MG A085009 Apr 21, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LYGEN ALRA CAPSULE;ORAL 25MG A085108 Apr 21, 1976

CHLORDIAZEPOXIDE 

HYDROCHLORIDE LYGEN ALRA CAPSULE;ORAL 5MG A085107 Apr 21, 1976

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE HIKMA PHARMS TABLET;ORAL 250MG A083082 Jul 09, 1975

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE IMPAX LABS TABLET;ORAL 250MG A080880 Dec 11, 1974

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE MD PHARM TABLET;ORAL 250MG A087228 Sep 29, 1980

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE PUREPAC PHARM TABLET;ORAL 250MG A080886 Jun 13, 1979

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE TEVA TABLET;ORAL 250MG A087504 Jan 13, 1982

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE WATSON LABS TABLET;ORAL 250MG A087979 Dec 21, 1982

CHLOROQUINE PHOSPHATE CHLOROQUINE PHOSPHATE WATSON LABS TABLET;ORAL 500MG A088030 Dec 21, 1982

CHLOROTHIAZIDE CHLOROTHIAZIDE ABC HOLDING TABLET;ORAL 250MG A085569 Mar 08, 1978

CHLOROTHIAZIDE CHLOROTHIAZIDE HIKMA INTL PHARMS TABLET;ORAL 250MG A086028 Jul 14, 1982

CHLOROTHIAZIDE CHLOROTHIAZIDE HIKMA INTL PHARMS TABLET;ORAL 500MG A087736 Jul 14, 1982

CHLOROTHIAZIDE CHLOROTHIAZIDE LEDERLE TABLET;ORAL 250MG A086940 Mar 13, 1980

CHLOROTHIAZIDE CHLOROTHIAZIDE LEDERLE TABLET;ORAL 500MG A086938 Mar 13, 1980

CHLOROTHIAZIDE CHLOROTHIAZIDE MYLAN TABLET;ORAL 250MG A084217 Jun 26, 1975

CHLOROTHIAZIDE CHLOROTHIAZIDE MYLAN TABLET;ORAL 500MG A084217 Jul 17, 1975

CHLOROTHIAZIDE CHLOROTHIAZIDE SANDOZ TABLET;ORAL 250MG A085485 Apr 01, 1981

CHLOROTHIAZIDE CHLOROTHIAZIDE WATSON LABS TABLET;ORAL 250MG A085173 Nov 04, 1977

CHLOROTHIAZIDE CHLOROTHIAZIDE WATSON LABS TABLET;ORAL 250MG A086795 Aug 15, 1983

CHLOROTHIAZIDE CHLOROTHIAZIDE WATSON LABS TABLET;ORAL 250MG A085165 Sep 24, 1976

CHLOROTHIAZIDE CHLOROTHIAZIDE WATSON LABS TABLET;ORAL 500MG A086796 Aug 15, 1983

CHLOROTHIAZIDE CHLOROTHIAZIDE WATSON LABS TABLET;ORAL 500MG A084026 Sep 01, 1982

CHLOROTHIAZIDE; RESERPINE CHLOROTHIAZIDE AND RESERPINE HIKMA TABLET;ORAL 250MG;0.125MG A088557 Dec 22, 1983

CHLOROTHIAZIDE; RESERPINE CHLOROTHIAZIDE AND RESERPINE HIKMA TABLET;ORAL 500MG;0.125MG A088365 Dec 22, 1983

CHLOROTHIAZIDE; RESERPINE CHLOROTHIAZIDE W/ RESERPINE WATSON LABS TABLET;ORAL 250MG;0.125MG A084853 Oct 27, 1976

CHLOROTHIAZIDE; RESERPINE CHLOROTHIAZIDE W/ RESERPINE WATSON LABS TABLET;ORAL 500MG;0.125MG A088151 Jun 09, 1983

CHLOROTHIAZIDE; RESERPINE CHLOROTHIAZIDE-RESERPINE MYLAN TABLET;ORAL 250MG;0.125MG A087744 May 06, 1982

CHLOROTHIAZIDE; RESERPINE CHLOROTHIAZIDE-RESERPINE MYLAN TABLET;ORAL 500MG;0.125MG A087745 May 06, 1982

CHLOROTRIANISENE CHLOROTRIANISENE BANNER PHARMACAPS CAPSULE;ORAL 12MG A084652 Aug 07, 1975

CHLORPHENIRAMINE MALEATE ANTAGONATE BAYER PHARMS TABLET;ORAL 4MG A083381 Mar 20, 1973

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE ANABOLIC TABLET;ORAL 4MG A083078 Nov 02, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE AUROLIFE PHARMA LLC TABLET;ORAL 4MG A080961 Dec 20, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE BEL MAR

INJECTABLE;INJE

CTION 10MG/ML A080821 Nov 29, 1973

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE BELL PHARMA TABLET;ORAL 4MG A083062 May 06, 1974

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE ELKINS SINN

INJECTABLE;INJE

CTION 10MG/ML A080797 Sep 12, 1973

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE ELKINS SINN TABLET;ORAL 4MG A080938 Oct 16, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE IMPAX LABS TABLET;ORAL 4MG A080809 Feb 04, 1974

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE IVAX SUB TEVA PHARMS TABLET;ORAL 4MG A080779 May 09, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE KV PHARM TABLET;ORAL 4MG A087164 Jul 22, 1981

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE LEDERLE TABLET;ORAL 4MG A086941 Mar 13, 1980

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE NEWTRON PHARMS TABLET;ORAL 4MG A086519 Feb 09, 1979

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PANRAY TABLET;ORAL 4MG A083243 Jul 09, 1974

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PHARM ASSOC SYRUP;ORAL 2MG/5ML A087520 Feb 10, 1982

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PHARMAVITE TABLET;ORAL 4MG A085104 Feb 11, 1977

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PHARMERAL TABLET;ORAL 4MG A083753 Jun 21, 1974

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PIONEER PHARMS TABLET;ORAL 4MG A088556 Jul 13, 1984

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PUREPAC PHARM TABLET;ORAL 4MG A086306 Aug 09, 1979

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE PVT FORM TABLET;ORAL 4MG A080786 Sep 15, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE ROXANE TABLET;ORAL 4MG A080626 May 01, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE SUN PHARM INDUSTRIES TABLET;ORAL 4MG A080700 Aug 24, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE VITARINE TABLET;ORAL 4MG A085837 Nov 02, 1978

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A086095 Oct 05, 1979

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WATSON LABS

INJECTABLE;INJE

CTION 10MG/ML A086096 Oct 09, 1979

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WATSON LABS

INJECTABLE;INJE

CTION 10MG/ML A083593 Jul 05, 1977

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WATSON LABS TABLET;ORAL 4MG A080696 Oct 18, 1974

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WATSON LABS TABLET;ORAL 4MG A085139 Jul 26, 1976

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WATSON LABS TABLET;ORAL 4MG A080791 Aug 21, 1972

CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE MALEATE WEST WARD TABLET;ORAL 4MG A083787 Oct 18, 1973

CHLORPHENIRAMINE MALEATE KLOROMIN HALSEY TABLET;ORAL 4MG A083629 Jul 29, 1976

CHLORPHENIRAMINE MALEATE PHENETRON LANNETT TABLET;ORAL 4MG A080846 Jun 13, 1974

CHLORPHENIRAMINE MALEATE PYRIDAMAL 100 BEL MAR

INJECTABLE;INJE

CTION 100MG/ML A083733 Jan 23, 1979

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 10MG A084414 Jan 28, 1975

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 200MG A084413 Jan 28, 1975

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 25MG A084415 Jan 28, 1975

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 50MG A084411 Jan 28, 1975

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 100MG A084412 Mar 20, 1975

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 25MG/ML A084911 Dec 08, 1977

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC

CONCENTRATE;ORA

L 100MG/ML A086863 Nov 07, 1980

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE ALPHARMA US PHARMS SYRUP;ORAL 10MG/5ML A086712 Nov 10, 1980

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CYCLE PHARMS LTD TABLET;ORAL 10MG A085331 Oct 15, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CYCLE PHARMS LTD TABLET;ORAL 200MG A085331 Oct 15, 1976

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CYCLE PHARMS LTD TABLET;ORAL 25MG A085331 Oct 15, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CYCLE PHARMS LTD TABLET;ORAL 50MG A085331 Oct 15, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE CYCLE PHARMS LTD TABLET;ORAL 100MG A085331 Oct 15, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 25MG/ML A080365 Feb 13, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 10MG A083549 May 06, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 200MG A083575 May 06, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG A083549 May 06, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 50MG A083549 May 06, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 100MG A083574 May 06, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 10MG A085750 Jan 04, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 200MG A085748 Jan 04, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 25MG A085751 Feb 06, 1978

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 50MG A085484 Feb 06, 1978

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 100MG A085752 Feb 06, 1978

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE LEDERLE TABLET;ORAL 200MG A084802 Mar 16, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE LEDERLE TABLET;ORAL 25MG A084801 Mar 16, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE LEDERLE TABLET;ORAL 50MG A084800 Mar 16, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE LEDERLE TABLET;ORAL 10MG A084803 Mar 16, 1972

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE LEDERLE TABLET;ORAL 100MG A084789 Mar 24, 1976

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 10MG A080403 Jun 13, 1977

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 200MG A080403 Jun 13, 1977

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 25MG A080403 Sep 30, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 50MG A080403 Sep 30, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 100MG A080403 Sep 30, 1974

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PVT FORM TABLET;ORAL 200MG A080340 Apr 09, 1979

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PVT FORM TABLET;ORAL 25MG A080340 Apr 09, 1979

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE PVT FORM TABLET;ORAL 50MG A080340 Apr 09, 1979

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 100MG A080439 Jan 03, 1973

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 10MG A080439 Jan 03, 1973

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 200MG A080439 Jan 03, 1973

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 25MG A080439 Jan 03, 1973

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 50MG A080439 Jan 03, 1973

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE VANGARD TABLET;ORAL 10MG A088038 Aug 16, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE VANGARD TABLET;ORAL 25MG A087645 Dec 14, 1981

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE VANGARD TABLET;ORAL 50MG A087646 Dec 14, 1981

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A085591 Jul 01, 1977

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A085959 Dec 17, 1980

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 200MG A085958 Dec 17, 1980

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A085956 Nov 16, 1979

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085960 Nov 19, 1979

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 100MG A085957 Dec 17, 1980

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 10MG A087783 Sep 16, 1982

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 200MG A087880 Sep 16, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 25MG A087865 Sep 16, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 50MG A087878 Sep 15, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 100MG A087884 Sep 15, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WOCKHARDT

CONCENTRATE;ORA

L 100MG/ML A087053 Feb 04, 1981

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WOCKHARDT

CONCENTRATE;ORA

L 30MG/ML A087032 Jul 08, 1982

CHLORPROMAZINE 

HYDROCHLORIDE CHLORPROMAZINE HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 25MG/ML A080370 Jul 26, 1972

CHLORPROMAZINE 

HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE 

INTENSOL HIKMA

CONCENTRATE;ORA

L 100MG/ML A088158 Apr 27, 1983

CHLORPROMAZINE 

HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE 

INTENSOL HIKMA

CONCENTRATE;ORA

L 30MG/ML A088157 Apr 27, 1983

CHLORPROMAZINE 

HYDROCHLORIDE PROMAPAR PARKE DAVIS TABLET;ORAL 10MG A086886 Aug 13, 1980

CHLORPROMAZINE 

HYDROCHLORIDE PROMAPAR PARKE DAVIS TABLET;ORAL 200MG A086885 Aug 13, 1980

CHLORPROMAZINE 

HYDROCHLORIDE PROMAPAR PARKE DAVIS TABLET;ORAL 25MG A084423 Aug 13, 1980

CHLORPROMAZINE 

HYDROCHLORIDE PROMAPAR PARKE DAVIS TABLET;ORAL 50MG A086887 Aug 13, 1980

CHLORPROMAZINE 

HYDROCHLORIDE PROMAPAR PARKE DAVIS TABLET;ORAL 100MG A086888 Aug 13, 1980

CHLORPROMAZINE 

HYDROCHLORIDE SONAZINE FOSUN PHARMA

CONCENTRATE;ORA

L 100MG/ML A080983 May 26, 1976

CHLORPROMAZINE 

HYDROCHLORIDE SONAZINE FOSUN PHARMA

CONCENTRATE;ORA

L 30MG/ML A080983 May 26, 1976

CHLORPROMAZINE 

HYDROCHLORIDE SONAZINE FOSUN PHARMA SYRUP;ORAL 10MG/5ML A083040 Mar 04, 1976

CHLORPROPAMIDE CHLORPROPAMIDE ANI PHARMS TABLET;ORAL 250MG A087353 Jun 26, 1981

CHLORPROPAMIDE CHLORPROPAMIDE MYLAN TABLET;ORAL 100MG A088549 Jun 01, 1984

CHLORPROPAMIDE CHLORPROPAMIDE MYLAN TABLET;ORAL 250MG A088549 Jun 01, 1984

CHLORPROPAMIDE CHLORPROPAMIDE PAR PHARM TABLET;ORAL 100MG A088175 Feb 27, 1984

CHLORPROPAMIDE CHLORPROPAMIDE PAR PHARM TABLET;ORAL 250MG A088176 Feb 27, 1984

CHLORPROPAMIDE CHLORPROPAMIDE RISING TABLET;ORAL 100MG A088725 Aug 31, 1984

CHLORPROPAMIDE CHLORPROPAMIDE RISING TABLET;ORAL 250MG A088726 Aug 31, 1984

CHLORPROPAMIDE CHLORPROPAMIDE SANDOZ TABLET;ORAL 250MG A084669 Jul 10, 1980

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORPROPAMIDE CHLORPROPAMIDE SUPERPHARM TABLET;ORAL 100MG A088694 Sep 17, 1984

CHLORPROPAMIDE CHLORPROPAMIDE SUPERPHARM TABLET;ORAL 250MG A088695 Sep 17, 1984

CHLORPROPAMIDE CHLORPROPAMIDE USL PHARMA TABLET;ORAL 100MG A088708 Aug 30, 1984

CHLORPROPAMIDE CHLORPROPAMIDE USL PHARMA TABLET;ORAL 250MG A088709 Aug 30, 1984

CHLORPROPAMIDE CHLORPROPAMIDE WATSON LABS TABLET;ORAL 100MG A088608 Apr 12, 1984

CHLORPROPAMIDE CHLORPROPAMIDE WATSON LABS TABLET;ORAL 100MG A086865 Sep 24, 1984

CHLORPROPAMIDE CHLORPROPAMIDE WATSON LABS TABLET;ORAL 250MG A086866 Oct 03, 1980

CHLORPROPAMIDE CHLORPROPAMIDE WATSON LABS TABLET;ORAL 250MG A088568 Apr 12, 1984

CHLORTHALIDONE CHLORTHALIDONE ABBOTT TABLET;ORAL 25MG A087364 Mar 06, 1981

CHLORTHALIDONE CHLORTHALIDONE ABBOTT TABLET;ORAL 50MG A087384 Mar 06, 1981

CHLORTHALIDONE CHLORTHALIDONE ANI PHARMS TABLET;ORAL 25MG A088164 Jan 09, 1984

CHLORTHALIDONE CHLORTHALIDONE ANI PHARMS TABLET;ORAL 25MG A087296 Aug 19, 1981

CHLORTHALIDONE CHLORTHALIDONE ANI PHARMS TABLET;ORAL 25MG A087706 Sep 16, 1981

CHLORTHALIDONE CHLORTHALIDONE ANI PHARMS TABLET;ORAL 50MG A087689 Sep 16, 1981

CHLORTHALIDONE CHLORTHALIDONE ASCOT TABLET;ORAL 25MG A087698 Oct 20, 1982

CHLORTHALIDONE CHLORTHALIDONE ASCOT TABLET;ORAL 50MG A087699 Oct 20, 1982

CHLORTHALIDONE CHLORTHALIDONE DAVA PHARMS INC TABLET;ORAL 25MG A087451 Apr 03, 1981

CHLORTHALIDONE CHLORTHALIDONE DAVA PHARMS INC TABLET;ORAL 50MG A087450 Apr 03, 1981

CHLORTHALIDONE CHLORTHALIDONE IVAX PHARMS TABLET;ORAL 25MG A087555 Jun 24, 1981

CHLORTHALIDONE CHLORTHALIDONE IVAX PHARMS TABLET;ORAL 50MG A087947 Feb 27, 1984

CHLORTHALIDONE CHLORTHALIDONE IVAX PHARMS TABLET;ORAL 50MG A087176 Apr 13, 1981

CHLORTHALIDONE CHLORTHALIDONE KV PHARM TABLET;ORAL 25MG A087311 Mar 11, 1981

CHLORTHALIDONE CHLORTHALIDONE KV PHARM TABLET;ORAL 50MG A087312 Mar 11, 1981

CHLORTHALIDONE CHLORTHALIDONE MUTUAL PHARM TABLET;ORAL 25MG A087292 Mar 05, 1981

CHLORTHALIDONE CHLORTHALIDONE MUTUAL PHARM TABLET;ORAL 50MG A087293 Mar 05, 1981

CHLORTHALIDONE CHLORTHALIDONE PUREPAC PHARM TABLET;ORAL 50MG A088140 Aug 11, 1983

CHLORTHALIDONE CHLORTHALIDONE SANDOZ TABLET;ORAL 25MG A087380 May 01, 1981

CHLORTHALIDONE CHLORTHALIDONE SANDOZ TABLET;ORAL 50MG A087381 May 01, 1981

CHLORTHALIDONE CHLORTHALIDONE SANDOZ TABLET;ORAL 50MG A087118 Jun 15, 1981

CHLORTHALIDONE CHLORTHALIDONE SUPERPHARM TABLET;ORAL 25MG A087473 Feb 09, 1983

CHLORTHALIDONE CHLORTHALIDONE SUPERPHARM TABLET;ORAL 50MG A087247 Feb 09, 1983

CHLORTHALIDONE CHLORTHALIDONE VANGARD TABLET;ORAL 25MG A088012 Jul 14, 1982

CHLORTHALIDONE CHLORTHALIDONE VANGARD TABLET;ORAL 50MG A088073 Mar 25, 1983

CHLORTHALIDONE CHLORTHALIDONE WARNER CHILCOTT TABLET;ORAL 25MG A087515 Jan 24, 1983

CHLORTHALIDONE CHLORTHALIDONE WARNER CHILCOTT TABLET;ORAL 50MG A087516 Feb 09, 1983

CHLORTHALIDONE CHLORTHALIDONE WATSON LABS TABLET;ORAL 25MG A087050 Mar 20, 1981

CHLORTHALIDONE CHLORTHALIDONE WATSON LABS TABLET;ORAL 25MG A087100 Aug 25, 1981

CHLORTHALIDONE CHLORTHALIDONE WATSON LABS TABLET;ORAL 50MG A087029 Mar 20, 1981

CHLORTHALIDONE CHLORTHALIDONE WATSON LABS TABLET;ORAL 50MG A087521 Aug 19, 1981

CHLORTHALIDONE CHLORTHALIDONE WATSON LABS TABLET;ORAL 50MG A087082 Aug 25, 1981

CHLORTHALIDONE THALITONE MONARCH PHARMS TABLET;ORAL 25MG A088051 Nov 12, 1982

CHLORZOXAZONE CHLORZOXAZONE PAR PHARM TABLET;ORAL 250MG A087981 Sep 20, 1983

CHLORZOXAZONE CHLORZOXAZONE WATSON LABS TABLET;ORAL 250MG A086901 Oct 06, 1981

Current as of July 2021 Page 41 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CHLORZOXAZONE CHLORZOXAZONE WATSON LABS TABLET;ORAL 250MG A086948 Aug 09, 1982

COLCHICINE; PROBENECID PROBEN-C WATSON LABS TABLET;ORAL 0.5MG;500MG A085552 Sep 15, 1977

COLCHICINE; PROBENECID PROBENECID AND COLCHICINE ANI PHARMS TABLET;ORAL 0.5MG;500MG A083734 Jun 12, 1978

COLCHICINE; PROBENECID PROBENECID AND COLCHICINE BEECHAM TABLET;ORAL 0.5MG;500MG A084321 Mar 11, 1976

COLCHICINE; PROBENECID PROBENECID AND COLCHICINE IMPAX LABS TABLET;ORAL 0.5MG;500MG A083720 Sep 06, 1977

COLCHICINE; PROBENECID PROBENECID AND COLCHICINE SANDOZ TABLET;ORAL 0.5MG;500MG A086130 Mar 18, 1980

COLCHICINE; PROBENECID PROBENECID W/ COLCHICINE LEDERLE TABLET;ORAL 0.5MG;500MG A086954 Sep 06, 1979

COLCHICINE; PROBENECID PROBENECID W/ COLCHICINE WATSON LABS TABLET;ORAL 0.5MG;500MG A083221 Apr 07, 1975

CORTISONE ACETATE CORTISONE ACETATE BARR TABLET;ORAL 25MG A083471 Aug 31, 1973

CORTISONE ACETATE CORTISONE ACETATE ELKINS SINN TABLET;ORAL 25MG A080836 Jan 26, 1973

CORTISONE ACETATE CORTISONE ACETATE EVERYLIFE TABLET;ORAL 25MG A084246 Jan 22, 1975

CORTISONE ACETATE CORTISONE ACETATE HEATHER TABLET;ORAL 25MG A085736 Jun 27, 1977

CORTISONE ACETATE CORTISONE ACETATE INWOOD LABS TABLET;ORAL 25MG A080731 Jul 26, 1972

CORTISONE ACETATE CORTISONE ACETATE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG A080630 Jan 03, 1972

CORTISONE ACETATE CORTISONE ACETATE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG A083536 Jul 09, 1973

CORTISONE ACETATE CORTISONE ACETATE LANNETT TABLET;ORAL 25MG A080694 Oct 17, 1974

CORTISONE ACETATE CORTISONE ACETATE PUREPAC PHARM TABLET;ORAL 25MG A080493 Aug 21, 1972

CORTISONE ACETATE CORTISONE ACETATE VITARINE TABLET;ORAL 25MG A080333 Dec 22, 1971

CORTISONE ACETATE CORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A083147 Feb 11, 1977

CORTISONE ACETATE CORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A085677 Mar 07, 1978

CORTISONE ACETATE CORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A083147 Feb 11, 1977

CORTISONE ACETATE CORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A085677 Mar 07, 1978

CORTISONE ACETATE CORTISONE ACETATE WATSON LABS TABLET;ORAL 25MG A085884 May 15, 1978

CORTISONE ACETATE CORTISONE ACETATE WHITEWORTH TOWN PLSN TABLET;ORAL 25MG A080341 Jun 20, 1973

CYANOCOBALAMIN BETALIN 12 LILLY

INJECTABLE;INJE

CTION 0.1MG/ML A080855 Jul 09, 1973

CYANOCOBALAMIN BETALIN 12 LILLY

INJECTABLE;INJE

CTION 1MG/ML A080855 Jul 09, 1973

CYANOCOBALAMIN COBAVITE WATSON LABS

INJECTABLE;INJE

CTION 0.1MG/ML A083013 Sep 25, 1972

CYANOCOBALAMIN COBAVITE WATSON LABS

INJECTABLE;INJE

CTION 1MG/ML A083064 Nov 03, 1972

CYANOCOBALAMIN CYANOCOBALAMIN ABRAXIS PHARM

INJECTABLE;INJE

CTION 0.1MG/ML A080510 Dec 12, 1972

CYANOCOBALAMIN CYANOCOBALAMIN ABRAXIS PHARM

INJECTABLE;INJE

CTION 1MG/ML A080510 Dec 12, 1972

CYANOCOBALAMIN CYANOCOBALAMIN ABRAXIS PHARM

INJECTABLE;INJE

CTION 0.03MG/ML A080510 Jul 05, 1973

Current as of July 2021 Page 42 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CYANOCOBALAMIN CYANOCOBALAMIN AKORN

INJECTABLE;INJE

CTION 1MG/ML A087969 Nov 10, 1983

CYANOCOBALAMIN CYANOCOBALAMIN DELL LABS

INJECTABLE;INJE

CTION 0.1MG/ML A080689 Jun 22, 1973

CYANOCOBALAMIN CYANOCOBALAMIN DELL LABS

INJECTABLE;INJE

CTION 1MG/ML A080689 Jun 22, 1973

CYANOCOBALAMIN CYANOCOBALAMIN DELL LABS

INJECTABLE;INJE

CTION 0.03MG/ML A080689 Jun 22, 1973

CYANOCOBALAMIN CYANOCOBALAMIN DR REDDYS

INJECTABLE;INJE

CTION 0.1MG/ML A080573 Jan 29, 1974

CYANOCOBALAMIN CYANOCOBALAMIN DR REDDYS

INJECTABLE;INJE

CTION 1MG/ML A080573 Jan 29, 1974

CYANOCOBALAMIN CYANOCOBALAMIN FRESENIUS KABI USA

INJECTABLE;INJE

CTION 0.1MG/ML A080557 Jun 20, 1973

CYANOCOBALAMIN CYANOCOBALAMIN LUITPOLD

INJECTABLE;INJE

CTION 0.03MG/ML A080668 Apr 26, 1972

CYANOCOBALAMIN CYANOCOBALAMIN LYPHOMED

INJECTABLE;INJE

CTION 1MG/ML A083075 Sep 12, 1979

CYANOCOBALAMIN CYANOCOBALAMIN SANOFI AVENTIS US

INJECTABLE;INJE

CTION 1MG/ML A080564 Oct 12, 1973

CYANOCOBALAMIN CYANOCOBALAMIN SOLOPAK

INJECTABLE;INJE

CTION 1MG/ML A087551 Feb 29, 1984

CYANOCOBALAMIN CYANOCOBALAMIN WATSON LABS

INJECTABLE;INJE

CTION 0.1MG/ML A083120 Jul 01, 1977

CYANOCOBALAMIN CYANOCOBALAMIN WATSON LABS

INJECTABLE;INJE

CTION 1MG/ML A083120 Jul 01, 1977

CYANOCOBALAMIN CYANOCOBALAMIN WEST WARD TABLET;ORAL 1MG A084264 Dec 10, 1974

CYANOCOBALAMIN CYANOCOBALAMIN WYETH AYERST

INJECTABLE;INJE

CTION 0.1MG/ML A080554 Mar 21, 1973

CYANOCOBALAMIN CYANOCOBALAMIN WYETH AYERST

INJECTABLE;INJE

CTION 1MG/ML A080554 Mar 21, 1973

CYANOCOBALAMIN DODEX ACCORD HLTHCARE

INJECTABLE;INJE

CTION 1MG/ML A083022 Sep 20, 1972

CYANOCOBALAMIN RUVITE SAVAGE LABS

INJECTABLE;INJE

CTION 1MG/ML A080570 Oct 02, 1977

CYCLOPENTOLATE 

HYDROCHLORIDE AK-PENTOLATE AKORN

SOLUTION/DROPS;

OPHTHALMIC 1% A085555 Apr 10, 1979

CYCLOPENTOLATE 

HYDROCHLORIDE CYCLOPENTOLATE HYDROCHLORIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 1% A084863 Jan 16, 1976

CYCLOPENTOLATE 

HYDROCHLORIDE CYCLOPENTOLATE HYDROCHLORIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 1% A084150 Nov 22, 1974

Current as of July 2021 Page 43 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CYCLOPENTOLATE 

HYDROCHLORIDE PENTOLAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 1% A088150 Feb 25, 1983

CYCLOPHOSPHAMIDE NEOSAR BEDFORD

INJECTABLE;INJE

CTION 100MG/VIAL A087442 Feb 16, 1982

CYCLOPHOSPHAMIDE NEOSAR BEDFORD

INJECTABLE;INJE

CTION 1GM/VIAL A087442 Jul 08, 1983

CYCLOPHOSPHAMIDE NEOSAR BEDFORD

INJECTABLE;INJE

CTION 200MG/VIAL A087442 Feb 16, 1982

CYCLOPHOSPHAMIDE NEOSAR BEDFORD

INJECTABLE;INJE

CTION 500MG/VIAL A087442 Feb 16, 1982

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE ACTAVIS MID ATLANTIC SYRUP;ORAL 2MG/5ML A086833 Apr 16, 1980

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE ASCOT TABLET;ORAL 4MG A087685 Oct 25, 1982

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 4MG A088212 May 26, 1983

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE DURAMED PHARMS BARR TABLET;ORAL 4MG A088232 Oct 25, 1983

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE FOSUN PHARMA TABLET;ORAL 4MG A086808 Feb 24, 1981

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE KV PHARM TABLET;ORAL 4MG A086737 Oct 14, 1980

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE MD PHARM TABLET;ORAL 4MG A087566 Nov 10, 1982

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE MORTON GROVE SYRUP;ORAL 2MG/5ML A087001 Nov 04, 1982

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE MYLAN TABLET;ORAL 4MG A086678 Apr 23, 1979

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE PAR PHARM TABLET;ORAL 4MG A087129 Jul 09, 1981

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE PIONEER PHARMS TABLET;ORAL 4MG A087839 Feb 08, 1984

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE PLIVA TABLET;ORAL 4MG A088205 Jul 26, 1983

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE SUPERPHARM TABLET;ORAL 4MG A087405 May 18, 1981

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE VITARINE TABLET;ORAL 4MG A087284 Aug 04, 1981

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 4MG A085245 Jun 23, 1978

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 4MG A086580 Sep 14, 1981

Current as of July 2021 Page 44 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

CYPROHEPTADINE 

HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 4MG A086165 Sep 20, 1978

DESERPIDINE; 

METHYCLOTHIAZIDE

METHYCLOTHIAZIDE AND 

DESERPIDINE WATSON LABS TABLET;ORAL 0.25MG;5MG A088486 Aug 10, 1984

DESERPIDINE; 

METHYCLOTHIAZIDE

METHYCLOTHIAZIDE AND 

DESERPIDINE WATSON LABS TABLET;ORAL 0.5MG;5MG A088452 Aug 10, 1984

DEXAMETHASONE AEROSEB-DEX ALLERGAN HERBERT AEROSOL;TOPICAL 0.01% A083296 Jun 15, 1973

DEXAMETHASONE DEXAMETHASONE ANI PHARMS TABLET;ORAL 0.75MG A080399 Oct 20, 1971

DEXAMETHASONE DEXAMETHASONE HERITAGE PHARMA TABLET;ORAL 1.5MG A085456 Feb 08, 1977

DEXAMETHASONE DEXAMETHASONE IMPAX LABS TABLET;ORAL 0.75MG A085376 Mar 04, 1977

DEXAMETHASONE DEXAMETHASONE PAR PHARM TABLET;ORAL 0.25MG A088149 Apr 28, 1983

DEXAMETHASONE DEXAMETHASONE PHOENIX LABS NY TABLET;ORAL 0.75MG A083806 Sep 09, 1974

DEXAMETHASONE DEXAMETHASONE PVT FORM TABLET;ORAL 0.75MG A083420 Sep 01, 1976

DEXAMETHASONE DEXAMETHASONE ROXANE TABLET;ORAL 0.25MG A084614 Jul 25, 1975

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 0.5MG A084766 Mar 23, 1978

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 0.5MG A084084 Jul 10, 1974

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 0.25MG A084764 Mar 23, 1978

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 0.25MG A084013 Jun 21, 1974

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 0.75MG A084765 Mar 23, 1978

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 0.75MG A084081 Jul 03, 1974

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 1.5MG A084763 Mar 23, 1978

DEXAMETHASONE DEXAMETHASONE SUN PHARM INDUSTRIES TABLET;ORAL 1.5MG A084086 Jun 27, 1974

DEXAMETHASONE DEXAMETHASONE UPSHER SMITH TABLET;ORAL 0.75MG A087534 Oct 23, 1981

DEXAMETHASONE DEXAMETHASONE UPSHER SMITH TABLET;ORAL 1.5MG A087533 Oct 23, 1981

DEXAMETHASONE DEXAMETHASONE WATSON LABS TABLET;ORAL 0.75MG A085818 Oct 21, 1977

DEXAMETHASONE DEXAMETHASONE WATSON LABS TABLET;ORAL 0.75MG A084457 Feb 18, 1975

DEXAMETHASONE DEXAMETHASONE WATSON LABS TABLET;ORAL 1.5MG A085840 Oct 25, 1977

DEXAMETHASONE DEXAMETHASONE WATSON LABS TABLET;ORAL 0.25MG A085455 Feb 08, 1977

DEXAMETHASONE DEXAMETHASONE WATSON LABS TABLET;ORAL 0.5MG A085458 Feb 08, 1977

DEXAMETHASONE DEXAMETHASONE WATSON LABS TABLET;ORAL 0.75MG A080968 May 03, 1973

DEXAMETHASONE DEXAMETHASONE WHITEWORTH TOWN PLSN TABLET;ORAL 0.75MG A084327 Feb 18, 1975

DEXAMETHASONE DEXONE 0.5 SOLVAY TABLET;ORAL 0.5MG A084991 Dec 18, 1975

DEXAMETHASONE DEXONE 0.75 SOLVAY TABLET;ORAL 0.75MG A084993 Dec 18, 1975

DEXAMETHASONE DEXONE 1.5 SOLVAY TABLET;ORAL 1.5MG A084990 Dec 18, 1975

DEXAMETHASONE DEXONE 4 SOLVAY TABLET;ORAL 4MG A084992 Dec 18, 1975

DEXAMETHASONE ACETATE DEXAMETHASONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION EQ 8MG BASE/ML A084315 Nov 08, 1978

DEXAMETHASONE ACETATE DEXAMETHASONE ACETATE WATSON LABS TEVA

INJECTABLE;INJE

CTION

EQ 16MG 

BASE/ML A087711 May 24, 1982

DEXAMETHASONE SODIUM 

PHOSPHATE DEXACEN-4 CENT PHARMS

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A084342 Oct 19, 1976

Current as of July 2021 Page 45 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DEXAMETHASONE SODIUM 

PHOSPHATE DEXAIR PHARMAFAIR

OINTMENT;OPHTHA

LMIC

EQ 0.05% 

PHOSPHATE A088071 Dec 28, 1982

DEXAMETHASONE SODIUM 

PHOSPHATE DEXAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.1% 

PHOSPHATE A088433 Dec 15, 1983

DEXAMETHASONE SODIUM 

PHOSPHATE DEXAMETHASONE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A088448 Jan 25, 1984

DEXAMETHASONE SODIUM 

PHOSPHATE DEXAMETHASONE FRESENIUS KABI USA

INJECTABLE;INJE

CTION

EQ 10MG 

PHOSPHATE/ML A088469 Jan 25, 1984

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE AKORN

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A084493 Aug 08, 1975

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE AKORN

SOLUTION/DROPS;

OTIC

EQ 0.1% 

PHOSPHATE A084855 Jun 29, 1976

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE BEL MAR

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A084752 Mar 15, 1979

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE DELL LABS

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A083161 Jun 06, 1978

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE INTL MEDICATION

INJECTABLE;INJE

CTION

EQ 20MG 

PHOSPHATE/ML A088522 Feb 17, 1984

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE LUITPOLD

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A087440 Jul 21, 1982

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE LYPHOMED

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A087065 May 29, 1981

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.1% 

PHOSPHATE A084170 Dec 19, 1974

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.1% 

PHOSPHATE A084173 Feb 18, 1975

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 10MG 

PHOSPHATE/ML A087668 Jul 01, 1982

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A083702 Jan 28, 1974

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A084355 Jul 13, 1977

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 24MG 

PHOSPHATE/ML A085606 Jun 19, 1980

DEXAMETHASONE SODIUM 

PHOSPHATE

DEXAMETHASONE SODIUM 

PHOSPHATE WYETH AYERST

INJECTABLE;INJE

CTION

EQ 4MG 

PHOSPHATE/ML A085641 Sep 28, 1977

DEXAMETHASONE SODIUM 

PHOSPHATE MAXIDEX ALCON

OINTMENT;OPHTHA

LMIC

EQ 0.05% 

PHOSPHATE A083342 Oct 23, 1973

DEXCHLORPHENIRAMINE MALEATE POLARAMINE SCHERING SYRUP;ORAL 2MG/5ML A086837 Jul 19, 1982

DEXCHLORPHENIRAMINE MALEATE POLARAMINE SCHERING TABLET;ORAL 2MG A086835 Jul 14, 1981

Current as of July 2021 Page 46 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DEXTROAMPHETAMINE SULFATE DEXAMPEX TEVA CAPSULE;ORAL 15MG A085355 Aug 18, 1980

DEXTROAMPHETAMINE SULFATE DEXAMPEX TEVA TABLET;ORAL 10MG A083735 Nov 11, 1975

DEXTROAMPHETAMINE SULFATE DEXAMPEX TEVA TABLET;ORAL 5MG A083735 Nov 11, 1975

DEXTROAMPHETAMINE SULFATE DEXEDRINE GLAXOSMITHKLINE ELIXIR;ORAL 5MG/5ML A083902 Feb 26, 1976

DEXTROAMPHETAMINE SULFATE DEXEDRINE GLAXOSMITHKLINE TABLET;ORAL 5MG A084935 Feb 26, 1976

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE ANI PHARMS TABLET;ORAL 5MG A085370 Feb 22, 1977

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE HALSEY TABLET;ORAL 10MG A083930 Oct 29, 1975

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE LANNETT TABLET;ORAL 10MG A083903 Jun 09, 1976

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE LANNETT TABLET;ORAL 5MG A083903 Oct 29, 1975

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE LANNETT TABLET;ORAL 15MG A085652 Jun 20, 1980

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE MAST MM TABLET;ORAL 5MG A086521 Mar 13, 1979

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE PUREPAC PHARM TABLET;ORAL 5MG A084125 Sep 19, 1978

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE SANDOZ TABLET;ORAL 10MG A085371 Feb 18, 1977

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE VITARINE TABLET;ORAL 10MG A085892 Apr 18, 1979

DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE VITARINE TABLET;ORAL 5MG A084986 Dec 07, 1976

DEXTROAMPHETAMINE SULFATE DEXTROSTAT SHIRE TABLET;ORAL 10MG A084051 May 29, 1975

DEXTROAMPHETAMINE SULFATE DEXTROSTAT SHIRE TABLET;ORAL 5MG A084051 May 29, 1975

DEXTROAMPHETAMINE SULFATE FERNDEX FERNDALE LABS TABLET;ORAL 5MG A084001 Jun 15, 1977

DIATRIZOATE MEGLUMINE ANGIOVIST 282 BAYER HLTHCARE

INJECTABLE;INJE

CTION 60% A087726 Sep 23, 1982

DIATRIZOATE MEGLUMINE UROVIST CYSTO BAYER HLTHCARE

SOLUTION;URETER

AL 30% A087729 Sep 23, 1982

DIATRIZOATE MEGLUMINE UROVIST CYSTO PEDIATRIC BAYER HLTHCARE

SOLUTION;URETER

AL 30% A087731 Sep 23, 1982

DIATRIZOATE MEGLUMINE UROVIST MEGLUMINE DIU/CT BAYER HLTHCARE

INJECTABLE;INJE

CTION 30% A087739 Sep 23, 1982

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM ANGIOVIST 292 BAYER HLTHCARE

INJECTABLE;INJE

CTION 52%;8% A087724 Sep 23, 1982

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM ANGIOVIST 370 BAYER HLTHCARE

INJECTABLE;INJE

CTION 66%;10% A087723 Sep 23, 1982

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM DIATRIZOATE-60 INTL MEDICATION

INJECTABLE;INJE

CTION 52%;8% A088166 Jun 17, 1983

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM GASTROVIST BAYER HLTHCARE

SOLUTION;ORAL, 

RECTAL 66%;10% A087728 Sep 23, 1982

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM HYPAQUE-76 GE HEALTHCARE

INJECTABLE;INJE

CTION 66%;10% A086505 Jul 02, 1980

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM MD-60 MALLINCKRODT

INJECTABLE;INJE

CTION 52%;8% A087074 Oct 09, 1980

DIATRIZOATE MEGLUMINE; 

DIATRIZOATE SODIUM MD-76 MALLINCKRODT

INJECTABLE;INJE

CTION 66%;10% A087073 Oct 09, 1980

DIATRIZOATE SODIUM MD-50 MALLINCKRODT

INJECTABLE;INJE

CTION 50% A087075 Oct 09, 1980

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DIATRIZOATE SODIUM UROVIST SODIUM 300 BAYER HLTHCARE

INJECTABLE;INJE

CTION 50% A087725 Sep 23, 1982

DICYCLOMINE HYDROCHLORIDE DICYCLOMINE HYDROCHLORIDE ALPHARMA US PHARMS SYRUP;ORAL 10MG/5ML A084479 Oct 30, 1975

DIENESTROL DV SANOFI AVENTIS US CREAM;VAGINAL 0.01% A083518 Nov 02, 1978

DIENESTROL DV SANOFI AVENTIS US

SUPPOSITORY;VAG

INAL 0.7MG A083517 Nov 02, 1978

DIENESTROL ESTRAGUARD SOLVAY CREAM;VAGINAL 0.01% A084436 Nov 04, 1975

DIETHYLPROPION 

HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 25MG A088267 Aug 25, 1983

DIETHYLPROPION 

HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 25MG A088268 Aug 25, 1983

DIETHYLPROPION 

HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE SANDOZ TABLET;ORAL 25MG A085916 Jul 19, 1979

DIETHYLPROPION 

HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE TEVA TABLET;ORAL 25MG A088642 Sep 20, 1984

DIETHYLPROPION 

HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE UCB INC TABLET;ORAL 25MG A085544 Sep 26, 1978

DIETHYLPROPION 

HYDROCHLORIDE DIETHYLPROPION HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A085741 Aug 15, 1979

DIETHYLSTILBESTROL STILBESTROL TABLICAPS

TABLET, DELAYED 

RELEASE;ORAL 0.5MG A083003 May 30, 1973

DIETHYLSTILBESTROL STILBESTROL TABLICAPS

TABLET, DELAYED 

RELEASE;ORAL 1MG A083005 Jun 12, 1973

DIETHYLSTILBESTROL STILBESTROL TABLICAPS

TABLET, DELAYED 

RELEASE;ORAL 5MG A083007 May 30, 1973

DIETHYLSTILBESTROL STILBESTROL TABLICAPS TABLET;ORAL 0.5MG A083004 May 30, 1973

DIETHYLSTILBESTROL STILBESTROL TABLICAPS TABLET;ORAL 1MG A083002 May 30, 1973

DIETHYLSTILBESTROL STILBESTROL TABLICAPS TABLET;ORAL 5MG A083006 May 30, 1973

DIGITOXIN CRYSTODIGIN LILLY

INJECTABLE;INJE

CTION 0.2MG/ML A084100 Aug 28, 1978

DIGOXIN DIGOXIN ABRAXIS PHARM

INJECTABLE;INJE

CTION 0.25MG/ML A083217 Jun 30, 1976

DIGOXIN DIGOXIN WYETH AYERST

INJECTABLE;INJE

CTION 0.25MG/ML A084386 Jul 12, 1976

DIMENHYDRINATE DIMENHYDRINATE ALRA LIQUID;ORAL 12.5MG/4ML A080715 May 31, 1972

DIMENHYDRINATE DIMENHYDRINATE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 50MG/ML A084767 Sep 13, 1976

DIMENHYDRINATE DIMENHYDRINATE HEATHER TABLET;ORAL 50MG A080841 Nov 06, 1974

DIMENHYDRINATE DIMENHYDRINATE NEXGEN PHARMA INC TABLET;ORAL 50MG A085985 Dec 19, 1977

Current as of July 2021 Page 48 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DIMENHYDRINATE DIMENHYDRINATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A083531 Jul 05, 1977

DIMENHYDRINATE DIMENHYDRINATE WATSON LABS TABLET;ORAL 50MG A085166 Nov 08, 1976

DIMENHYDRINATE DIMENHYDRINATE WATSON LABS TEVA

INJECTABLE;INJE

CTION 50MG/ML A080615 Jan 29, 1974

DIMENHYDRINATE DIMENHYDRINATE WYETH AYERST

INJECTABLE;INJE

CTION 50MG/ML A084316 Aug 18, 1975

DIPHENHYDRAMINE 

HYDROCHLORIDE BELIX HALSEY ELIXIR;ORAL 12.5MG/5ML A086586 Oct 03, 1983

DIPHENHYDRAMINE 

HYDROCHLORIDE DIBENIL CENCI ELIXIR;ORAL 12.5MG/5ML A088304 Dec 16, 1983

DIPHENHYDRAMINE 

HYDROCHLORIDE DIPHEN USL PHARMA ELIXIR;ORAL 12.5MG/5ML A084640 Feb 26, 1979

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ALRA CAPSULE;ORAL 25MG A080519 Feb 02, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ALRA CAPSULE;ORAL 50MG A080519 Feb 02, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ANABOLIC CAPSULE;ORAL 50MG A083275 Nov 28, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 10MG/ML A080822 Jan 25, 1979

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE BUNDY ELIXIR;ORAL 12.5MG/5ML A083674 Jun 12, 1975

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE CENCI ELIXIR;ORAL 12.5MG/5ML A087941 Dec 17, 1982

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 50MG/ML A080873 Jan 29, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 10MG/ML A080873 Jan 29, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ELKINS SINN CAPSULE;ORAL 25MG A085701 Jul 25, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ELKINS SINN CAPSULE;ORAL 50MG A085701 Jul 25, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE EUROHLTH INTL SARL

INJECTABLE;INJE

CTION 50MG/ML A083183 Oct 12, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE FOSUN PHARMA CAPSULE;ORAL 25MG A080832 Nov 03, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE FOSUN PHARMA CAPSULE;ORAL 25MG A080845 May 31, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE FOSUN PHARMA CAPSULE;ORAL 50MG A080832 Nov 03, 1972

Current as of July 2021 Page 49 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE FOSUN PHARMA CAPSULE;ORAL 50MG A080845 May 31, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE HALSEY CAPSULE;ORAL 50MG A087914 Jun 04, 1984

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE HEATHER CAPSULE;ORAL 25MG A084524 Apr 15, 1975

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE HEATHER CAPSULE;ORAL 50MG A083953 Apr 25, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE HERITAGE PHARMA CAPSULE;ORAL 50MG A080738 Aug 24, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE HERITAGE PHARMA CAPSULE;ORAL 50MG A080727 Sep 27, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE HIKMA INTL PHARMS CAPSULE;ORAL 50MG A083567 Oct 23, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE IMPAX LABS CAPSULE;ORAL 25MG A080807 Nov 14, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE IMPAX LABS CAPSULE;ORAL 50MG A080807 Nov 14, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 25MG A080762 May 09, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 50MG A080762 May 09, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE KV PHARM ELIXIR;ORAL 12.5MG/5ML A085621 Sep 22, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LANNETT CAPSULE;ORAL 25MG A080868 Feb 13, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LANNETT CAPSULE;ORAL 50MG A080868 Feb 13, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LANNETT ELIXIR;ORAL 12.5MG/5ML A080939 Jul 29, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 25MG A086874 Jan 31, 1980

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LEDERLE CAPSULE;ORAL 50MG A086875 Jan 30, 1980

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LEDERLE ELIXIR;ORAL 12.5MG/5ML A086937 Mar 13, 1980

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LNK CAPSULE;ORAL 25MG A087977 Jan 27, 1983

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LNK CAPSULE;ORAL 50MG A087978 Jan 27, 1983

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE LYPHOMED

INJECTABLE;INJE

CTION 10MG/ML A087066 Mar 31, 1981

Current as of July 2021 Page 50 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE MK LABS CAPSULE;ORAL 25MG A083087 Jan 12, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE MK LABS CAPSULE;ORAL 50MG A083087 Jan 12, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE MK LABS ELIXIR;ORAL 12.5MG/5ML A083088 Mar 26, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE MUTUAL PHARM CAPSULE;ORAL 25MG A084506 Dec 19, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE NEWTRON PHARMS CAPSULE;ORAL 25MG A086543 Feb 08, 1979

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE NEWTRON PHARMS CAPSULE;ORAL 50MG A086544 Feb 08, 1979

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE NEXGEN PHARMA INC CAPSULE;ORAL 25MG A083634 Oct 12, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PERRIGO CAPSULE;ORAL 25MG A083061 Sep 09, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PERRIGO CAPSULE;ORAL 50MG A083061 Sep 09, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PERRIGO ELIXIR;ORAL 12.5MG/5ML A083063 Jun 24, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PUREPAC PHARM CAPSULE;ORAL 25MG A085156 Aug 24, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PUREPAC PHARM CAPSULE;ORAL 50MG A085150 Aug 24, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PUREPAC PHARM ELIXIR;ORAL 12.5MG/5ML A083237 Jan 25, 1982

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PVT FORM CAPSULE;ORAL 25MG A083027 Jul 22, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PVT FORM CAPSULE;ORAL 50MG A083027 Jul 22, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PVT FORM ELIXIR;ORAL 12.5MG/5ML A085287 Mar 02, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ROXANE CAPSULE;ORAL 50MG A080635 Apr 26, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE ROXANE ELIXIR;ORAL 12.5MG/5ML A080643 Dec 20, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE TEVA CAPSULE;ORAL 25MG A085874 Oct 30, 1979

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE TEVA CAPSULE;ORAL 50MG A085874 Oct 30, 1979

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE VALEANT PHARM INTL CAPSULE;ORAL 25MG A080596 Mar 10, 1972

Current as of July 2021 Page 51 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE VALEANT PHARM INTL CAPSULE;ORAL 50MG A080592 Jan 18, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE VANGARD CAPSULE;ORAL 25MG A088034 Oct 27, 1982

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE VANGARD CAPSULE;ORAL 50MG A087630 Dec 07, 1981

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 25MG A083797 Feb 13, 1975

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 25MG A080728 Feb 28, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 25MG A085138 Jul 29, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 50MG A083797 Feb 13, 1975

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 50MG A085083 Jun 29, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 10MG/ML A083533 Jul 05, 1977

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WHITEWORTH TOWN PLSN CAPSULE;ORAL 25MG A083441 Nov 12, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WHITEWORTH TOWN PLSN CAPSULE;ORAL 50MG A080800 Aug 13, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 50MG/ML A080577 Aug 07, 1972

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PRESERVATIVE 

FREE ABRAXIS PHARM

INJECTABLE;INJE

CTION 50MG/ML A080586 Jan 10, 1973

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PRESERVATIVE 

FREE DR REDDYS

INJECTABLE;INJE

CTION 50MG/ML A080873 Jan 29, 1974

DIPHENHYDRAMINE 

HYDROCHLORIDE

DIPHENHYDRAMINE 

HYDROCHLORIDE PRESERVATIVE 

FREE INTL MEDICATION

INJECTABLE;INJE

CTION 50MG/ML A084094 Mar 15, 1976

DIPHENHYDRAMINE 

HYDROCHLORIDE HYDRAMINE ALPHARMA US PHARMS ELIXIR;ORAL 12.5MG/5ML A080763 Jul 06, 1977

DISULFIRAM DISULFIRAM PAR PHARM TABLET;ORAL 250MG A088792 Aug 14, 1984

DISULFIRAM DISULFIRAM PAR PHARM TABLET;ORAL 500MG A088793 Aug 14, 1984

DISULFIRAM DISULFIRAM WATSON LABS TABLET;ORAL 250MG A086889 Mar 31, 1981

DISULFIRAM DISULFIRAM WATSON LABS TABLET;ORAL 250MG A087973 Aug 05, 1983

DISULFIRAM DISULFIRAM WATSON LABS TABLET;ORAL 500MG A087974 Aug 05, 1983

DISULFIRAM DISULFIRAM WATSON LABS TEVA TABLET;ORAL 500MG A086890 Mar 31, 1981

DOXYLAMINE SUCCINATE DOXYLAMINE SUCCINATE QUANTUM PHARMICS TABLET;ORAL 25MG A088603 Aug 07, 1984

Current as of July 2021 Page 52 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

DYPHYLLINE DILOR SAVAGE LABS TABLET;ORAL 200MG A084514 Aug 16, 1976

DYPHYLLINE DILOR-400 SAVAGE LABS TABLET;ORAL 400MG A084751 Aug 16, 1976

DYPHYLLINE LUFYLLIN MYLAN SPECIALITY LP TABLET;ORAL 200MG A084566 Aug 16, 1976

DYPHYLLINE LUFYLLIN MYLAN SPECIALITY LP TABLET;ORAL 400MG A084566 Aug 16, 1976

EPINEPHRINE EPINEPHRINE ARMSTRONG PHARMS

AEROSOL, 

METERED;INHALAT

ION 0.2MG/INH A087907 May 23, 1984

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

ALPHACAINE HYDROCHLORIDE W/ 

EPINEPHRINE CARLISLE

INJECTABLE;INJE

CTION 0.01MG/ML;2% A084720 Jan 16, 1976

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

ALPHACAINE HYDROCHLORIDE W/ 

EPINEPHRINE CARLISLE

INJECTABLE;INJE

CTION 0.02MG/ML;2% A084732 Jan 21, 1976

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND 

EPINEPHRINE BELMORA LLC

INJECTABLE;INJE

CTION 0.01MG/ML;2% A080504 Oct 19, 1983

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND 

EPINEPHRINE BELMORA LLC

INJECTABLE;INJE

CTION 0.02MG/ML;2% A080504 Oct 19, 1983

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND 

EPINEPHRINE WEST-WARD PHARMS INT

INJECTABLE;INJE

CTION 0.01MG/ML;1% A080406 Mar 13, 1972

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE AND 

EPINEPHRINE WEST-WARD PHARMS INT

INJECTABLE;INJE

CTION 0.01MG/ML;2% A080406 Mar 13, 1972

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE ABBOTT

INJECTABLE;INJE

CTION 0.01MG/ML;1% A083154 Dec 20, 1972

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE BEL MAR

INJECTABLE;INJE

CTION 0.01MG/ML;1% A080820 Dec 03, 1973

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE BEL MAR

INJECTABLE;INJE

CTION 0.01MG/ML;2% A080757 Dec 03, 1973

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE DELL LABS

INJECTABLE;INJE

CTION 0.01MG/ML;1% A083389 Mar 18, 1975

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE DELL LABS

INJECTABLE;INJE

CTION 0.01MG/ML;2% A083390 Mar 18, 1975

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE INTL MEDICATION

INJECTABLE;INJE

CTION 0.01MG/ML;1% A086402 Feb 04, 1980

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE WATSON LABS

INJECTABLE;INJE

CTION 0.01MG/ML;1% A080377 Feb 20, 1974

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE WATSON LABS

INJECTABLE;INJE

CTION 0.01MG/ML;1% A085463 Jul 21, 1977

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE W/ 

EPINEPHRINE WATSON LABS

INJECTABLE;INJE

CTION 0.01MG/ML;2% A080377 Feb 20, 1974

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE LIDOCATON PHARMATON

INJECTABLE;INJE

CTION 0.01MG/ML;2% A084729 Aug 17, 1983

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE LIDOCATON PHARMATON

INJECTABLE;INJE

CTION 0.02MG/ML;2% A084728 Aug 17, 1983

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE OCTOCAINE SEPTODONT

INJECTABLE;INJE

CTION 0.01MG/ML;2% A084048 Sep 09, 1980

EPINEPHRINE; LIDOCAINE 

HYDROCHLORIDE OCTOCAINE SEPTODONT

INJECTABLE;INJE

CTION 0.02MG/ML;2% A084048 Sep 09, 1980

EPINEPHRINE; PROCAINE 

HYDROCHLORIDE

PROCAINE HYDROCHLORIDE W/ 

EPINEPHRINE BEL MAR

INJECTABLE;INJE

CTION 0.02MG/ML;1% A080758 Dec 03, 1973

EPINEPHRINE; PROCAINE 

HYDROCHLORIDE

PROCAINE HYDROCHLORIDE W/ 

EPINEPHRINE BEL MAR

INJECTABLE;INJE

CTION 0.02MG/ML;2% A080759 Nov 26, 1973

ERGOCALCIFEROL DELTALIN LILLY CAPSULE;ORAL 50,000 IU A080884 Jun 12, 1973

ERGOCALCIFEROL VITAMIN D CHASE CHEM CAPSULE;ORAL 50,000 IU A080747 Aug 21, 1972

ERGOCALCIFEROL VITAMIN D EVERYLIFE CAPSULE;ORAL 50,000 IU A080956 Feb 22, 1973

ERGOCALCIFEROL VITAMIN D IMPAX LABS CAPSULE;ORAL 50,000 IU A080951 Jul 13, 1973

ERGOCALCIFEROL VITAMIN D LANNETT CAPSULE;ORAL 50,000 IU A080825 Sep 26, 1974

ERGOCALCIFEROL VITAMIN D VITARINE CAPSULE;ORAL 50,000 IU A084053 Mar 26, 1974

ERGOCALCIFEROL VITAMIN D WEST WARD CAPSULE;ORAL 50,000 IU A083102 Mar 26, 1973

ERGOLOID MESYLATES ALKERGOT SANDOZ

TABLET;SUBLINGU

AL 0.5MG A085153 Mar 09, 1981

ERGOLOID MESYLATES ALKERGOT SANDOZ

TABLET;SUBLINGU

AL 1MG A087417 Mar 09, 1981

ERGOLOID MESYLATES CIRCANOL 3M

TABLET;SUBLINGU

AL 0.5MG A084868 Dec 28, 1976

ERGOLOID MESYLATES CIRCANOL 3M

TABLET;SUBLINGU

AL 1MG A085809 Dec 28, 1977

ERGOLOID MESYLATES DEAPRIL-ST BRISTOL MYERS SQUIBB

TABLET;SUBLINGU

AL 1MG A085020 Jan 15, 1981

ERGOLOID MESYLATES ERGOLOID MESYLATES KV PHARM

TABLET;SUBLINGU

AL 0.5MG A086265 Jan 08, 1981

ERGOLOID MESYLATES ERGOLOID MESYLATES KV PHARM

TABLET;SUBLINGU

AL 0.5MG A085899 Feb 23, 1978

ERGOLOID MESYLATES ERGOLOID MESYLATES KV PHARM

TABLET;SUBLINGU

AL 1MG A086264 Jan 08, 1981

ERGOLOID MESYLATES ERGOLOID MESYLATES KV PHARM

TABLET;SUBLINGU

AL 1MG A085900 Feb 23, 1978

ERGOLOID MESYLATES ERGOLOID MESYLATES LEDERLE

TABLET;SUBLINGU

AL 0.5MG A086984 Aug 02, 1979

ERGOLOID MESYLATES ERGOLOID MESYLATES LEDERLE

TABLET;SUBLINGU

AL 1MG A086985 Aug 02, 1979

ERGOLOID MESYLATES ERGOLOID MESYLATES SUN PHARM INDUSTRIES

TABLET;SUBLINGU

AL 0.5MG A087407 Aug 11, 1981

ERGOLOID MESYLATES ERGOLOID MESYLATES SUN PHARM INDUSTRIES

TABLET;SUBLINGU

AL 1MG A087552 Aug 11, 1981

Current as of July 2021 Page 54 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ERGOLOID MESYLATES ERGOLOID MESYLATES VANGARD

TABLET;SUBLINGU

AL 0.5MG A088013 Sep 20, 1982

ERGOLOID MESYLATES ERGOLOID MESYLATES VANGARD

TABLET;SUBLINGU

AL 1MG A088014 Sep 20, 1982

ERGOLOID MESYLATES ERGOLOID MESYLATES WATSON LABS TABLET;ORAL 1MG A086433 May 27, 1982

ERGOLOID MESYLATES ERGOLOID MESYLATES WATSON LABS TABLET;ORAL 1MG A087244 Aug 16, 1982

ERGOLOID MESYLATES ERGOLOID MESYLATES WATSON LABS

TABLET;SUBLINGU

AL 0.5MG A084930 Dec 28, 1976

ERGOLOID MESYLATES ERGOLOID MESYLATES WATSON LABS

TABLET;SUBLINGU

AL 0.5MG A087233 Apr 16, 1981

ERGOLOID MESYLATES ERGOLOID MESYLATES WATSON LABS

TABLET;SUBLINGU

AL 1MG A087183 Apr 16, 1981

ERGOLOID MESYLATES ERGOLOID MESYLATES WATSON LABS

TABLET;SUBLINGU

AL 1MG A085177 Aug 26, 1977

ERGOLOID MESYLATES GERIMAL WATSON LABS TABLET;ORAL 1MG A088207 Mar 22, 1984

ERGOLOID MESYLATES GERIMAL WATSON LABS

TABLET;SUBLINGU

AL 0.5MG A086189 Jul 07, 1980

ERGOLOID MESYLATES GERIMAL WATSON LABS

TABLET;SUBLINGU

AL 1MG A086188 Jul 07, 1980

ERGOLOID MESYLATES HYDROGENATED ERGOT ALKALOIDS IVAX PHARMS

TABLET;SUBLINGU

AL 0.5MG A087186 Nov 20, 1980

ERGOLOID MESYLATES HYDROGENATED ERGOT ALKALOIDS IVAX PHARMS

TABLET;SUBLINGU

AL 1MG A087185 Nov 20, 1980

ERGOTAMINE TARTRATE ERGOSTAT WATSON LABS INC

TABLET;SUBLINGU

AL 2MG A088337 Jun 08, 1984

ERGOTAMINE TARTRATE WIGRETTES ORGANON USA INC

TABLET;SUBLINGU

AL 2MG A086750 Jul 29, 1982

ESTRADIOL ESTRACE BRISTOL MYERS SQUIBB TABLET;ORAL 1MG A084499 Jul 28, 1975

ESTRADIOL ESTRACE BRISTOL MYERS SQUIBB TABLET;ORAL 2MG A084500 Jul 23, 1975

ESTRADIOL CYPIONATE DEPO-ESTRADIOL PFIZER

INJECTABLE;INJE

CTION 1MG/ML A085470 Aug 15, 1979

ESTRADIOL CYPIONATE DEPO-ESTRADIOL PFIZER

INJECTABLE;INJE

CTION 3MG/ML A085470 Aug 15, 1979

ESTRADIOL CYPIONATE ESTRADIOL CYPIONATE DR REDDYS

INJECTABLE;INJE

CTION 5MG/ML A085620 Nov 02, 1981

ESTRADIOL VALERATE ESTRADIOL VALERATE DR REDDYS

INJECTABLE;INJE

CTION 20MG/ML A083547 Feb 28, 1979

ESTRADIOL VALERATE ESTRADIOL VALERATE DR REDDYS

INJECTABLE;INJE

CTION 40MG/ML A083714 Feb 28, 1979

ESTRADIOL VALERATE ESTRADIOL VALERATE WATSON LABS

INJECTABLE;INJE

CTION 10MG/ML A083546 Feb 28, 1979

Current as of July 2021 Page 55 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ESTRADIOL VALERATE; 

TESTOSTERONE ENANTHATE DITATE-DS SAVAGE LABS

INJECTABLE;INJE

CTION

8MG/ML;180MG/M

L A086423 Sep 24, 1979

ESTRADIOL VALERATE; 

TESTOSTERONE ENANTHATE

TESTOSTERONE ENANTHATE AND 

ESTRADIOL VALERATE WATSON LABS

INJECTABLE;INJE

CTION 4MG/ML;90MG/ML A085865 May 07, 1981

ESTRADIOL VALERATE; 

TESTOSTERONE ENANTHATE

TESTOSTERONE ENANTHATE AND 

ESTRADIOL VALERATE WATSON LABS

INJECTABLE;INJE

CTION

8MG/ML;180MG/M

L A085860 May 07, 1981

ESTROGENS, ESTERIFIED AMNESTROGEN BRISTOL MYERS SQUIBB TABLET;ORAL 0.3MG A083266 Feb 20, 1974

ESTROGENS, ESTERIFIED AMNESTROGEN BRISTOL MYERS SQUIBB TABLET;ORAL 0.625MG A083266 Feb 20, 1974

ESTROGENS, ESTERIFIED AMNESTROGEN BRISTOL MYERS SQUIBB TABLET;ORAL 1.25MG A083266 Feb 20, 1974

ESTROGENS, ESTERIFIED AMNESTROGEN BRISTOL MYERS SQUIBB TABLET;ORAL 2.5MG A083266 Feb 20, 1974

ESTROGENS, ESTERIFIED ESTERIFIED ESTROGENS PVT FORM TABLET;ORAL 0.625MG A083414 Apr 20, 1977

ESTROGENS, ESTERIFIED ESTERIFIED ESTROGENS PVT FORM TABLET;ORAL 1.25MG A083765 Apr 20, 1977

ESTROGENS, ESTERIFIED ESTERIFIED ESTROGENS PVT FORM TABLET;ORAL 2.5MG A085907 Aug 12, 1977

ESTROGENS, ESTERIFIED ESTERIFIED ESTROGENS SANDOZ TABLET;ORAL 1.25MG A085302 Jul 25, 1977

ESTROGENS, ESTERIFIED ESTRATAB SOLVAY TABLET;ORAL 0.3MG A086715 Apr 08, 1981

ESTROGENS, ESTERIFIED ESTRATAB SOLVAY TABLET;ORAL 0.625MG A083209 Jun 17, 1977

ESTROGENS, ESTERIFIED ESTRATAB SOLVAY TABLET;ORAL 1.25MG A083856 Jun 17, 1977

ESTROGENS, ESTERIFIED ESTRATAB SOLVAY TABLET;ORAL 2.5MG A083857 Jun 17, 1977

ESTROGENS, ESTERIFIED EVEX ROCHE PALO TABLET;ORAL 0.625MG A084215 Sep 28, 1977

ESTROGENS, ESTERIFIED EVEX ROCHE PALO TABLET;ORAL 1.25MG A083376 Sep 28, 1977

ESTROGENS, ESTERIFIED FEMOGEN PVT FORM TABLET;ORAL 0.625MG A085076 Apr 20, 1977

ESTROGENS, ESTERIFIED FEMOGEN PVT FORM TABLET;ORAL 1.25MG A085008 Apr 20, 1977

ESTROGENS, ESTERIFIED FEMOGEN PVT FORM TABLET;ORAL 2.5MG A085007 Apr 20, 1977

ESTRONE ESTROGENIC SUBSTANCE WYETH AYERST

INJECTABLE;INJE

CTION 2MG/ML A083488 Jun 12, 1979

ESTRONE ESTRONE DR REDDYS

INJECTABLE;INJE

CTION 5MG/ML A085239 Feb 21, 1979

ESTRONE ESTRONE WATSON LABS

INJECTABLE;INJE

CTION 2MG/ML A083397 Feb 21, 1979

ESTRONE

NATURAL ESTROGENIC SUBSTANCEESTRONE WATSON LABSINJECTABLE;INJE

CTION 2MG/ML A085237 Nov 23, 1982

ESTROPIPATE OGEN PHARMACIA AND UPJOHN CREAM;VAGINAL 1.5MG/GM A084710 Jun 03, 1977

ESTROPIPATE OGEN .625 PFIZER TABLET;ORAL 0.75MG A083220 May 19, 1977

ESTROPIPATE OGEN 1.25 PFIZER TABLET;ORAL 1.5MG A083220 May 19, 1977

ESTROPIPATE OGEN 2.5 PFIZER TABLET;ORAL 3MG A083220 May 19, 1977

ETHCHLORVYNOL ETHCHLORVYNOL BANNER PHARMACAPS CAPSULE;ORAL 100MG A084463 Jan 13, 1976

ETHCHLORVYNOL ETHCHLORVYNOL BANNER PHARMACAPS CAPSULE;ORAL 200MG A084463 Jan 13, 1976

ETHCHLORVYNOL ETHCHLORVYNOL BANNER PHARMACAPS CAPSULE;ORAL 500MG A084463 Jan 13, 1976

ETHCHLORVYNOL ETHCHLORVYNOL BANNER PHARMACAPS CAPSULE;ORAL 750MG A084463 Jan 13, 1976

FLUOCINOLONE ACETONIDE FLUOCET ALPHARMA US PHARMS CREAM;TOPICAL 0.025% A088360 Jan 16, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE ALPHARMA US PHARMS CREAM;TOPICAL 0.01% A088361 Jan 16, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE ALPHARMA US PHARMS

SOLUTION;TOPICA

L 0.01% A087159 Jun 16, 1982

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE INVATECH CREAM;TOPICAL 0.01% A088047 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE INVATECH CREAM;TOPICAL 0.025% A088045 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE INVATECH

SOLUTION;TOPICA

L 0.01% A088048 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE MORTON GROVE

SOLUTION;TOPICA

L 0.01% A088312 Jan 27, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PERRIGO NEW YORK CREAM;TOPICAL 0.01% A086810 Mar 04, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PERRIGO NEW YORK CREAM;TOPICAL 0.025% A086811 Mar 04, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PHARMADERM

OINTMENT;TOPICA

L 0.025% A088046 Dec 16, 1982

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PHARMAFAIR CREAM;TOPICAL 0.01% A088499 Aug 02, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PHARMAFAIR CREAM;TOPICAL 0.025% A088506 Aug 02, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PHARMAFAIR

OINTMENT;TOPICA

L 0.025% A088507 Feb 27, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE PHARMAFAIR

SOLUTION;TOPICA

L 0.01% A088449 Feb 08, 1984

FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE TARO CREAM;TOPICAL 0.01% A087102 Apr 27, 1982

FLUOCINOLONE ACETONIDE FLUONID ALLERGAN HERBERT CREAM;TOPICAL 0.025% A087156 Sep 06, 1984

FLUOCINOLONE ACETONIDE FLUONID ALLERGAN HERBERT GEL;TOPICAL 0.025% A087300 May 27, 1982

FLUOCINOLONE ACETONIDE FLUONID ALLERGAN HERBERT

OINTMENT;TOPICA

L 0.025% A087157 Sep 06, 1984

FLUOCINOLONE ACETONIDE FLUONID ALLERGAN HERBERT

SOLUTION;TOPICA

L 0.01% A087158 Mar 17, 1983

FLUOCINOLONE ACETONIDE FLUOTREX SAVAGE LABS CREAM;TOPICAL 0.01% A088174 May 06, 1983

FLUOCINOLONE ACETONIDE FLUOTREX SAVAGE LABS CREAM;TOPICAL 0.025% A088173 Mar 09, 1983

FLUOCINOLONE ACETONIDE FLUOTREX SAVAGE LABS

OINTMENT;TOPICA

L 0.025% A088172 Mar 09, 1983

FLUOCINOLONE ACETONIDE FLUOTREX SAVAGE LABS

SOLUTION;TOPICA

L 0.01% A088171 Mar 09, 1983

FLUOROURACIL FLUOROURACIL MARCHAR

INJECTABLE;INJE

CTION 50MG/ML A087791 Jan 18, 1983

FLUOROURACIL FLUOROURACIL SPECTRUM PHARMS

INJECTABLE;INJE

CTION 50MG/ML A087792 Oct 13, 1982

FLUOXYMESTERONE ANDROID-F VALEANT PHARM INTL TABLET;ORAL 10MG A087196 Jul 06, 1981

FLUOXYMESTERONE FLUOXYMESTERONE UPSHER SMITH LABS TABLET;ORAL 10MG A088342 Oct 21, 1983

FLUOXYMESTERONE FLUOXYMESTERONE VALEANT PHARM INTL TABLET;ORAL 10MG A088221 May 05, 1983

FLUOXYMESTERONE FLUOXYMESTERONE WATSON LABS TABLET;ORAL 10MG A088309 Dec 06, 1983

FLUOXYMESTERONE FLUOXYMESTERONE WATSON LABS TABLET;ORAL 2MG A088260 Dec 06, 1983

FLUOXYMESTERONE FLUOXYMESTERONE WATSON LABS TABLET;ORAL 5MG A088265 Dec 06, 1983

FLURANDRENOLIDE FLURANDRENOLIDE ALPHARMA US PHARMS LOTION;TOPICAL 0.05% A087203 Apr 29, 1982

FOLIC ACID FOLIC ACID CONTRACT PHARMACAL TABLET;ORAL 1MG A085061 Jul 29, 1976

FOLIC ACID FOLIC ACID EVERYLIFE TABLET;ORAL 1MG A080755 Mar 20, 1973

Current as of July 2021 Page 57 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

FOLIC ACID FOLIC ACID HALSEY TABLET;ORAL 1MG A083598 Aug 31, 1973

FOLIC ACID FOLIC ACID HIKMA PHARMS TABLET;ORAL 1MG A080600 Mar 31, 1972

FOLIC ACID FOLIC ACID IMPAX LABS TABLET;ORAL 1MG A080686 Jul 20, 1973

FOLIC ACID FOLIC ACID IVAX SUB TEVA PHARMS TABLET;ORAL 1MG A083000 Oct 02, 1972

FOLIC ACID FOLIC ACID LANNETT TABLET;ORAL 1MG A080816 May 06, 1974

FOLIC ACID FOLIC ACID MK LABS TABLET;ORAL 1MG A083526 Nov 13, 1973

FOLIC ACID FOLIC ACID NEXGEN PHARMA INC TABLET;ORAL 1MG A084915 Feb 04, 1976

FOLIC ACID FOLIC ACID PHARMERAL TABLET;ORAL 1MG A084158 May 08, 1974

FOLIC ACID FOLIC ACID PUREPAC PHARM TABLET;ORAL 1MG A080784 Nov 02, 1972

FOLIC ACID FOLIC ACID SANDOZ TABLET;ORAL 1MG A084472 Jun 16, 1976

FOLIC ACID FOLIC ACID TABLICAPS TABLET;ORAL 1MG A083133 Dec 22, 1976

FOLIC ACID FOLIC ACID UDL TABLET;ORAL 1MG A088199 Mar 29, 1983

FOLIC ACID FOLIC ACID USL PHARMA TABLET;ORAL 1MG A087828 May 13, 1982

FOLIC ACID FOLIC ACID VALEANT PHARM INTL TABLET;ORAL 1MG A080903 Mar 02, 1973

FOLIC ACID FOLIC ACID VANGARD TABLET;ORAL 1MG A088730 Mar 23, 1984

FOLIC ACID FOLIC ACID VINTAGE PHARMS TABLET;ORAL 1MG A086296 Mar 18, 1980

FOLIC ACID FOLIC ACID WATSON LABS TABLET;ORAL 1MG A085141 Dec 22, 1981

FOLIC ACID FOLIC ACID WATSON LABS TABLET;ORAL 1MG A083141 Feb 15, 1973

FOLIC ACID FOLIC ACID WHITEWORTH TOWN PLSN TABLET;ORAL 1MG A080691 Jul 31, 1973

FOLIC ACID FOLICET MISSION PHARMA TABLET;ORAL 1MG A087438 Jul 30, 1981

GENTIAN VIOLET GENAPAX KEY PHARMS TAMPON;VAGINAL 5MG A085017 Feb 02, 1977

GENTIAN VIOLET GVS SAVAGE LABS

SUPPOSITORY;VAG

INAL 0.4% A083513 Jan 18, 1977

GLUTETHIMIDE GLUTETHIMIDE LANNETT TABLET;ORAL 250MG A083475 Apr 01, 1977

GLUTETHIMIDE GLUTETHIMIDE LANNETT TABLET;ORAL 500MG A085571 Aug 26, 1977

GLUTETHIMIDE GLUTETHIMIDE UCB INC TABLET;ORAL 500MG A085171 Dec 22, 1976

GLUTETHIMIDE GLUTETHIMIDE UPSHER SMITH LABS TABLET;ORAL 500MG A083234 Oct 28, 1976

GLUTETHIMIDE GLUTETHIMIDE VITARINE TABLET;ORAL 500MG A087297 Apr 20, 1981

GLUTETHIMIDE GLUTETHIMIDE WATSON LABS TABLET;ORAL 500MG A084362 Aug 01, 1977

GLUTETHIMIDE GLUTETHIMIDE WATSON LABS TABLET;ORAL 500MG A085763 Aug 02, 1977

GLYCOPYRROLATE GLYCOPYRROLATE ABRAXIS PHARM

INJECTABLE;INJE

CTION 0.2MG/ML A088475 Jun 12, 1984

GLYCOPYRROLATE GLYCOPYRROLATE WATSON LABS

INJECTABLE;INJE

CTION 0.2MG/ML A086947 Jun 24, 1983

GLYCOPYRROLATE GLYCOPYRROLATE WATSON LABS TABLET;ORAL 1MG A085562 Apr 10, 1978

GLYCOPYRROLATE GLYCOPYRROLATE WATSON LABS TABLET;ORAL 1MG A086902 Aug 25, 1981

GLYCOPYRROLATE GLYCOPYRROLATE WATSON LABS TABLET;ORAL 2MG A085563 Oct 17, 1977

GLYCOPYRROLATE GLYCOPYRROLATE WATSON LABS TABLET;ORAL 2MG A086178 Dec 13, 1978

GLYCOPYRROLATE GLYCOPYRROLATE WATSON LABS TABLET;ORAL 2MG A086900 Aug 25, 1981

HALOTHANE HALOTHANE BH

LIQUID;INHALATI

ON 99.99% A084977 Jul 14, 1976

HALOTHANE HALOTHANE HALOCARBON

LIQUID;INHALATI

ON 99.99% A080810 May 09, 1972

Current as of July 2021 Page 58 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HALOTHANE HALOTHANE HOSPIRA

LIQUID;INHALATI

ON 99.99% A083254 May 30, 1975

HEPARIN SODIUM HEPARIN LOCK FLUSH INTL MEDICATION

INJECTABLE;INJE

CTION 500 UNITS/ML A086357 Mar 13, 1979

HEPARIN SODIUM HEPARIN LOCK FLUSH INTL MEDICATION

INJECTABLE;INJE

CTION 10 UNITS/ML A086357 Mar 13, 1979

HEPARIN SODIUM HEPARIN LOCK FLUSH SMITH AND NEPHEW

INJECTABLE;INJE

CTION 10 UNITS/ML A087904 Apr 20, 1983

HEPARIN SODIUM HEPARIN LOCK FLUSH SMITH AND NEPHEW

INJECTABLE;INJE

CTION 10 UNITS/ML A087958 Apr 20, 1983

HEPARIN SODIUM HEPARIN LOCK FLUSH SMITH AND NEPHEW

INJECTABLE;INJE

CTION 10 UNITS/ML A088458 Jul 26, 1984

HEPARIN SODIUM HEPARIN LOCK FLUSH SMITH AND NEPHEW

INJECTABLE;INJE

CTION 100 UNITS/ML A087906 Apr 20, 1983

HEPARIN SODIUM HEPARIN LOCK FLUSH SMITH AND NEPHEW

INJECTABLE;INJE

CTION 100 UNITS/ML A087959 Apr 20, 1983

HEPARIN SODIUM HEPARIN LOCK FLUSH SMITH AND NEPHEW

INJECTABLE;INJE

CTION 100 UNITS/ML A088460 Jul 26, 1984

HEPARIN SODIUM HEPARIN LOCK FLUSH SOLOPAK

INJECTABLE;INJE

CTION 10 UNITS/ML A087903 Apr 20, 1983

HEPARIN SODIUM HEPARIN LOCK FLUSH SOLOPAK

INJECTABLE;INJE

CTION 100 UNITS/ML A087905 Apr 20, 1983

HEPARIN SODIUM HEPARIN LOCK FLUSH SOLOPAK

INJECTABLE;INJE

CTION 100 UNITS/ML A088459 Jul 26, 1984

HEPARIN SODIUM HEPARIN SODIUM HOSPIRA

INJECTABLE;INJE

CTION 2,500 UNITS/ML A088099 Apr 28, 1983

HEPARIN SODIUM HEPARIN SODIUM LUITPOLD

INJECTABLE;INJE

CTION 1,000 UNITS/ML A087452 Oct 31, 1983

HEPARIN SODIUM HEPARIN SODIUM SMITH AND NEPHEW

INJECTABLE;INJE

CTION 1,000 UNITS/ML A088239 Jul 26, 1984

HEPARIN SODIUM HEPARIN SODIUM SOLOPAK

INJECTABLE;INJE

CTION

5,000 

UNITS/0.5ML A087395 Oct 07, 1981

HEPARIN SODIUM HEPARIN SODIUM SOLOPAK

INJECTABLE;INJE

CTION 5,000 UNITS/ML A087077 May 01, 1981

HEPARIN SODIUM HEPARIN SODIUM SOLOPAK

INJECTABLE;INJE

CTION 1,000 UNITS/ML A087043 May 01, 1981

HEPARIN SODIUM HEPARIN SODIUM SOLOPAK

INJECTABLE;INJE

CTION

10,000 

UNITS/0.5ML A087363 Oct 07, 1981

HEPARIN SODIUM HEPARIN SODIUM SOLOPAK

INJECTABLE;INJE

CTION

10,000 

UNITS/ML A087107 May 01, 1981

HEPARIN SODIUM

HEPARIN SODIUM PRESERVATIVE 

FREE PHARMA SERVE NY

INJECTABLE;INJE

CTION 1,000 UNITS/ML A086129 Feb 22, 1980

Current as of July 2021 Page 59 of 130
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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HOMATROPINE METHYLBROMIDE EQUIPIN MISSION PHARMA

TABLET, 

CHEWABLE;ORAL 3MG A086310 Apr 11, 1979

HOMATROPINE METHYLBROMIDE HOMAPIN-10 MISSION PHARMA TABLET;ORAL 10MG A086308 Apr 11, 1979

HOMATROPINE METHYLBROMIDE HOMAPIN-5 MISSION PHARMA TABLET;ORAL 5MG A086309 Apr 11, 1979

HYDRALAZINE HYDROCHLORIDE DRALZINE TEVA TABLET;ORAL 25MG A084301 Oct 15, 1975

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE IMPAX LABS TABLET;ORAL 25MG A084922 Sep 21, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE IMPAX LABS TABLET;ORAL 50MG A084923 Aug 03, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 100MG A084581 Sep 12, 1975

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 10MG A084443 Sep 08, 1975

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG A084437 Feb 19, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 50MG A084469 Jul 23, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 25MG A084106 Jul 15, 1977

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 50MG A084107 Aug 10, 1977

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 25MG A088177 Jul 29, 1983

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE PUREPAC PHARM TABLET;ORAL 50MG A088178 Aug 15, 1983

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE QUANTUM PHARMICS TABLET;ORAL 100MG A088686 May 01, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE QUANTUM PHARMICS TABLET;ORAL 10MG A088671 May 01, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE QUANTUM PHARMICS TABLET;ORAL 25MG A088657 Jun 15, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE QUANTUM PHARMICS TABLET;ORAL 50MG A088652 May 08, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE SMITH AND NEPHEW

INJECTABLE;INJE

CTION 20MG/ML A088518 Apr 20, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE SUPERPHARM TABLET;ORAL 10MG A088787 Aug 28, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE SUPERPHARM TABLET;ORAL 25MG A088788 Aug 28, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE SUPERPHARM TABLET;ORAL 50MG A088789 Aug 28, 1984

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET;ORAL 10MG A083241 Aug 05, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET;ORAL 25MG A083560 Aug 05, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET;ORAL 50MG A085088 Aug 18, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE UPSHER SMITH LABS TABLET;ORAL 50MG A083561 Aug 05, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE USL PHARMA TABLET;ORAL 25MG A087780 Mar 29, 1982

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE USL PHARMA TABLET;ORAL 50MG A087751 Mar 29, 1982

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE VANGARD TABLET;ORAL 25MG A087712 Dec 08, 1981

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE VANGARD TABLET;ORAL 50MG A087908 May 07, 1982

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE VITARINE TABLET;ORAL 25MG A086088 Oct 23, 1978

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A084504 Nov 23, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A085532 May 24, 1982

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A084503 Nov 23, 1976

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085533 May 25, 1982

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 25MG A088240 May 27, 1983

HYDRALAZINE HYDROCHLORIDE HYDRALAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 50MG A088241 May 27, 1983

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE APRESAZIDE NOVARTIS CAPSULE;ORAL 25MG;25MG A084735 May 26, 1976

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE APRESAZIDE NOVARTIS CAPSULE;ORAL 50MG;50MG A084810 May 26, 1976

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE APRESAZIDE NOVARTIS CAPSULE;ORAL 100MG;50MG A084811 May 26, 1976

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE AND 

HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 25MG;15MG A085827 Oct 21, 1977

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE 

AND HYDROCHLOROTHIAZIDE SOLVAY CAPSULE;ORAL 25MG;25MG A087608 Feb 08, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE 

AND HYDROCHLOROTHIAZIDE SOLVAY CAPSULE;ORAL 50MG;50MG A087213 Feb 08, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE 

AND HYDROCHLOROTHIAZIDE SOLVAY CAPSULE;ORAL 100MG;50MG A087609 Feb 08, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE 

AND HYDROCHLOROTHIAZIDE WATSON LABS CAPSULE;ORAL 25MG;25MG A085457 Mar 04, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE 

AND HYDROCHLOROTHIAZIDE WATSON LABS CAPSULE;ORAL 50MG;50MG A085446 Mar 04, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE 

AND HYDROCHLOROTHIAZIDE WATSON LABS CAPSULE;ORAL 100MG;50MG A085440 Mar 04, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE W/ 

HYDROCHLOROTHIAZIDE 100/50 IVAX PHARMS CAPSULE;ORAL 100MG;50MG A088358 Apr 10, 1984

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE W/ 

HYDROCHLOROTHIAZIDE 25/25 IVAX PHARMS CAPSULE;ORAL 25MG;25MG A088356 Apr 10, 1984

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDRALAZINE HYDROCHLORIDE W/ 

HYDROCHLOROTHIAZIDE 50/50 IVAX PHARMS CAPSULE;ORAL 50MG;50MG A088357 Apr 10, 1984

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE

HYDROCHLOROTHIAZIDE W/ 

HYDRALAZINE WATSON LABS TABLET;ORAL 25MG;15MG A085373 Feb 14, 1977

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE CAM-AP-ES CHARTWELL RX TABLET;ORAL

25MG;15MG;0.1M

G A084897 Nov 20, 1979

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDRALAZINE HYDROCHLORIDE, 

HYDROCHLOROTHIAZIDE AND 

RESERPINE IVAX SUB TEVA PHARMS TABLET;ORAL

25MG;15MG;0.1M

G A084291 Feb 03, 1975

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDRALAZINE HYDROCHLORIDEHYDROCHLOROTHIAZIDERESERPINE MYLAN TABLET;ORAL

25MG;15MG;0.1M

G A087085 May 29, 1981

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDRALAZINE, 

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL

25MG;15MG;0.1M

G A085771 Apr 21, 1978

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE HYDRAP-ES SANDOZ TABLET;ORAL

25MG;15MG;0.1M

G A084876 Sep 10, 1981

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE AND HYDRALAZINE WATSON LABS TABLET;ORAL

25MG;15MG;0.1M

G A083770 Oct 28, 1976

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE HYDROSERPINE PLUS (R-H-H) IVAX SUB TEVA PHARMS TABLET;ORAL

25MG;15MG;0.1M

G A083877 Sep 18, 1975

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE, HYDRALAZINE 

HYDROCHLORIDE AND 

HYDROCHLOROTHIAZIDE SOLVAY TABLET;ORAL

25MG;15MG;0.1M

G A088376 Oct 28, 1983

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE, HYDRALAZINE 

HYDROCHLORIDE AND 

HYDROCHLOROTHIAZIDE SUN PHARM INDUSTRIES TABLET;ORAL

25MG;15MG;0.1M

G A088570 Apr 10, 1984

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE, HYDRALAZINE 

HYDROCHLORIDE AND 

HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL

25MG;15MG;0.1M

G A085549 Sep 29, 1977

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE, HYDRALAZINE 

HYDROCHLORIDE AND 

HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL

25MG;15MG;0.1M

G A087556 Aug 06, 1981

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE, 

HYDROCHLOROTHIAZIDE, AND 

HYDRALAZINE HYDROCHLORIDE LEDERLE TABLET;ORAL

25MG;15MG;0.1M

G A087709 May 13, 1982

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE SER-A-GEN SOLVAY TABLET;ORAL

25MG;15MG;0.1M

G A087210 Feb 08, 1980

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE UNIPRES SOLVAY TABLET;ORAL

25MG;15MG;0.1M

G A085893 Feb 10, 1978

HYDRALAZINE HYDROCHLORIDE; 

HYDROCHLOROTHIAZIDE; 

RESERPINE UNIPRES SOLVAY TABLET;ORAL

25MG;15MG;0.1M

G A086298 Mar 27, 1978

HYDRALAZINE HYDROCHLORIDE; 

RESERPINE DRALSERP SANDOZ TABLET;ORAL 25MG;0.1MG A084617 Aug 13, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ABC HOLDING TABLET;ORAL 50MG A085672 Jun 02, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH TABLET;ORAL 25MG A085054 Aug 20, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ACTAVIS ELIZABETH TABLET;ORAL 50MG A085208 Aug 20, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ALRA TABLET;ORAL 25MG A086369 Nov 06, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ALRA TABLET;ORAL 50MG A083554 Nov 06, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ASCOT TABLET;ORAL 25MG A087539 Feb 03, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ASCOT TABLET;ORAL 50MG A087540 Feb 03, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE AUROLIFE PHARMA LLC TABLET;ORAL 25MG A083899 Sep 17, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE AUROLIFE PHARMA LLC TABLET;ORAL 50MG A085219 Mar 12, 1979

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE BARR TABLET;ORAL 50MG A084771 Apr 01, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE CHARTWELL RX TABLET;ORAL 25MG A085683 Aug 17, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE CHARTWELL RX TABLET;ORAL 50MG A083965 Mar 21, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE DAVA PHARMS INC TABLET;ORAL 100MG A087060 Nov 05, 1980

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ELKINS SINN TABLET;ORAL 50MG A085152 Feb 28, 1980

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HEATHER TABLET;ORAL 50MG A084135 Oct 25, 1974

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HIKMA INTL PHARMS TABLET;ORAL 50MG A084878 Jan 31, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IMPAX LABS TABLET;ORAL 100MG A085098 Jul 15, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IMPAX LABS TABLET;ORAL 25MG A084029 Jul 05, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IMPAX LABS TABLET;ORAL 50MG A083607 Jun 06, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE INWOOD LABS TABLET;ORAL 25MG A085067 Oct 05, 1976

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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE INWOOD LABS TABLET;ORAL 25MG A084776 Sep 21, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE INWOOD LABS TABLET;ORAL 50MG A084776 Sep 21, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS TABLET;ORAL 100MG A085022 Sep 01, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE IVAX SUB TEVA PHARMS TABLET;ORAL 50MG A084658 Sep 24, 1975

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE LANNETT CO INC TABLET;ORAL 25MG A084325 Jun 24, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE LANNETT CO INC TABLET;ORAL 50MG A084324 Jun 24, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MAST MM TABLET;ORAL 25MG A086192 Jul 13, 1979

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MAST MM TABLET;ORAL 50MG A086192 Jul 13, 1979

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MYLAN TABLET;ORAL 25MG A084880 Jan 12, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE MYLAN TABLET;ORAL 50MG A085112 May 23, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE PVT FORM TABLET;ORAL 50MG A086597 Oct 11, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ROXANE SOLUTION;ORAL 50MG/5ML A088587 Jul 02, 1984

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ROXANE TABLET;ORAL 25MG A085004 Jul 13, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ROXANE TABLET;ORAL 50MG A084536 May 22, 1975

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE ROXANE TABLET;ORAL 50MG A085005 Jul 13, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SOLVAY TABLET;ORAL 25MG A085323 Jun 01, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SUN PHARM INDUSTRIES TABLET;ORAL 100MG A083972 Aug 15, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SUN PHARM INDUSTRIES TABLET;ORAL 25MG A083972 Oct 03, 1974

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE SUN PHARM INDUSTRIES TABLET;ORAL 50MG A083972 Oct 03, 1974

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE USL PHARMA TABLET;ORAL 25MG A087827 Apr 19, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE USL PHARMA TABLET;ORAL 50MG A087752 Apr 19, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE VANGARD TABLET;ORAL 25MG A087638 Dec 07, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE VANGARD TABLET;ORAL 50MG A087610 Dec 07, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WARNER CHILCOTT TABLET;ORAL 25MG A087586 May 03, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WARNER CHILCOTT TABLET;ORAL 50MG A087587 May 03, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 100MG A087002 Feb 09, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 100MG A085099 Aug 31, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 25MG A085232 Nov 04, 1981

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 25MG A083458 Aug 31, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 50MG A086594 Oct 05, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 50MG A085233 Apr 27, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 50MG A083456 Jun 11, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 50MG A086087 Jul 17, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WATSON LABS TEVA TABLET;ORAL 50MG A083232 Jan 24, 1975

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WEST WARD TABLET;ORAL 25MG A084899 Jan 31, 1977

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WHITEWORTH TOWN PLSN TABLET;ORAL 100MG A085347 Jan 26, 1978

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WHITEWORTH TOWN PLSN TABLET;ORAL 25MG A083809 Jul 02, 1974

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE WHITEWORTH TOWN PLSN TABLET;ORAL 50MG A083809 Jul 02, 1974

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE YAOPHARMA CO LTD TABLET;ORAL 25MG A087565 Mar 09, 1982

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE YAOPHARMA CO LTD TABLET;ORAL 50MG A084912 Dec 17, 1976

HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE INTENSOL ROXANE SOLUTION;ORAL 100MG/ML A088588 Jul 02, 1984

HYDROCHLOROTHIAZIDE HYDRO-D HALSEY TABLET;ORAL 25MG A086504 Mar 21, 1979

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCHLOROTHIAZIDE HYDRO-D HALSEY TABLET;ORAL 50MG A083891 Oct 31, 1978

HYDROCHLOROTHIAZIDE ZIDE SOLVAY TABLET;ORAL 50MG A083925 May 03, 1977

HYDROCHLOROTHIAZIDE; 

RESERPINE H.R.-50 WHITEWORTH TOWN PLSN TABLET;ORAL 50MG;0.125MG A085338 Apr 10, 1978

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE IVAX SUB TEVA PHARMS TABLET;ORAL 50MG;0.125MG A083573 Dec 11, 1973

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE IVAX SUB TEVA PHARMS TABLET;ORAL 50MG;0.1MG A083568 Dec 04, 1973

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG;0.125MG A083571 Nov 20, 1973

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG;0.1MG A083572 Nov 26, 1973

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE PHARMERAL TABLET;ORAL 50MG;0.125MG A085420 Mar 10, 1977

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE PHARMERAL TABLET;ORAL 25MG;0.125MG A085421 Mar 17, 1977

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE ROXANE TABLET;ORAL 50MG;0.125MG A084603 May 20, 1975

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 50MG;0.125MG A083666 Oct 27, 1976

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 50MG;0.125MG A086331 Jun 12, 1978

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 25MG;0.125MG A084466 Jan 07, 1977

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 50MG;0.125MG A084467 Jan 07, 1977

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 25MG;0.125MG A085317 Nov 22, 1976

HYDROCHLOROTHIAZIDE; 

RESERPINE

HYDROCHLOROTHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 25MG;0.125MG A086330 May 19, 1981

HYDROCHLOROTHIAZIDE; 

RESERPINE HYDRO-RESERP ABC HOLDING TABLET;ORAL 50MG;0.125MG A084714 Jun 29, 1982

HYDROCHLOROTHIAZIDE; 

RESERPINE HYDRO-SERP "25" SANDOZ TABLET;ORAL 25MG;0.125MG A084827 Apr 16, 1981

HYDROCHLOROTHIAZIDE; 

RESERPINE HYDRO-SERP "50" SANDOZ TABLET;ORAL 50MG;0.125MG A085213 Apr 16, 1981

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE AND 

HYDROCHLOROTHIAZIDE BARR TABLET;ORAL 50MG;0.125MG A084579 Sep 30, 1975

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE AND 

HYDROCHLOROTHIAZIDE BARR TABLET;ORAL 25MG;0.125MG A084580 May 30, 1975

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE AND 

HYDROCHLOROTHIAZIDE SANDOZ TABLET;ORAL 50MG;0.125MG A088200 Jan 31, 1984

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCHLOROTHIAZIDE; 

RESERPINE

RESERPINE AND 

HYDROCHLOROTHIAZIDE-50 WEST WARD TABLET;ORAL 50MG;0.125MG A088189 May 10, 1984

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE AND 

HYDROCHLOROTHIAZIDE MUTUAL PHARM TABLET;ORAL 25MG;25MG A087267 Apr 16, 1981

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE AND 

HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 25MG;25MG A087398 Nov 24, 1981

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE AND 

HYDROCHLOROTHIAZIDE YAOPHARMA CO LTD TABLET;ORAL 25MG;25MG A086881 Jul 10, 1980

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE IVAX PHARMS TABLET;ORAL 25MG;25MG A087004 May 24, 1982

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE LEDERLE TABLET;ORAL 25MG;25MG A087511 Sep 02, 1981

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE PARKE DAVIS TABLET;ORAL 25MG;25MG A087948 Feb 22, 1983

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE PUREPAC PHARM TABLET;ORAL 25MG;25MG A088054 Aug 18, 1983

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE UPSHER SMITH TABLET;ORAL 25MG;25MG A087553 Nov 16, 1981

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE USL PHARMA TABLET;ORAL 25MG;25MG A087651 Oct 22, 1981

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE VANGARD TABLET;ORAL 25MG;25MG A087655 Dec 14, 1981

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 25MG;25MG A085974 Feb 27, 1979

HYDROCHLOROTHIAZIDE; 

SPIRONOLACTONE

SPIRONOLACTONE W/ 

HYDROCHLOROTHIAZIDE WATSON LABS TABLET;ORAL 25MG;25MG A086026 Apr 03, 1981

HYDROCORTISONE ACTICORT BAKER NORTON LOTION;TOPICAL 1% A086535 Feb 04, 1981

HYDROCORTISONE AEROSEB-HC ALLERGAN HERBERT AEROSOL;TOPICAL 0.5% A085805 Apr 24, 1979

HYDROCORTISONE ALA-CORT CROWN LABS LOTION;TOPICAL 1% A083201 Feb 28, 1973

HYDROCORTISONE BALNEOL-HC SOLVAY LOTION;TOPICAL 1% A088041 Dec 03, 1982

HYDROCORTISONE CETACORT BAUSCH LOTION;TOPICAL 0.5% A080426 Dec 22, 1971

HYDROCORTISONE CETACORT BAUSCH LOTION;TOPICAL 1% A080426 Dec 22, 1971

HYDROCORTISONE DERMACORT MONARCH PHARMS CREAM;TOPICAL 1% A083011 Apr 26, 1973

HYDROCORTISONE DERMACORT SOLVAY LOTION;TOPICAL 0.5% A084573 Jul 27, 1976

HYDROCORTISONE DERMACORT SOLVAY LOTION;TOPICAL 1% A086462 Aug 23, 1979

HYDROCORTISONE ELDECORT VALEANT PHARM INTL CREAM;TOPICAL 1% A080459 May 09, 1974

HYDROCORTISONE ELDECORT VALEANT PHARM INTL CREAM;TOPICAL 2.5% A084055 May 06, 1974

HYDROCORTISONE EPICORT BLULINE LOTION;TOPICAL 0.5% A083219 Mar 28, 1973

HYDROCORTISONE FLEXICORT WESTWOOD SQUIBB CREAM;TOPICAL 0.5% A087136 Apr 08, 1982

HYDROCORTISONE FLEXICORT WESTWOOD SQUIBB CREAM;TOPICAL 1% A087136 Apr 08, 1982

HYDROCORTISONE FLEXICORT WESTWOOD SQUIBB CREAM;TOPICAL 2.5% A087136 Apr 08, 1982

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCORTISONE GLYCORT HERAN LOTION;TOPICAL 1% A087489 Oct 03, 1983

HYDROCORTISONE HC #1 BAYER PHARMS CREAM;TOPICAL 0.5% A080438 Jul 08, 1975

HYDROCORTISONE HC #4 BAYER PHARMS CREAM;TOPICAL 1% A080438 Jul 08, 1975

HYDROCORTISONE HC (HYDROCORTISONE) C AND M PHARMA CREAM;TOPICAL 0.5% A080482 Mar 20, 1973

HYDROCORTISONE HC (HYDROCORTISONE) C AND M PHARMA CREAM;TOPICAL 1% A080482 Mar 20, 1973

HYDROCORTISONE HC (HYDROCORTISONE) C AND M PHARMA

OINTMENT;TOPICA

L 1% A080481 Mar 20, 1973

HYDROCORTISONE HC (HYDROCORTISONE) C AND M PHARMA

OINTMENT;TOPICA

L 0.5% A080481 Mar 20, 1973

HYDROCORTISONE H-CORT PHARM ASSOC CREAM;TOPICAL 0.5% A086823 Dec 11, 1979

HYDROCORTISONE H-CORT PHARM ASSOC LOTION;TOPICAL 0.5% A086824 Dec 11, 1979

HYDROCORTISONE H-CORT TORCH

POWDER;FOR RX 

COMPOUNDING 100% A087834 Mar 29, 1982

HYDROCORTISONE HI-COR C AND M PHARMA CREAM;TOPICAL 2.5% A080483 Mar 20, 1973

HYDROCORTISONE HYDROCORTISONE ACTAVIS MID ATLANTIC

OINTMENT;TOPICA

L 1% A087796 Oct 13, 1982

HYDROCORTISONE HYDROCORTISONE ALPHARMA US PHARMS LOTION;TOPICAL 0.5% A087317 Jun 07, 1982

HYDROCORTISONE HYDROCORTISONE ALPHARMA US PHARMS LOTION;TOPICAL 1% A087315 Jun 07, 1982

HYDROCORTISONE HYDROCORTISONE ALTANA CREAM;TOPICAL 0.5% A080848 Sep 06, 1972

HYDROCORTISONE HYDROCORTISONE ALTANA CREAM;TOPICAL 1% A080848 Sep 06, 1972

HYDROCORTISONE HYDROCORTISONE ALTANA

OINTMENT;TOPICA

L 1% A080489 Jun 30, 1972

HYDROCORTISONE HYDROCORTISONE ALTANA

OINTMENT;TOPICA

L 0.5% A080489 Jun 30, 1972

HYDROCORTISONE HYDROCORTISONE AMBIX CREAM;TOPICAL 1% A086080 Apr 26, 1978

HYDROCORTISONE HYDROCORTISONE AMBIX CREAM;TOPICAL 2.5% A086271 Apr 26, 1978

HYDROCORTISONE HYDROCORTISONE AMBIX

OINTMENT;TOPICA

L 1% A086079 May 11, 1978

HYDROCORTISONE HYDROCORTISONE AMBIX

OINTMENT;TOPICA

L 2.5% A086272 Apr 26, 1978

HYDROCORTISONE HYDROCORTISONE BARR TABLET;ORAL 20MG A083999 Mar 06, 1974

HYDROCORTISONE HYDROCORTISONE ELKINS SINN TABLET;ORAL 20MG A080624 Mar 24, 1972

HYDROCORTISONE HYDROCORTISONE EVERYLIFE CREAM;TOPICAL 0.5% A080452 Dec 29, 1971

HYDROCORTISONE HYDROCORTISONE EVERYLIFE CREAM;TOPICAL 1% A080452 Dec 29, 1971

HYDROCORTISONE HYDROCORTISONE FERRANTE TABLET;ORAL 10MG A080568 May 01, 1972

HYDROCORTISONE HYDROCORTISONE FERRANTE TABLET;ORAL 20MG A080568 May 01, 1972

HYDROCORTISONE HYDROCORTISONE G AND W LABS CREAM;TOPICAL 1% A084059 Oct 28, 1977

HYDROCORTISONE HYDROCORTISONE HIKMA INTL PHARMS TABLET;ORAL 20MG A083365 Jun 18, 1973

HYDROCORTISONE HYDROCORTISONE IMPAX LABS TABLET;ORAL 20MG A080781 Aug 02, 1973

HYDROCORTISONE HYDROCORTISONE INGRAM PHARM CREAM;TOPICAL 0.5% A080456 Jan 06, 1976

HYDROCORTISONE HYDROCORTISONE INGRAM PHARM CREAM;TOPICAL 1% A080456 Jan 06, 1976

HYDROCORTISONE HYDROCORTISONE INWOOD LABS TABLET;ORAL 20MG A080732 Jul 27, 1972

HYDROCORTISONE HYDROCORTISONE IVAX PHARMS CREAM;TOPICAL 1% A085733 Nov 06, 1978

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCORTISONE HYDROCORTISONE LANNETT TABLET;ORAL 20MG A085070 May 07, 1976

HYDROCORTISONE HYDROCORTISONE MERICON LOTION;TOPICAL 0.5% A085282 Jun 05, 1978

HYDROCORTISONE HYDROCORTISONE NEXGEN PHARMA INC TABLET;ORAL 20MG A083140 Mar 09, 1973

HYDROCORTISONE HYDROCORTISONE PADDOCK LLC

POWDER;FOR RX 

COMPOUNDING 100% A088082 Apr 08, 1983

HYDROCORTISONE HYDROCORTISONE PARKE DAVIS TABLET;ORAL 20MG A084243 May 30, 1975

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK CREAM;TOPICAL 0.5% A084970 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK CREAM;TOPICAL 1% A085026 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK LOTION;TOPICAL 0.5% A085662 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK LOTION;TOPICAL 1% A085663 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK

OINTMENT;TOPICA

L 1% A085028 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PERRIGO NEW YORK

OINTMENT;TOPICA

L 0.5% A084969 Nov 30, 1977

HYDROCORTISONE HYDROCORTISONE PHARMAFAIR CREAM;TOPICAL 1% A087838 Jul 28, 1982

HYDROCORTISONE HYDROCORTISONE PUREPAC PHARM TABLET;ORAL 10MG A084247 Aug 31, 1982

HYDROCORTISONE HYDROCORTISONE PUREPAC PHARM TABLET;ORAL 20MG A080395 Apr 28, 1972

HYDROCORTISONE HYDROCORTISONE PUREPAC PHARM TABLET;ORAL 20MG A084247 May 15, 1975

HYDROCORTISONE HYDROCORTISONE ROXANE TABLET;ORAL 10MG A088539 Mar 21, 1984

HYDROCORTISONE HYDROCORTISONE SANDOZ TABLET;ORAL 20MG A080642 May 31, 1974

HYDROCORTISONE HYDROCORTISONE STIEFEL CREAM;TOPICAL 1% A086170 Nov 02, 1978

HYDROCORTISONE HYDROCORTISONE SYOSSET CREAM;TOPICAL 0.5% A085527 Dec 07, 1978

HYDROCORTISONE HYDROCORTISONE TARO CREAM;TOPICAL 0.5% A086154 Jul 24, 1978

HYDROCORTISONE HYDROCORTISONE TARO

OINTMENT;TOPICA

L 0.5% A086256 Jul 24, 1978

HYDROCORTISONE HYDROCORTISONE TARO PHARM INDS LTD CREAM;TOPICAL 1% A086155 Jul 24, 1978

HYDROCORTISONE HYDROCORTISONE TEVA CREAM;TOPICAL 0.5% A080400 Sep 15, 1972

HYDROCORTISONE HYDROCORTISONE TEVA CREAM;TOPICAL 1% A085191 Jan 23, 1978

HYDROCORTISONE HYDROCORTISONE TEVA CREAM;TOPICAL 1% A080400 Sep 15, 1972

HYDROCORTISONE HYDROCORTISONE TEVA CREAM;TOPICAL 2.5% A080400 Sep 15, 1972

HYDROCORTISONE HYDROCORTISONE USL PHARMA CREAM;TOPICAL 1% A088027 Sep 27, 1983

HYDROCORTISONE HYDROCORTISONE USL PHARMA CREAM;TOPICAL 2.5% A088029 Sep 27, 1983

HYDROCORTISONE HYDROCORTISONE USL PHARMA

OINTMENT;TOPICA

L 1% A088061 Sep 27, 1983

HYDROCORTISONE HYDROCORTISONE USL PHARMA

OINTMENT;TOPICA

L 2.5% A088039 Sep 27, 1983

HYDROCORTISONE HYDROCORTISONE WATSON LABS TABLET;ORAL 20MG A080355 Jun 15, 1972

HYDROCORTISONE HYDROCORTISONE WHITEWORTH TOWN PLSN CREAM;TOPICAL 1% A080496 May 18, 1973

HYDROCORTISONE HYDROCORTISONE WHITEWORTH TOWN PLSN TABLET;ORAL 10MG A080344 Jul 18, 1973

HYDROCORTISONE HYDROCORTISONE WHITEWORTH TOWN PLSN TABLET;ORAL 20MG A080344 Jul 18, 1973

HYDROCORTISONE HYDRO-RX X GEN PHARMS

POWDER;FOR RX 

COMPOUNDING 100% A085982 May 09, 1978

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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCORTISONE HYTONE DERMIK LABS

OINTMENT;TOPICA

L 1% A080474 Sep 26, 1972

HYDROCORTISONE HYTONE DERMIK LABS

OINTMENT;TOPICA

L 2.5% A080474 Sep 26, 1972

HYDROCORTISONE HYTONE VALEANT INTL CREAM;TOPICAL 1% A080472 Sep 27, 1972

HYDROCORTISONE HYTONE VALEANT INTL CREAM;TOPICAL 2.5% A080472 Sep 27, 1972

HYDROCORTISONE HYTONE VALEANT INTL LOTION;TOPICAL 1% A080473 Sep 25, 1972

HYDROCORTISONE HYTONE VALEANT INTL LOTION;TOPICAL 2.5% A080473 Nov 30, 1982

HYDROCORTISONE NUTRACORT BAUSCH CREAM;TOPICAL 0.5% A080442 Apr 04, 1972

HYDROCORTISONE NUTRACORT BAUSCH CREAM;TOPICAL 1% A080442 Apr 04, 1972

HYDROCORTISONE NUTRACORT DOW PHARM LOTION;TOPICAL 0.5% A080443 Apr 26, 1972

HYDROCORTISONE NUTRACORT DOW PHARM LOTION;TOPICAL 1% A080443 Apr 26, 1972

HYDROCORTISONE NUTRACORT DOW PHARM LOTION;TOPICAL 2.5% A087644 Aug 24, 1982

HYDROCORTISONE NUTRACORT HEALTHPOINT GEL;TOPICAL 1% A084698 Jan 06, 1976

HYDROCORTISONE PENECORT ALLERGAN HERBERT CREAM;TOPICAL 1% A088216 Jun 06, 1984

HYDROCORTISONE PENECORT ALLERGAN HERBERT GEL;TOPICAL 1% A088215 Jun 06, 1984

HYDROCORTISONE PENECORT ALLERGAN HERBERT

OINTMENT;TOPICA

L 2.5% A088217 Jun 06, 1984

HYDROCORTISONE PENECORT ALLERGAN HERBERT

SOLUTION;TOPICA

L 1% A088214 Jun 06, 1984

HYDROCORTISONE PROCTOCORT MONARCH PHARMS CREAM;TOPICAL 1% A083011 Apr 26, 1973

HYDROCORTISONE SYNACORT BAUSCH CREAM;TOPICAL 0.5% A087459 Jun 23, 1981

HYDROCORTISONE SYNACORT BAUSCH CREAM;TOPICAL 1% A087458 Jun 23, 1981

HYDROCORTISONE SYNACORT BAUSCH CREAM;TOPICAL 2.5% A087457 Jun 23, 1981

HYDROCORTISONE TEXACORT MISSION PHARMA

SOLUTION;TOPICA

L 1% A080425 Dec 22, 1971

HYDROCORTISONE ACETATE CARMOL HC FOUGERA PHARMS CREAM;TOPICAL 1% A080505 Jan 12, 1973

HYDROCORTISONE ACETATE DRICORT INGRAM PHARM LOTION;TOPICAL 0.5% A086207 Oct 16, 1978

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE BEL MAR

INJECTABLE;INJE

CTION 25MG/ML A083739 Jan 21, 1974

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE BEL MAR

INJECTABLE;INJE

CTION 50MG/ML A083739 Jan 21, 1974

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE CENCI CREAM;TOPICAL 1% A080419 Jan 25, 1982

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE FERA PHARMS

OINTMENT;OPHTHA

LMIC 0.5% A080828 May 13, 1976

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE PUREPAC PHARM CREAM;TOPICAL 0.5% A086050 Feb 08, 1979

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE PUREPAC PHARM CREAM;TOPICAL 1% A086052 Feb 08, 1979

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A083128 Feb 27, 1979

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A083759 Mar 07, 1978

Current as of July 2021 Page 69 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A085214 May 05, 1978

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A083759 May 07, 1978

HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE X GEN PHARMS

POWDER;FOR RX 

COMPOUNDING 100% A085981 May 09, 1978

HYDROCORTISONE ACETATE ORABASE HCA COLGATE PASTE;TOPICAL 0.5% A083205 Mar 06, 1973

HYDROCORTISONE ACETATE; 

PRAMOXINE HYDROCHLORIDE PRAMOSONE FERNDALE LABS LOTION;TOPICAL 0.5%;1% A083213 Aug 19, 1978

HYDROCORTISONE SODIUM 

SUCCINATE A-HYDROCORT ABBOTT

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A085928 Mar 28, 1978

HYDROCORTISONE SODIUM 

SUCCINATE A-HYDROCORT HOSPIRA

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A085929 Mar 28, 1978

HYDROCORTISONE SODIUM 

SUCCINATE A-HYDROCORT HOSPIRA

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A085932 Mar 31, 1978

HYDROCORTISONE SODIUM 

SUCCINATE A-HYDROCORT HOSPIRA

INJECTABLE;INJE

CTION

EQ 250MG 

BASE/VIAL A085930 Mar 28, 1978

HYDROCORTISONE SODIUM 

SUCCINATE A-HYDROCORT HOSPIRA

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A085931 Mar 28, 1978

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A088667 Jun 08, 1984

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A088712 Jun 08, 1984

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A088670 Jun 08, 1984

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 250MG 

BASE/VIAL A088668 Jun 08, 1984

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A088669 Jun 08, 1984

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE BAXTER HLTHCARE

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A086619 May 28, 1981

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE BAXTER HLTHCARE

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A087569 May 28, 1981

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE BAXTER HLTHCARE

INJECTABLE;INJE

CTION

EQ 250MG 

BASE/VIAL A087567 May 28, 1981

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE BAXTER HLTHCARE

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A087568 May 28, 1981

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE INTL MEDICATION

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A087532 Mar 19, 1982

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A084738 Dec 10, 1980

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A084737 Dec 17, 1980

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A084748 Sep 16, 1981

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 250MG 

BASE/VIAL A084737 Dec 17, 1980

HYDROCORTISONE SODIUM 

SUCCINATE

HYDROCORTISONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A084747 Sep 16, 1981

HYDROCORTISONE; UREA ALPHADERM BIOGLAN CREAM;TOPICAL 1%;10% A086008 Jan 20, 1978

HYDROCORTISONE; UREA CALMURID HC PHARMACIA AND UPJOHN CREAM;TOPICAL 1%;10% A083947 Jun 09, 1978

HYDROFLUMETHIAZIDE DIUCARDIN WYETH AYERST TABLET;ORAL 50MG A083383 Dec 20, 1973

HYDROFLUMETHIAZIDE HYDROFLUMETHIAZIDE WATSON LABS TABLET;ORAL 50MG A088031 Apr 06, 1983

HYDROFLUMETHIAZIDE HYDROFLUMETHIAZIDE WATSON LABS TABLET;ORAL 50MG A088528 Aug 15, 1984

HYDROFLUMETHIAZIDE; 

RESERPINE

HYDROFLUMETHIAZIDE AND 

RESERPINE USL PHARMA TABLET;ORAL 50MG;0.125MG A088195 Oct 26, 1983

HYDROFLUMETHIAZIDE; 

RESERPINE

HYDROFLUMETHIAZIDE AND 

RESERPINE WATSON LABS TABLET;ORAL 25MG;0.125MG A088127 Mar 22, 1983

HYDROFLUMETHIAZIDE; 

RESERPINE

HYDROFLUMETHIAZIDE AND 

RESERPINE WATSON LABS TABLET;ORAL 50MG;0.125MG A088110 Mar 22, 1983

HYDROXOCOBALAMIN ALPHAREDISOL MERCK

INJECTABLE;INJE

CTION 1MG/ML A080778 Apr 18, 1975

HYDROXOCOBALAMIN HYDROXOCOBALAMIN ABRAXIS PHARM

INJECTABLE;INJE

CTION 1MG/ML A084921 Sep 12, 1979

HYDROXOCOBALAMIN HYDROXOCOBALAMIN WATSON LABS

INJECTABLE;INJE

CTION 1MG/ML A085528 Jul 05, 1977

HYDROXOCOBALAMIN HYDROXOMIN BEL MAR

INJECTABLE;INJE

CTION 1MG/ML A084629 May 01, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 50MG/ML A085551 Aug 24, 1979

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE ALTANA

INJECTABLE;INJE

CTION 25MG/ML A087273 Apr 20, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE ALTANA

INJECTABLE;INJE

CTION 50MG/ML A087273 Apr 20, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE ANIMA SYRUP;ORAL 10MG/5ML A086880 Jul 17, 1980

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE AUROBINDO PHARMA LTD TABLET;ORAL 10MG A087871 Dec 20, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE AUROBINDO PHARMA LTD TABLET;ORAL 25MG A087871 Dec 20, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE AUROBINDO PHARMA LTD TABLET;ORAL 50MG A087871 Dec 20, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 25MG/ML A085551 Aug 24, 1979

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 50MG/ML A085779 Oct 05, 1979

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE;INJE

CTION 25MG/ML A088184 Mar 31, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE;INJE

CTION 25MG/ML A087329 Aug 11, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE;INJE

CTION 50MG/ML A088185 Mar 31, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE FRESENIUS KABI USA

INJECTABLE;INJE

CTION 50MG/ML A087329 Aug 11, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 25MG/ML A087416 Jun 15, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 50MG/ML A087546 Jun 15, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 50MG/ML A086821 Sep 05, 1979

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE IVAX PHARMS TABLET;ORAL 10MG A087216 Apr 03, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE IVAX PHARMS TABLET;ORAL 25MG A087410 Apr 03, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE IVAX PHARMS TABLET;ORAL 50MG A087411 Apr 03, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE KV PHARM SYRUP;ORAL 10MG/5ML A087730 Jul 01, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 100MG A087822 Jun 23, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 10MG A087819 Jun 23, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 25MG A087820 Jun 23, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 50MG A087821 Jun 23, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 10MG A088409 Nov 15, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 25MG A087857 Apr 18, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 50MG A087860 Apr 18, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 10MG A087246 Jul 14, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 25MG A085247 Mar 20, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SANDOZ TABLET;ORAL 50MG A087245 Mar 20, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SMITH AND NEPHEW

INJECTABLE;INJE

CTION 25MG/ML A087592 Nov 17, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SOLOPAK

INJECTABLE;INJE

CTION 25MG/ML A086822 Jan 22, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SOLOPAK

INJECTABLE;INJE

CTION 25MG/ML A087591 Nov 17, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SOLOPAK

INJECTABLE;INJE

CTION 50MG/ML A087310 Jan 22, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SOLOPAK

INJECTABLE;INJE

CTION 50MG/ML A087593 Nov 17, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SOLOPAK

INJECTABLE;INJE

CTION 50MG/ML A087595 Nov 17, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SOLOPAK

INJECTABLE;INJE

CTION 50MG/ML A087596 Nov 17, 1981

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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 100MG A087862 Apr 18, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE VINTAGE TABLET;ORAL 10MG A087602 Jan 22, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE VINTAGE TABLET;ORAL 25MG A087603 Jan 22, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE VINTAGE TABLET;ORAL 50MG A087604 Jan 22, 1982

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A085778 Oct 05, 1979

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A087274 Jul 28, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A087274 Jul 28, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A086827 Mar 20, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A088348 Sep 15, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A086829 Mar 20, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A088349 Sep 15, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A086836 May 18, 1981

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A088350 Sep 15, 1983

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 25MG/ML A086258 Jan 25, 1980

HYDROXYZINE HYDROCHLORIDE HYDROXYZINE HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 50MG/ML A086258 Jan 25, 1980

HYDROXYZINE HYDROCHLORIDE ORGATRAX ORGANON USA INC

INJECTABLE;INJE

CTION 25MG/ML A087014 Jun 27, 1980

HYDROXYZINE HYDROCHLORIDE ORGATRAX ORGANON USA INC

INJECTABLE;INJE

CTION 50MG/ML A087014 Jun 27, 1980

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE DURAMED PHARMS BARR CAPSULE;ORAL

EQ 100MG 

HYDROCHLORIDE A088595 Feb 29, 1984

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE DURAMED PHARMS BARR CAPSULE;ORAL

EQ 25MG 

HYDROCHLORIDE A088593 Feb 29, 1984

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE DURAMED PHARMS BARR CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A088594 Feb 29, 1984

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE IVAX SUB TEVA PHARMS CAPSULE;ORAL

EQ 25MG 

HYDROCHLORIDE A087761 Mar 05, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE IVAX SUB TEVA PHARMS CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A087760 Mar 05, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE PAR PHARM CAPSULE;ORAL

EQ 100MG 

HYDROCHLORIDE A087658 Jun 11, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE PAR PHARM CAPSULE;ORAL

EQ 25MG 

HYDROCHLORIDE A087656 Jun 11, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE PAR PHARM CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A087657 Jun 11, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE VANGARD CAPSULE;ORAL

EQ 25MG 

HYDROCHLORIDE A088392 Sep 19, 1983

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE VANGARD CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A088393 Sep 19, 1983

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 100MG 

HYDROCHLORIDE A086728 Oct 05, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 100MG 

HYDROCHLORIDE A087790 Aug 16, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 100MG 

HYDROCHLORIDE A086697 Aug 04, 1981

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 25MG 

HYDROCHLORIDE A086840 Jul 01, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 25MG 

HYDROCHLORIDE A086698 Aug 06, 1981

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A086705 Jul 01, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A087767 Aug 16, 1982

HYDROXYZINE PAMOATE HYDROXYZINE PAMOATE WATSON LABS CAPSULE;ORAL

EQ 50MG 

HYDROCHLORIDE A086695 Aug 06, 1981

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE LEDERLE TABLET;ORAL 10MG A086269 Feb 23, 1978

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE LEDERLE TABLET;ORAL 25MG A086267 Feb 23, 1978

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE LEDERLE TABLET;ORAL 50MG A086268 Feb 23, 1978

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE NOVARTIS

CONCENTRATE;ORA

L 25MG/ML A086765 Dec 10, 1981

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE ROXANE TABLET;ORAL 10MG A083799 Aug 05, 1977

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE ROXANE TABLET;ORAL 25MG A083799 Aug 05, 1977

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE ROXANE TABLET;ORAL 50MG A083799 Aug 05, 1977

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SANDOZ TABLET;ORAL 10MG A085200 Mar 13, 1981

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SANDOZ TABLET;ORAL 25MG A084869 Sep 03, 1976

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE SANDOZ TABLET;ORAL 50MG A085133 Mar 13, 1981

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TEVA TABLET;ORAL 10MG A083729 Jun 27, 1974

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TEVA TABLET;ORAL 25MG A083729 Aug 01, 1977

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE TEVA TABLET;ORAL 50MG A083729 Jun 27, 1974

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE USL PHARMA TABLET;ORAL 25MG A087776 Feb 10, 1982

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE VANGARD TABLET;ORAL 10MG A088036 Nov 03, 1982

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE VANGARD TABLET;ORAL 25MG A087619 Feb 09, 1982

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE VANGARD TABLET;ORAL 50MG A087631 Jan 04, 1982

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A085875 Feb 04, 1981

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A085220 Jul 19, 1976

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A085878 Oct 16, 1978

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A084252 Jun 24, 1976

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085877 Oct 30, 1978

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085221 Jul 19, 1976

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WEST WARD TABLET;ORAL 25MG A088222 May 26, 1983

IMIPRAMINE HYDROCHLORIDE IMIPRAMINE HYDROCHLORIDE WEST WARD TABLET;ORAL 50MG A088223 May 26, 1983

IMIPRAMINE HYDROCHLORIDE PRAMINE ALRA TABLET;ORAL 10MG A083827 Jun 19, 1978

IMIPRAMINE HYDROCHLORIDE PRAMINE ALRA TABLET;ORAL 25MG A083827 Jun 19, 1978

IMIPRAMINE HYDROCHLORIDE PRAMINE ALRA TABLET;ORAL 50MG A083827 Jun 19, 1978

IPODATE SODIUM BILIVIST BAYER HLTHCARE CAPSULE;ORAL 500MG A087768 Aug 11, 1982

ISOETHARINE HYDROCHLORIDE BETA-2 NEPHRON

SOLUTION;INHALA

TION 1% A086711 Mar 30, 1981

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ALPHARMA US PHARMS

SOLUTION;INHALA

TION 1% A087101 Jun 30, 1981

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ASTRAZENECA

SOLUTION;INHALA

TION 0.125% A087938 Nov 15, 1982

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ASTRAZENECA

SOLUTION;INHALA

TION 0.167% A088470 Mar 14, 1984

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ASTRAZENECA

SOLUTION;INHALA

TION 0.2% A088471 Mar 14, 1984

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ASTRAZENECA

SOLUTION;INHALA

TION 0.25% A088472 Mar 14, 1984

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ASTRAZENECA

SOLUTION;INHALA

TION 0.062% A087937 Nov 15, 1982

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE BAXTER HLTHCARE

SOLUTION;INHALA

TION 0.14% A088145 Mar 26, 1984

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE BAXTER HLTHCARE

SOLUTION;INHALA

TION 0.25% A088146 Aug 01, 1983

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE BAXTER HLTHCARE

SOLUTION;INHALA

TION 0.08% A088144 Jul 29, 1983

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE DEY

SOLUTION;INHALA

TION 1% A086763 Oct 22, 1979

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE DEY

SOLUTION;INHALA

TION 0.17% A087390 Apr 28, 1981

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE DEY

SOLUTION;INHALA

TION 0.25% A088188 Dec 03, 1982

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE DEY

SOLUTION;INHALA

TION 0.08% A088187 Dec 03, 1982

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE DEY

SOLUTION;INHALA

TION 0.1% A087389 Apr 28, 1981

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 1% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.143% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.167% A086651 Jun 23, 1980

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.2% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.25% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.077% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.08% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE INTL MEDICATION

SOLUTION;INHALA

TION 0.1% A086651 Jun 23, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE PARKE DAVIS

SOLUTION;INHALA

TION 1% A085889 Sep 15, 1978

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE PARKE DAVIS

SOLUTION;INHALA

TION 0.5% A085997 Sep 15, 1978

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ROXANE

SOLUTION;INHALA

TION 1% A086899 Oct 23, 1979

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ROXANE

SOLUTION;INHALA

TION 0.125% A087025 Feb 22, 1980

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ROXANE

SOLUTION;INHALA

TION 0.167% A088226 Sep 16, 1983

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ROXANE

SOLUTION;INHALA

TION 0.2% A087324 Apr 08, 1981

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ROXANE

SOLUTION;INHALA

TION 0.25% A088275 Jun 03, 1983

ISOETHARINE HYDROCHLORIDE ISOETHARINE HYDROCHLORIDE ROXANE

SOLUTION;INHALA

TION 0.1% A087396 Apr 08, 1981

ISOETHARINE MESYLATE ISOETHARINE MESYLATE ALPHARMA US PHARMS

AEROSOL, 

METERED;INHALAT

ION 0.34MG/INH A087858 Aug 21, 1984

ISONIAZID DOW-ISONIAZID DOW PHARM TABLET;ORAL 300MG A080330 Nov 04, 1971

ISONIAZID HYZYD MEDPOINTE PHARM HLC TABLET;ORAL 100MG A080134 Aug 26, 1974

ISONIAZID HYZYD MEDPOINTE PHARM HLC TABLET;ORAL 300MG A080134 Aug 26, 1974

ISONIAZID INH NOVARTIS TABLET;ORAL 300MG A080935 Mar 14, 1972

ISONIAZID ISONIAZID DURAMED PHARMS BARR TABLET;ORAL 100MG A088231 Mar 17, 1983

ISONIAZID ISONIAZID DURAMED PHARMS BARR TABLET;ORAL 300MG A088119 Mar 17, 1983

ISONIAZID ISONIAZID HALSEY TABLET;ORAL 50MG A083632 May 11, 1976

ISONIAZID ISONIAZID HIKMA INTL PHARMS TABLET;ORAL 100MG A080212 Feb 28, 1972

ISONIAZID ISONIAZID HIKMA INTL PHARMS TABLET;ORAL 300MG A087425 Jul 14, 1981

ISONIAZID ISONIAZID IMPAX LABS TABLET;ORAL 100MG A080153 Aug 01, 1973

ISONIAZID ISONIAZID IVAX SUB TEVA PHARMS TABLET;ORAL 100MG A080270 Feb 11, 1972

ISONIAZID ISONIAZID IVAX SUB TEVA PHARMS TABLET;ORAL 300MG A083610 Jan 15, 1974

ISONIAZID ISONIAZID MK LABS TABLET;ORAL 100MG A080941 Mar 16, 1972

Current as of July 2021 Page 76 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ISONIAZID ISONIAZID NEXGEN PHARMA INC TABLET;ORAL 100MG A084050 Oct 22, 1974

ISONIAZID ISONIAZID PERRIGO TABLET;ORAL 100MG A083060 Aug 16, 1974

ISONIAZID ISONIAZID PHARMAVITE TABLET;ORAL 100MG A085091 Jul 29, 1976

ISONIAZID ISONIAZID PHOENIX LABS NY TABLET;ORAL 100MG A080368 Dec 18, 1975

ISONIAZID ISONIAZID PHOENIX LABS NY TABLET;ORAL 50MG A080368 Dec 18, 1975

ISONIAZID ISONIAZID PUREPAC PHARM TABLET;ORAL 100MG A080132 Jul 14, 1982

ISONIAZID ISONIAZID PUREPAC PHARM TABLET;ORAL 50MG A080132 Jul 14, 1982

ISONIAZID ISONIAZID SUN PHARM INDUSTRIES TABLET;ORAL 100MG A080136 Nov 13, 1970

ISONIAZID ISONIAZID SUN PHARM INDUSTRIES TABLET;ORAL 300MG A083633 May 11, 1976

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 100MG A080401 Nov 04, 1971

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 100MG A080523 Feb 03, 1972

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 100MG A085790 Sep 09, 1977

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 300MG A083178 Jan 26, 1973

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 300MG A080521 Feb 28, 1972

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 300MG A085784 Sep 09, 1977

ISONIAZID ISONIAZID WATSON LABS TABLET;ORAL 50MG A080522 Feb 28, 1972

ISONIAZID ISONIAZID WHITEWORTH TOWN PLSN TABLET;ORAL 100MG A080120 Mar 14, 1971

ISONIAZID LANIAZID LANNETT TABLET;ORAL 100MG A080140 Aug 29, 1975

ISONIAZID LANIAZID LANNETT TABLET;ORAL 50MG A080140 Aug 29, 1975

ISONIAZID STANOZIDE EVERYLIFE TABLET;ORAL 100MG A080126 Jan 21, 1972

ISONIAZID STANOZIDE EVERYLIFE TABLET;ORAL 300MG A080126 Jan 21, 1972

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 0.2MG/ML A083431 Feb 25, 1975

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE ALPHARMA US PHARMS

AEROSOL, 

METERED;INHALAT

ION 0.12MG/INH A085904 Jun 12, 1979

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE ARMOUR PHARM

SOLUTION;INHALA

TION 0.031% A087935 Nov 18, 1982

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE ARMOUR PHARM

SOLUTION;INHALA

TION 0.062% A087936 Nov 18, 1982

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 0.2MG/ML A083486 Nov 15, 1974

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE DEY

SOLUTION;INHALA

TION 0.5% A086764 Jan 04, 1982

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 0.2MG/ML A083346 Jul 15, 1975

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 0.02MG/ML A083283 Nov 15, 1974

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE INTL MEDICATION

INJECTABLE;INJE

CTION 0.2MG/ML A083724 Jan 06, 1976

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE PARKE DAVIS

SOLUTION;INHALA

TION 0.25% A085994 Feb 21, 1978

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE PARKE DAVIS

SOLUTION;INHALA

TION 0.5% A085540 Jul 20, 1977

LEUCOVORIN CALCIUM WELLCOVORIN GLAXOSMITHKLINE

INJECTABLE;INJE

CTION EQ 5MG BASE/ML A087439 Oct 19, 1982

LEVONORDEFRIN; MEPIVACAINE 

HYDROCHLORIDE

ARESTOCAINE HYDROCHLORIDE W/ 

LEVONORDEFRIN SOLVAY

INJECTABLE;INJE

CTION 0.05MG/ML;2% A085010 Apr 15, 1976

LEVONORDEFRIN; MEPIVACAINE 

HYDROCHLORIDE

ISOCAINE HYDROCHLORIDE W/ 

LEVONORDEFRIN SEPTODONT INC

INJECTABLE;INJE

CTION 0.05MG/ML;2% A084697 Feb 06, 1976

LEVONORDEFRIN; MEPIVACAINE 

HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE W/ 

LEVONORDEFRIN BELMORA LLC

INJECTABLE;INJE

CTION 0.05MG/ML;2% A084850 Oct 21, 1983

LIDOCAINE ALPHACAINE CARLISLE

OINTMENT;TOPICA

L 5% A084944 Jan 18, 1977

LIDOCAINE ALPHACAINE CARLISLE

OINTMENT;TOPICA

L 5% A084946 Jun 03, 1977

LIDOCAINE ALPHACAINE CARLISLE

OINTMENT;TOPICA

L 5% A084947 Jun 03, 1977

LIDOCAINE LIDOCAINE BELMORA LLC

OINTMENT;TOPICA

L 5% A080210 Jun 30, 1971

LIDOCAINE HYDROCHLORIDE ALPHACAINE HYDROCHLORIDE CARLISLE

INJECTABLE;INJE

CTION 2% A084721 Oct 07, 1975

LIDOCAINE HYDROCHLORIDE ANESTACON BIONPHARMA INC JELLY;TOPICAL 2% A080429 Apr 11, 1974

LIDOCAINE HYDROCHLORIDE

LARYNGOTRACHEAL ANESTHESIA 

KIT KENDALL IL

SOLUTION;TOPICA

L 4% A087931 Jun 10, 1983

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 10% A087980 Feb 02, 1983

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 1% A086761 Dec 14, 1979

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 1% A080420 Feb 15, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 1.5% A080420 Feb 15, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2% A086761 Dec 14, 1979

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2% A080420 Feb 15, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2% A080420 Feb 15, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AKORN

INJECTABLE;INJE

CTION 1% A085037 Jul 29, 1976

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AKORN

INJECTABLE;INJE

CTION 2% A085037 Jul 29, 1976

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE AM REGENT

INJECTABLE;INJE

CTION 1% A080850 Jun 23, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 1% A080710 Dec 11, 1973

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 2% A080760 Dec 11, 1973

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE BELMORA LLC

INJECTABLE;INJE

CTION 2% A080504 Feb 23, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE DELL LABS

INJECTABLE;INJE

CTION 1% A083387 Mar 18, 1975

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE DELL LABS

INJECTABLE;INJE

CTION 2% A083388 Mar 18, 1975

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ELKINS SINN

INJECTABLE;INJE

CTION 0.5% A085131 Oct 29, 1976

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE ELKINS SINN

INJECTABLE;INJE

CTION 4% A084626 Apr 30, 1975

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 1% A083135 Jan 30, 1979

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 2% A083135 Jan 29, 1979

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 1.5% A088330 May 17, 1984

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 2% A088331 May 17, 1984

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 20% A083158 Feb 11, 1977

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 2% A083198 Dec 27, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LYPHOMED

INJECTABLE;INJE

CTION 1% A080390 Mar 14, 1977

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LYPHOMED

INJECTABLE;INJE

CTION 2% A080390 Mar 14, 1977

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE MILES

INJECTABLE;INJE

CTION 1% A080414 Jan 05, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE MILES

INJECTABLE;INJE

CTION 2% A080414 Jan 05, 1972

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 1% A080377 Feb 20, 1974

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 1% A083627 Jul 01, 1977

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 2% A080377 Feb 20, 1974

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NUMBER

APPROVAL DATE

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 2% A083627 Jul 01, 1977

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 1% A083083 Aug 29, 1975

LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 2% A083083 Aug 29, 1975

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.2% 

IN DEXTROSE 5% HOSPIRA

INJECTABLE;INJE

CTION 200MG/100ML A083158 Feb 25, 1980

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 0.4% 

IN DEXTROSE 5% HOSPIRA

INJECTABLE;INJE

CTION 400MG/100ML A083158 Feb 25, 1980

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE IN 

PLASTIC CONTAINER HOSPIRA

INJECTABLE;INJE

CTION 1.5% A088326 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE IN 

PLASTIC CONTAINER HOSPIRA

INJECTABLE;INJE

CTION 10% A088367 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE IN 

PLASTIC CONTAINER HOSPIRA

INJECTABLE;INJE

CTION 20% A088368 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

VISCOUS ACTAVIS MID ATLANTIC SOLUTION;ORAL 2% A086578 May 09, 1980

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE 

VISCOUS INTL MEDICATION SOLUTION;ORAL 2% A086389 Feb 02, 1982

LIDOCAINE HYDROCHLORIDE LIDOCATON PHARMATON

INJECTABLE;INJE

CTION 2% A084727 Aug 17, 1983

LIDOCAINE HYDROCHLORIDE LTA II KIT HOSPIRA

SOLUTION;TOPICA

L 4% A080409 Apr 06, 1972

LIDOCAINE HYDROCHLORIDE LTA II KIT HOSPIRA

SOLUTION;TOPICA

L 4% A088542 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE PEDIATRIC LTA KIT ABBOTT

SOLUTION;TOPICA

L 2% A088572 Jul 31, 1984

LIDOCAINE HYDROCHLORIDE PEDIATRIC LTA KIT HOSPIRA

SOLUTION;TOPICA

L 2% A085995 Nov 17, 1977

LINDANE GAMENE SOLA BARNES HIND LOTION;TOPICAL 1% A084989 Jun 15, 1976

LINDANE GAMENE SOLA BARNES HIND SHAMPOO;TOPICAL 1% A084988 Jun 15, 1976

LINDANE KWELL REED AND CARNRICK CREAM;TOPICAL 1% A084218 Dec 19, 1974

LINDANE KWELL REED AND CARNRICK LOTION;TOPICAL 1% A084218 Dec 19, 1974

LINDANE KWELL REED AND CARNRICK SHAMPOO;TOPICAL 1% A084219 Jan 22, 1975

LINDANE LINDANE OLTA PHARMS LOTION;TOPICAL 1% A087313 Dec 17, 1981

LINDANE LINDANE OLTA PHARMS SHAMPOO;TOPICAL 1% A087266 Dec 17, 1981

LINDANE LINDANE WOCKHARDT BIO AG LOTION;TOPICAL 1% A088190 Aug 16, 1984

LINDANE SCABENE STIEFEL LOTION;TOPICAL 1% A086769 Dec 17, 1979

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NUMBER

APPROVAL DATE

LINDANE SCABENE STIEFEL SHAMPOO;TOPICAL 1% A087940 Apr 08, 1983

LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM WATSON LABS TABLET;ORAL

EQ 0.025MG 

BASE A085755 Jan 25, 1982

LIOTHYRONINE SODIUM LIOTHYRONINE SODIUM WATSON LABS TABLET;ORAL EQ 0.05MG BASE A085753 Feb 03, 1982

MANNITOL MANNITOL 25% ABRAXIS PHARM

INJECTABLE;INJE

CTION 12.5GM/50ML A086754 Jun 10, 1980

MANNITOL MANNITOL 25% INTL MEDICATION

INJECTABLE;INJE

CTION 12.5GM/50ML A083051 Aug 29, 1975

MANNITOL MANNITOL 25% LUITPOLD

INJECTABLE;INJE

CTION 12.5GM/50ML A087409 Jan 21, 1982

MANNITOL MANNITOL 25% WATSON LABS

INJECTABLE;INJE

CTION 12.5GM/50ML A087460 Jun 27, 1983

MANNITOL; SORBITOL SORBITOL-MANNITOL HOSPIRA

SOLUTION;IRRIGA

TION

540MG/100ML;2.

7GM/100ML A080224 Aug 20, 1971

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ABC HOLDING TABLET;ORAL 12.5MG A085253 Feb 07, 1977

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ABC HOLDING TABLET;ORAL 25MG A085252 Feb 15, 1977

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ANABOLIC TABLET;ORAL 25MG A085891 May 31, 1978

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 12.5MG A085269 Nov 11, 1976

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 25MG A084657 Dec 01, 1975

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 25MG A085740 Jul 06, 1977

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE BUNDY TABLET;ORAL 12.5MG A084382 Jul 12, 1978

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE BUNDY TABLET;ORAL 25MG A084872 Jul 12, 1978

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS

TABLET, 

CHEWABLE;ORAL 25MG A084976 Oct 04, 1976

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 12.5MG A083784 Dec 05, 1975

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 12.5MG A085524 Jun 08, 1977

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE KV PHARM TABLET;ORAL 25MG A085523 Jun 03, 1977

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE NEXGEN PHARMA INC

TABLET, 

CHEWABLE;ORAL 25MG A086392 Sep 14, 1978

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE UDL TABLET;ORAL 12.5MG A088256 Jun 13, 1983

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE UDL TABLET;ORAL 25MG A088257 Jun 13, 1983

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE VANGARD TABLET;ORAL 12.5MG A087877 Apr 20, 1982

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE VANGARD TABLET;ORAL 25MG A087620 Jan 04, 1982

MECLIZINE HYDROCHLORIDE MECLIZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 12.5MG A085195 Jan 31, 1977

MEDROXYPROGESTERONE ACETATE AMEN AMARIN PHARMS TABLET;ORAL 10MG A083242 May 15, 1974

MEDROXYPROGESTERONE ACETATE CURRETAB SOLVAY TABLET;ORAL 10MG A085686 Apr 28, 1978

MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE UPSHER SMITH LABS TABLET;ORAL 10MG A088484 Jul 26, 1984

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NUMBER

APPROVAL DATE

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 100MG/ML A080386 Dec 22, 1971

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 25MG/ML A080388 Dec 22, 1971

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 50MG/ML A080385 Dec 22, 1971

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 50MG/ML A080387 Dec 22, 1971

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 75MG/ML A080389 Dec 22, 1971

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE BARR TABLET;ORAL 100MG A088640 Sep 19, 1984

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE BARR TABLET;ORAL 50MG A088639 Jul 02, 1984

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 100MG/ML A088282 Jun 15, 1984

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 25MG/ML A088279 Jun 15, 1984

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 50MG/ML A088280 Jun 15, 1984

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 75MG/ML A088281 Jun 15, 1984

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE INTL MEDICATION

INJECTABLE;INJE

CTION 10MG/ML A086332 Mar 13, 1979

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PARKE DAVIS

INJECTABLE;INJE

CTION 100MG/ML A080364 May 19, 1976

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PARKE DAVIS

INJECTABLE;INJE

CTION 50MG/ML A080364 May 19, 1976

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE PARKE DAVIS

INJECTABLE;INJE

CTION 75MG/ML A080364 May 19, 1976

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 100MG A080448 Oct 15, 1976

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 50MG A080448 Oct 15, 1976

MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE WYETH AYERST TABLET;ORAL 50MG A080454 Jul 31, 1973

MEPERIDINE HYDROCHLORIDE

MEPERIDINE HYDROCHLORIDE 

PRESERVATIVE FREE ICU MEDICAL INC

INJECTABLE;INJE

CTION 10MG/ML A088432 Aug 16, 1984

MEPIVACAINE HYDROCHLORIDE ARESTOCAINE HYDROCHLORIDE SOLVAY

INJECTABLE;INJE

CTION 3% A084777 Apr 18, 1982

MEPIVACAINE HYDROCHLORIDE ISOCAINE HYDROCHLORIDE SEPTODONT INC

INJECTABLE;INJE

CTION 3% A080925 Oct 17, 1972

MEPIVACAINE HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE BELMORA LLC

INJECTABLE;INJE

CTION 3% A083559 Dec 04, 1973

MEPIVACAINE HYDROCHLORIDE MEPIVACAINE HYDROCHLORIDE INTL MEDICATION SYS

INJECTABLE;INJE

CTION 1% A087509 Oct 05, 1982

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NUMBER

APPROVAL DATE

MEPIVACAINE HYDROCHLORIDE POLOCAINE DENTSPLY PHARM

INJECTABLE;INJE

CTION 3% A088653 Aug 21, 1984

MEPROBAMATE AMOSENE FERNDALE LABS TABLET;ORAL 400MG A084030 May 10, 1974

MEPROBAMATE BAMATE ALRA TABLET;ORAL 200MG A080380 Jul 29, 1971

MEPROBAMATE BAMATE ALRA TABLET;ORAL 400MG A080380 Jul 29, 1971

MEPROBAMATE MEPROBAMATE ACELLA TABLET;ORAL 400MG A084153 Jul 03, 1974

MEPROBAMATE MEPROBAMATE BARR TABLET;ORAL 600MG A084230 Jul 10, 1974

MEPROBAMATE MEPROBAMATE HEATHER TABLET;ORAL 600MG A084329 Nov 29, 1978

MEPROBAMATE MEPROBAMATE IVAX SUB TEVA PHARMS TABLET;ORAL 600MG A084181 Apr 29, 1974

MEPROBAMATE MEPROBAMATE LEDERLE TABLET;ORAL 400MG A086299 Jul 06, 1978

MEPROBAMATE MEPROBAMATE MYLAN TABLET;ORAL 400MG A083618 Dec 26, 1973

MEPROBAMATE MEPROBAMATE NEXGEN PHARMA INC TABLET;ORAL 200MG A084220 Sep 30, 1974

MEPROBAMATE MEPROBAMATE NEXGEN PHARMA INC TABLET;ORAL 400MG A084589 Apr 17, 1975

MEPROBAMATE MEPROBAMATE PARKE DAVIS TABLET;ORAL 200MG A084744 Dec 09, 1975

MEPROBAMATE MEPROBAMATE PARKE DAVIS TABLET;ORAL 400MG A084744 Dec 09, 1975

MEPROBAMATE MEPROBAMATE PERRIGO TABLET;ORAL 200MG A084546 Dec 22, 1976

MEPROBAMATE MEPROBAMATE PERRIGO TABLET;ORAL 400MG A084547 Nov 16, 1976

MEPROBAMATE MEPROBAMATE PHARMAVITE TABLET;ORAL 400MG A084438 Jun 12, 1975

MEPROBAMATE MEPROBAMATE PUREPAC PHARM TABLET;ORAL 200MG A084804 Jul 19, 1979

MEPROBAMATE MEPROBAMATE PUREPAC PHARM TABLET;ORAL 400MG A084804 Jul 19, 1979

MEPROBAMATE MEPROBAMATE RISING TABLET;ORAL 400MG A080655 Jul 12, 1972

MEPROBAMATE MEPROBAMATE ROXANE TABLET;ORAL 600MG A084332 May 05, 1975

MEPROBAMATE MEPROBAMATE SCHERER LABS TABLET;ORAL 400MG A083343 Aug 01, 1973

MEPROBAMATE MEPROBAMATE SOLVAY TABLET;ORAL 200MG A084435 Apr 02, 1975

MEPROBAMATE MEPROBAMATE SUN PHARM INDUSTRIES TABLET;ORAL 200MG A080699 Oct 16, 1972

MEPROBAMATE MEPROBAMATE SUN PHARM INDUSTRIES TABLET;ORAL 400MG A080699 Oct 16, 1972

MEPROBAMATE MEPROBAMATE TABLICAPS TABLET;ORAL 400MG A083494 Aug 31, 1973

MEPROBAMATE MEPROBAMATE USL PHARMA TABLET;ORAL 200MG A087825 Mar 18, 1982

MEPROBAMATE MEPROBAMATE USL PHARMA TABLET;ORAL 400MG A087826 Mar 18, 1982

MEPROBAMATE MEPROBAMATE VANGARD TABLET;ORAL 400MG A088011 Jul 14, 1982

MEPROBAMATE MEPROBAMATE WATSON LABS TABLET;ORAL 200MG A083304 Apr 23, 1973

MEPROBAMATE MEPROBAMATE WATSON LABS TABLET;ORAL 400MG A083308 May 03, 1973

MEPROBAMATE MEPROBAMATE WATSON LABS TABLET;ORAL 200MG A085720 Jul 13, 1977

MEPROBAMATE MEPROBAMATE WATSON LABS TABLET;ORAL 400MG A085721 Jul 13, 1977

MEPROBAMATE MEPROBAMATE WATSON LABS TABLET;ORAL 600MG A084274 Nov 11, 1976

MEPROBAMATE MEPROBAMATE WATSON LABS TABLET;ORAL 600MG A085719 Jul 13, 1977

MEPROBAMATE MEPROBAMATE WHITEWORTH TOWN PLSN TABLET;ORAL 200MG A083830 Feb 13, 1974

MEPROBAMATE MEPROBAMATE WHITEWORTH TOWN PLSN TABLET;ORAL 400MG A083442 Dec 20, 1973

MEPROBAMATE MILTOWN MEDPOINTE PHARM HLC TABLET;ORAL 600MG A083919 Jan 28, 1974

MEPROBAMATE TRANMEP SOLVAY TABLET;ORAL 400MG A084369 Jan 31, 1975

MERSALYL SODIUM; 

THEOPHYLLINE MERSALYL-THEOPHYLLINE WATSON LABS

INJECTABLE;INJE

CTION

100MG/ML;50MG/

ML A084875 Mar 23, 1977

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NUMBER

APPROVAL DATE

METARAMINOL BITARTRATE METARAMINOL BITARTRATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 10MG 

BASE/ML A080431 Sep 22, 1972

METARAMINOL BITARTRATE METARAMINOL BITARTRATE ELKINS SINN

INJECTABLE;INJE

CTION

EQ 10MG 

BASE/ML A083363 Feb 20, 1974

METARAMINOL BITARTRATE METARAMINOL BITARTRATE FRESENIUS KABI USA

INJECTABLE;INJE

CTION

EQ 10MG 

BASE/ML A080722 Apr 17, 1972

METARAMINOL BITARTRATE METARAMINOL BITARTRATE GD SEARLE LLC

INJECTABLE;INJE

CTION

EQ 10MG 

BASE/ML A086418 May 31, 1979

METARAMINOL BITARTRATE METARAMINOL BITARTRATE GD SEARLE LLC

INJECTABLE;INJE

CTION

EQ 20MG 

BASE/ML A086418 May 31, 1979

METHAMPHETAMINE 

HYDROCHLORIDE METHAMPEX TEVA TABLET;ORAL 10MG A083889 Oct 20, 1975

METHAMPHETAMINE 

HYDROCHLORIDE

METHAMPHETAMINE 

HYDROCHLORIDE REXAR TABLET;ORAL 5MG A084931 Jan 19, 1976

METHAMPHETAMINE 

HYDROCHLORIDE

METHAMPHETAMINE 

HYDROCHLORIDE REXAR TABLET;ORAL 10MG A084931 Aug 22, 1977

METHAMPHETAMINE 

HYDROCHLORIDE

METHAMPHETAMINE 

HYDROCHLORIDE TEVA TABLET;ORAL 5MG A086359 Dec 16, 1981

METHDILAZINE HYDROCHLORIDE METHDILAZINE HYDROCHLORIDE ALPHARMA US PHARMS SYRUP;ORAL 4MG/5ML A087122 Jul 09, 1981

METHOCARBAMOL DELAXIN FERNDALE LABS TABLET;ORAL 500MG A085454 Aug 03, 1977

METHOCARBAMOL FORBAXIN FOREST LABS TABLET;ORAL 750MG A085136 Jul 29, 1976

METHOCARBAMOL METHOCARBAMOL ANI PHARMS TABLET;ORAL 500MG A084277 Mar 14, 1977

METHOCARBAMOL METHOCARBAMOL ANI PHARMS TABLET;ORAL 750MG A084276 Jul 14, 1977

METHOCARBAMOL METHOCARBAMOL ASCOT TABLET;ORAL 500MG A087660 Oct 27, 1982

METHOCARBAMOL METHOCARBAMOL ASCOT TABLET;ORAL 750MG A087661 Oct 27, 1982

METHOCARBAMOL METHOCARBAMOL CLONMEL HLTHCARE TABLET;ORAL 500MG A085961 Dec 19, 1977

METHOCARBAMOL METHOCARBAMOL CLONMEL HLTHCARE TABLET;ORAL 750MG A085963 Dec 19, 1977

METHOCARBAMOL METHOCARBAMOL DR REDDYS

INJECTABLE;INJE

CTION 100MG/ML A086459 Jul 03, 1980

METHOCARBAMOL METHOCARBAMOL FOSUN PHARMA TABLET;ORAL 500MG A084616 Dec 19, 1975

METHOCARBAMOL METHOCARBAMOL FOSUN PHARMA TABLET;ORAL 750MG A084615 Dec 19, 1975

METHOCARBAMOL METHOCARBAMOL HEATHER TABLET;ORAL 500MG A084675 Feb 03, 1976

METHOCARBAMOL METHOCARBAMOL HEATHER TABLET;ORAL 750MG A084924 Feb 23, 1976

METHOCARBAMOL METHOCARBAMOL HIKMA INTL PHARMS TABLET;ORAL 500MG A085159 Aug 11, 1976

METHOCARBAMOL METHOCARBAMOL HIKMA INTL PHARMS TABLET;ORAL 750MG A085123 Aug 18, 1976

METHOCARBAMOL METHOCARBAMOL IMPAX LABS TABLET;ORAL 500MG A084927 Aug 20, 1976

METHOCARBAMOL METHOCARBAMOL IMPAX LABS TABLET;ORAL 750MG A084928 Aug 20, 1976

METHOCARBAMOL METHOCARBAMOL INWOOD LABS TABLET;ORAL 500MG A085137 Aug 03, 1976

METHOCARBAMOL METHOCARBAMOL IVAX SUB TEVA PHARMS TABLET;ORAL 500MG A084648 Mar 11, 1977

METHOCARBAMOL METHOCARBAMOL IVAX SUB TEVA PHARMS TABLET;ORAL 750MG A084649 Mar 11, 1977

METHOCARBAMOL METHOCARBAMOL KV PHARM TABLET;ORAL 500MG A085660 Feb 20, 1980

Current as of July 2021 Page 84 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

METHOCARBAMOL METHOCARBAMOL KV PHARM TABLET;ORAL 750MG A085658 Feb 19, 1980

METHOCARBAMOL METHOCARBAMOL LANNETT CO INC TABLET;ORAL 750MG A084756 Nov 23, 1976

METHOCARBAMOL METHOCARBAMOL MYLAN TABLET;ORAL 500MG A084259 Dec 20, 1974

METHOCARBAMOL METHOCARBAMOL MYLAN TABLET;ORAL 750MG A084323 Feb 25, 1975

METHOCARBAMOL METHOCARBAMOL NYLOS TABLET;ORAL 750MG A085033 Mar 01, 1977

METHOCARBAMOL METHOCARBAMOL PURACAP PHARM TABLET;ORAL 500MG A084231 Jul 15, 1975

METHOCARBAMOL METHOCARBAMOL PURACAP PHARM TABLET;ORAL 750MG A084471 Feb 25, 1974

METHOCARBAMOL METHOCARBAMOL PUREPAC PHARM TABLET;ORAL 500MG A085718 Feb 15, 1979

METHOCARBAMOL METHOCARBAMOL PUREPAC PHARM TABLET;ORAL 750MG A085718 Feb 15, 1979

METHOCARBAMOL METHOCARBAMOL ROXANE TABLET;ORAL 500MG A088646 Feb 29, 1984

METHOCARBAMOL METHOCARBAMOL ROXANE TABLET;ORAL 750MG A088647 Feb 29, 1984

METHOCARBAMOL METHOCARBAMOL SANDOZ TABLET;ORAL 500MG A087283 Oct 15, 1981

METHOCARBAMOL METHOCARBAMOL SANDOZ TABLET;ORAL 750MG A087282 Oct 15, 1981

METHOCARBAMOL METHOCARBAMOL SOLVAY TABLET;ORAL 500MG A084448 Aug 25, 1976

METHOCARBAMOL METHOCARBAMOL SOLVAY TABLET;ORAL 750MG A084449 Aug 25, 1976

METHOCARBAMOL METHOCARBAMOL SUN PHARM INDUSTRIES TABLET;ORAL 500MG A084488 May 28, 1975

METHOCARBAMOL METHOCARBAMOL SUN PHARM INDUSTRIES TABLET;ORAL 750MG A084486 May 16, 1975

METHOCARBAMOL METHOCARBAMOL SUPERPHARM TABLET;ORAL 500MG A087589 Jan 22, 1982

METHOCARBAMOL METHOCARBAMOL SUPERPHARM TABLET;ORAL 750MG A087590 Jan 22, 1982

METHOCARBAMOL METHOCARBAMOL TABLICAPS TABLET;ORAL 500MG A084846 Mar 04, 1976

METHOCARBAMOL METHOCARBAMOL UPSHER SMITH TABLET;ORAL 500MG A087453 Oct 02, 1981

METHOCARBAMOL METHOCARBAMOL UPSHER SMITH TABLET;ORAL 750MG A087454 Oct 02, 1981

METHOCARBAMOL METHOCARBAMOL WATSON LABS TABLET;ORAL 500MG A083605 Dec 06, 1974

METHOCARBAMOL METHOCARBAMOL WATSON LABS TABLET;ORAL 500MG A085180 Aug 26, 1976

METHOCARBAMOL METHOCARBAMOL WATSON LABS TABLET;ORAL 750MG A083605 Dec 06, 1974

METHOCARBAMOL METHOCARBAMOL WATSON LABS TABLET;ORAL 750MG A085192 Aug 20, 1976

METHOTREXATE SODIUM FOLEX PHARMACIA AND UPJOHN

INJECTABLE;INJE

CTION

EQ 25MG 

BASE/VIAL A087695 Apr 08, 1983

METHOTREXATE SODIUM FOLEX PHARMACIA AND UPJOHN

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A087695 Apr 08, 1983

METHOTREXATE SODIUM FOLEX PHARMACIA AND UPJOHN

INJECTABLE;INJE

CTION

EQ 50MG 

BASE/VIAL A087695 Apr 08, 1983

METHOTREXATE SODIUM MEXATE BRISTOL

INJECTABLE;INJE

CTION

EQ 20MG 

BASE/VIAL A086358 Sep 05, 1979

METHOTREXATE SODIUM MEXATE BRISTOL

INJECTABLE;INJE

CTION

EQ 250MG 

BASE/VIAL A086358 Jun 23, 1981

METHOTREXATE SODIUM MEXATE BRISTOL

INJECTABLE;INJE

CTION

EQ 100MG 

BASE/VIAL A086358 Sep 05, 1979

METHOTREXATE SODIUM MEXATE BRISTOL

INJECTABLE;INJE

CTION

EQ 50MG 

BASE/VIAL A086358 Sep 05, 1979

METHOXSALEN METHOXSALEN ANI PHARMS CAPSULE;ORAL 10MG A087781 Jun 08, 1982

METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE PVT FORM TABLET;ORAL 2.5MG A080970 Oct 18, 1976

METHYCLOTHIAZIDE METHYCLOTHIAZIDE IVAX PHARMS TABLET;ORAL 2.5MG A087913 Jun 03, 1982

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

METHYCLOTHIAZIDE METHYCLOTHIAZIDE IVAX PHARMS TABLET;ORAL 5MG A087786 May 18, 1982

METHYCLOTHIAZIDE METHYCLOTHIAZIDE MYLAN TABLET;ORAL 2.5MG A087671 Aug 17, 1982

METHYCLOTHIAZIDE METHYCLOTHIAZIDE MYLAN PHARMS INC TABLET;ORAL 5MG A087672 Aug 17, 1982

METHYCLOTHIAZIDE METHYCLOTHIAZIDE WATSON LABS TABLET;ORAL 2.5MG A085487 Mar 11, 1982

METHYCLOTHIAZIDE METHYCLOTHIAZIDE WATSON LABS TABLET;ORAL 2.5MG A088750 Sep 06, 1984

METHYCLOTHIAZIDE METHYCLOTHIAZIDE WATSON LABS TABLET;ORAL 5MG A085476 Mar 11, 1982

METHYCLOTHIAZIDE METHYCLOTHIAZIDE WATSON LABS TABLET;ORAL 5MG A088724 Sep 06, 1984

METHYLPHENIDATE 

HYDROCHLORIDE

METHYLPHENIDATE 

HYDROCHLORIDE LANNETT CO INC TABLET;ORAL 10MG A085799 Dec 23, 1977

METHYLPHENIDATE 

HYDROCHLORIDE

METHYLPHENIDATE 

HYDROCHLORIDE LANNETT CO INC TABLET;ORAL 20MG A086428 Apr 04, 1979

METHYLPHENIDATE 

HYDROCHLORIDE

METHYLPHENIDATE 

HYDROCHLORIDE LANNETT CO INC TABLET;ORAL 5MG A086429 Apr 04, 1979

METHYLPREDNISOLONE METHYLPREDNISOLONE DURAMED PHARMS BARR TABLET;ORAL 4MG A088497 Feb 21, 1984

METHYLPREDNISOLONE METHYLPREDNISOLONE HEATHER TABLET;ORAL 4MG A085650 Jul 11, 1977

METHYLPREDNISOLONE METHYLPREDNISOLONE INVATECH TABLET;ORAL 4MG A087341 Jul 28, 1981

METHYLPREDNISOLONE METHYLPREDNISOLONE WATSON LABS TABLET;ORAL 16MG A086159 Feb 09, 1982

METHYLPREDNISOLONE METHYLPREDNISOLONE WATSON LABS TABLET;ORAL 4MG A086161 Feb 09, 1982

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE AKORN

INJECTABLE;INJE

CTION 40MG/ML A086903 Oct 20, 1982

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE AKORN

INJECTABLE;INJE

CTION 80MG/ML A086903 Oct 20, 1982

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 40MG/ML A085374 Mar 14, 1979

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 80MG/ML A086507 Sep 15, 1981

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 20MG/ML A085597 Mar 14, 1979

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 40MG/ML A085600 Mar 14, 1979

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 80MG/ML A085595 Mar 26, 1979

METHYLPREDNISOLONE ACETATE METHYLPREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 20MG/ML A087248 Sep 15, 1981

METHYLPREDNISOLONE ACETATE M-PREDROL BEL MAR

INJECTABLE;INJE

CTION 40MG/ML A086666 Dec 06, 1979

METHYLPREDNISOLONE ACETATE M-PREDROL BEL MAR

INJECTABLE;INJE

CTION 80MG/ML A087135 Jan 13, 1981

METHYLPREDNISOLONE SODIUM 

SUCCINATE A-METHAPRED HOSPIRA

INJECTABLE;INJE

CTION

EQ 125MG 

BASE/VIAL A085855 Mar 28, 1978

METHYLPREDNISOLONE SODIUM 

SUCCINATE A-METHAPRED HOSPIRA

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A085852 Mar 28, 1978

Current as of July 2021 Page 86 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE A-METHAPRED HOSPIRA

INJECTABLE;INJE

CTION

EQ 40MG 

BASE/VIAL A085853 Mar 28, 1978

METHYLPREDNISOLONE SODIUM 

SUCCINATE A-METHAPRED HOSPIRA

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A085854 Mar 28, 1978

METHYLPREDNISOLONE SODIUM 

SUCCINATE METHYLPREDNISOLONE ELKINS SINN

INJECTABLE;INJE

CTION

EQ 125MG 

BASE/VIAL A086906 Feb 15, 1980

METHYLPREDNISOLONE SODIUM 

SUCCINATE METHYLPREDNISOLONE ELKINS SINN

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A086906 Feb 15, 1980

METHYLPREDNISOLONE SODIUM 

SUCCINATE METHYLPREDNISOLONE ELKINS SINN

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A086906 Feb 15, 1980

METHYLPREDNISOLONE SODIUM 

SUCCINATE METHYLPREDNISOLONE ORGANON USA INC

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A087535 Jun 25, 1982

METHYLPREDNISOLONE SODIUM 

SUCCINATE METHYLPREDNISOLONE ORGANON USA INC

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A087535 Jun 25, 1982

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 125MG 

BASE/VIAL A088677 Jun 08, 1984

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A088679 Jun 08, 1984

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 40MG 

BASE/VIAL A088676 Jun 08, 1984

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE ABRAXIS PHARM

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A088678 Jun 08, 1984

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE ELKINS SINN

INJECTABLE;INJE

CTION

EQ 40MG 

BASE/VIAL A086906 Feb 15, 1980

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE INTL MEDICATION

INJECTABLE;INJE

CTION

EQ 125MG 

BASE/VIAL A087813 Feb 09, 1983

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE INTL MEDICATION

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A087852 Feb 09, 1983

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE INTL MEDICATION

INJECTABLE;INJE

CTION

EQ 40MG 

BASE/VIAL A087812 Feb 09, 1983

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE INTL MEDICATION

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A087851 Feb 09, 1983

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 125MG 

BASE/VIAL A087030 Jul 22, 1982

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 1GM 

BASE/VIAL A088524 Jul 24, 1984

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 40MG 

BASE/VIAL A086953 Jul 22, 1982

METHYLPREDNISOLONE SODIUM 

SUCCINATE

METHYLPREDNISOLONE SODIUM 

SUCCINATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 500MG 

BASE/VIAL A088523 Jul 24, 1984

METHYLTESTOSTERONE ANDROID 10 VALEANT PHARMS NORTH TABLET;ORAL 10MG A086450 Feb 09, 1981

METHYLTESTOSTERONE ANDROID 5 VALEANT PHARM INTL TABLET;BUCCAL 5MG A087222 Feb 09, 1981

Current as of July 2021 Page 87 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

METHYLTESTOSTERONE METHYLTESTOSTERONE HEATHER CAPSULE;ORAL 10MG A084967 Jun 23, 1976

METHYLTESTOSTERONE METHYLTESTOSTERONE IMPAX LABS

TABLET;BUCCAL, 

SUBLINGUAL 10MG A084287 Jul 16, 1974

METHYLTESTOSTERONE METHYLTESTOSTERONE IMPAX LABS TABLET;ORAL 25MG A084310 Jun 21, 1974

METHYLTESTOSTERONE METHYLTESTOSTERONE INWOOD LABS TABLET;ORAL 10MG A080839 Jul 24, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE INWOOD LABS TABLET;ORAL 25MG A080973 Sep 15, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE KV PHARM TABLET;ORAL 10MG A084312 Oct 08, 1976

METHYLTESTOSTERONE METHYLTESTOSTERONE LANNETT TABLET;ORAL 10MG A087092 Nov 05, 1982

METHYLTESTOSTERONE METHYLTESTOSTERONE LANNETT TABLET;ORAL 25MG A087111 Jan 27, 1983

METHYLTESTOSTERONE METHYLTESTOSTERONE LILLY

TABLET;BUCCAL, 

SUBLINGUAL 10MG A080256 Dec 22, 1971

METHYLTESTOSTERONE METHYLTESTOSTERONE LILLY

TABLET;BUCCAL, 

SUBLINGUAL 25MG A080256 Dec 22, 1971

METHYLTESTOSTERONE METHYLTESTOSTERONE PARKE DAVIS TABLET;ORAL 10MG A084244 Sep 16, 1974

METHYLTESTOSTERONE METHYLTESTOSTERONE PARKE DAVIS TABLET;ORAL 25MG A084241 Sep 23, 1974

METHYLTESTOSTERONE METHYLTESTOSTERONE PUREPAC PHARM

TABLET;BUCCAL, 

SUBLINGUAL 10MG A080308 Mar 30, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE PUREPAC PHARM

TABLET;BUCCAL, 

SUBLINGUAL 10MG A080475 Jul 12, 1973

METHYLTESTOSTERONE METHYLTESTOSTERONE PUREPAC PHARM

TABLET;BUCCAL, 

SUBLINGUAL 10MG A080475 Jul 12, 1973

METHYLTESTOSTERONE METHYLTESTOSTERONE PUREPAC PHARM

TABLET;BUCCAL, 

SUBLINGUAL 25MG A080475 Jul 12, 1973

METHYLTESTOSTERONE METHYLTESTOSTERONE PUREPAC PHARM TABLET;ORAL 10MG A080309 Mar 31, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE PUREPAC PHARM TABLET;ORAL 25MG A080310 Mar 30, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE PVT FORM

TABLET;BUCCAL, 

SUBLINGUAL 5MG A083836 Sep 07, 1976

METHYLTESTOSTERONE METHYLTESTOSTERONE PVT FORM TABLET;ORAL 10MG A080214 Jul 20, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE PVT FORM TABLET;ORAL 25MG A080214 Nov 09, 1977

METHYLTESTOSTERONE METHYLTESTOSTERONE PVT FORM TABLET;ORAL 5MG A080214 Jul 20, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE TABLICAPS

TABLET;BUCCAL, 

SUBLINGUAL 10MG A085125 Feb 02, 1977

METHYLTESTOSTERONE METHYLTESTOSTERONE TABLICAPS TABLET;ORAL 10MG A080313 Feb 14, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE TABLICAPS TABLET;ORAL 25MG A085270 Jun 03, 1977

METHYLTESTOSTERONE METHYLTESTOSTERONE USL PHARMA

TABLET;BUCCAL, 

SUBLINGUAL 10MG A080271 Jun 24, 1976

METHYLTESTOSTERONE METHYLTESTOSTERONE WATSON LABS TABLET;ORAL 10MG A080933 Dec 20, 1973

METHYLTESTOSTERONE METHYLTESTOSTERONE WATSON LABS TABLET;ORAL 25MG A080931 Dec 12, 1972

METHYLTESTOSTERONE METHYLTESTOSTERONE WEST WARD TABLET;ORAL 10MG A084331 Jun 12, 1975

METHYLTESTOSTERONE METHYLTESTOSTERONE WEST WARD TABLET;ORAL 25MG A084331 Jun 12, 1975

METHYLTESTOSTERONE METHYLTESTOSTERONE WEST WARD TABLET;ORAL 25MG A084642 Jun 25, 1975

METHYLTESTOSTERONE ORETON SCHERING TABLET;BUCCAL 10MG A080281 Aug 03, 1979

Current as of July 2021 Page 88 of 130
PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

METHYLTESTOSTERONE TESTRED BAUSCH CAPSULE;ORAL 10MG A083976 Dec 03, 1973

METHYLTESTOSTERONE VIRILON CHARTWELL CAPSULE;ORAL 10MG A087750 Nov 24, 1982

NANDROLONE DECANOATE NANDROLONE DECANOATE ABRAXIS PHARM

INJECTABLE;INJE

CTION 100MG/ML A088290 Oct 03, 1983

NANDROLONE DECANOATE NANDROLONE DECANOATE ABRAXIS PHARM

INJECTABLE;INJE

CTION 200MG/ML A088317 Oct 14, 1983

NANDROLONE DECANOATE NANDROLONE DECANOATE AKORN

INJECTABLE;INJE

CTION 100MG/ML A087519 Sep 28, 1983

NANDROLONE DECANOATE NANDROLONE DECANOATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A086598 Jan 13, 1984

NANDROLONE DECANOATE NANDROLONE DECANOATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A087599 Oct 06, 1983

NANDROLONE DECANOATE NANDROLONE DECANOATE WATSON LABS

INJECTABLE;INJE

CTION 200MG/ML A088128 Dec 05, 1983

NANDROLONE DECANOATE NANDROLONE DECANOATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A086385 Jan 13, 1984

NANDROLONE DECANOATE NANDROLONE DECANOATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A087598 Oct 06, 1983

NANDROLONE PHENPROPIONATE NANDROLONE PHENPROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A086386 Jun 17, 1983

NANDROLONE PHENPROPIONATE NANDROLONE PHENPROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A087488 Jun 17, 1983

NAPHAZOLINE HYDROCHLORIDE ALBALON ALLERGAN

SOLUTION/DROPS;

OPHTHALMIC 0.1% A080248 Mar 24, 1972

NAPHAZOLINE HYDROCHLORIDE NAFAZAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 0.1% A088101 Apr 15, 1983

NAPHAZOLINE HYDROCHLORIDE NAPHAZOLINE HYDROCHLORIDE AKORN

SOLUTION/DROPS;

OPHTHALMIC 0.1% A083590 Aug 22, 1974

NAPHAZOLINE HYDROCHLORIDE NAPHCON FORTE ALCON

SOLUTION/DROPS;

OPHTHALMIC 0.1% A080229 Mar 06, 1974

NAPHAZOLINE HYDROCHLORIDE OPCON BAUSCH AND LOMB

SOLUTION/DROPS;

OPHTHALMIC 0.1% A087506 Dec 01, 1981

NAPHAZOLINE HYDROCHLORIDE VASOCON NOVARTIS

SOLUTION/DROPS;

OPHTHALMIC 0.1% A080235 Mar 24, 1983

NIACIN NIACIN EVERYLIFE TABLET;ORAL 500MG A083203 Feb 13, 1973

NIACIN NIACIN HALSEY TABLET;ORAL 500MG A083453 Jan 26, 1976

NIACIN NIACIN HIKMA TABLET;ORAL 500MG A083718 Jan 07, 1974

NIACIN NIACIN IMPAX LABS TABLET;ORAL 500MG A083115 Jul 19, 1973

NIACIN NIACIN IVAX SUB TEVA PHARMS TABLET;ORAL 500MG A083180 Sep 15, 1972

NIACIN NIACIN MK LABS TABLET;ORAL 500MG A083525 Aug 01, 1973

NIACIN NIACIN PUREPAC PHARM TABLET;ORAL 500MG A083271 Jul 11, 1977

NIACIN NIACIN SANDOZ TABLET;ORAL 500MG A083306 Mar 26, 1973

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

NIACIN NIACIN TABLICAPS TABLET;ORAL 500MG A084237 Jul 24, 1975

NIACIN NIACIN WATSON LABS TABLET;ORAL 500MG A083136 Jan 04, 1973

NIACIN NIACIN WATSON LABS TABLET;ORAL 500MG A083305 Oct 10, 1973

NIACIN NIACIN WATSON LABS TABLET;ORAL 500MG A085172 Jul 30, 1976

NIACIN NICOLAR SANOFI AVENTIS US TABLET;ORAL 500MG A083823 Nov 26, 1973

NITROFURANTOIN FURALAN LANNETT TABLET;ORAL 100MG A080017 Sep 30, 1970

NITROFURANTOIN FURALAN LANNETT TABLET;ORAL 50MG A080017 Sep 30, 1970

NITROFURANTOIN NITROFURANTOIN ELKINS SINN TABLET;ORAL 100MG A080003 Sep 30, 1970

NITROFURANTOIN NITROFURANTOIN ELKINS SINN TABLET;ORAL 50MG A080003 Sep 30, 1970

NITROFURANTOIN NITROFURANTOIN IVAX SUB TEVA PHARMS TABLET;ORAL 100MG A080078 Dec 28, 1970

NITROFURANTOIN NITROFURANTOIN IVAX SUB TEVA PHARMS TABLET;ORAL 50MG A080078 Apr 02, 1971

NITROFURANTOIN NITROFURANTOIN SANDOZ TABLET;ORAL 100MG A080043 Nov 25, 1970

NITROFURANTOIN NITROFURANTOIN SANDOZ TABLET;ORAL 50MG A080043 Nov 25, 1970

NITROFURANTOIN NITROFURANTOIN WATSON LABS CAPSULE;ORAL 100MG A084326 Nov 07, 1974

NITROFURANTOIN NITROFURANTOIN WATSON LABS CAPSULE;ORAL 50MG A084326 Nov 07, 1974

NITROFURANTOIN NITROFURANTOIN WATSON LABS TABLET;ORAL 100MG A080447 Nov 16, 1973

NITROFURANTOIN NITROFURANTOIN WATSON LABS TABLET;ORAL 100MG A085796 Nov 22, 1978

NITROFURANTOIN NITROFURANTOIN WATSON LABS TABLET;ORAL 50MG A085797 Dec 05, 1978

NITROFURANTOIN NITROFURANTOIN WATSON LABS TABLET;ORAL 50MG A080447 Jul 20, 1972

NITROFURANTOIN NITROFURANTOIN WHITEWORTH TOWN PLSN TABLET;ORAL 100MG A084085 Jan 31, 1974

NITROFURAZONE FURACIN SHIRE CREAM;TOPICAL 0.2% A083789 Nov 06, 1975

NITROFURAZONE FURACIN SHIRE POWDER;TOPICAL 0.2% A083791 Oct 17, 1975

NITROFURAZONE NITROFURAZONE AMBIX

OINTMENT;TOPICA

L 0.2% A086077 Apr 26, 1978

NITROFURAZONE NITROFURAZONE LANNETT

OINTMENT;TOPICA

L 0.2% A084393 Jun 05, 1975

NITROFURAZONE NITROFURAZONE PERRIGO NEW YORK

OINTMENT;TOPICA

L 0.2% A084968 Jan 25, 1978

NITROFURAZONE NITROFURAZONE PERRIGO NEW YORK

SOLUTION;TOPICA

L 0.2% A085130 Nov 02, 1978

NITROFURAZONE NITROFURAZONE TARO

OINTMENT;TOPICA

L 0.2% A086156 Aug 15, 1978

NITROFURAZONE NITROFURAZONE WENDT

OINTMENT;TOPICA

L 0.2% A086766 May 11, 1981

NITROFURAZONE NITROFURAZONE WENDT

SOLUTION;TOPICA

L 0.2% A087081 Jul 22, 1981

ORPHENADRINE CITRATE ORPHENADRINE CITRATE ASCOT

TABLET, 

EXTENDED 

RELEASE;ORAL 100MG A088067 Apr 06, 1983

ORPHENADRINE CITRATE ORPHENADRINE CITRATE SANDOZ

TABLET, 

EXTENDED 

RELEASE;ORAL 100MG A085046 May 13, 1981

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

ORPHENADRINE CITRATE ORPHENADRINE CITRATE WATSON LABS

INJECTABLE;INJE

CTION 30MG/ML A087062 Jul 16, 1981

ORPHENADRINE CITRATE ORPHENADRINE CITRATE WATSON LABS

TABLET, 

EXTENDED 

RELEASE;ORAL 100MG A084303 Oct 19, 1981

OXTRIPHYLLINE CHOLEDYL SA WARNER CHILCOTT LLC

TABLET, 

EXTENDED 

RELEASE;ORAL 400MG A087863 May 24, 1983

OXTRIPHYLLINE CHOLEDYL SA WARNER CHILCOTT LLC

TABLET, 

EXTENDED 

RELEASE;ORAL 600MG A086742 Nov 05, 1981

OXTRIPHYLLINE OXTRIPHYLLINE MORTON GROVE SOLUTION;ORAL 100MG/5ML A088243 Dec 05, 1983

OXTRIPHYLLINE OXTRIPHYLLINE WATSON LABS

TABLET, DELAYED 

RELEASE;ORAL 100MG A087866 Aug 25, 1983

OXTRIPHYLLINE OXTRIPHYLLINE WATSON LABS

TABLET, DELAYED 

RELEASE;ORAL 200MG A087835 Aug 25, 1983

OXTRIPHYLLINE OXTRIPHYLLINE PEDIATRIC MORTON GROVE SYRUP;ORAL 50MG/5ML A088242 Dec 05, 1983

OXYPHENBUTAZONE OXYPHENBUTAZONE WATSON LABS TABLET;ORAL 100MG A088399 Sep 17, 1984

PENTOBARBITAL NEMBUTAL AKORN ELIXIR;ORAL 18.2MG/5ML A083244 Jan 08, 1975

PENTOBARBITAL SODIUM NEMBUTAL AKORN

SUPPOSITORY;REC

TAL 120MG A083247 Jan 25, 1982

PENTOBARBITAL SODIUM NEMBUTAL AKORN

SUPPOSITORY;REC

TAL 200MG A083247 Jan 25, 1982

PENTOBARBITAL SODIUM NEMBUTAL AKORN

SUPPOSITORY;REC

TAL 30MG A083247 Jan 25, 1982

PENTOBARBITAL SODIUM NEMBUTAL AKORN

SUPPOSITORY;REC

TAL 60MG A083247 Jan 25, 1982

PENTOBARBITAL SODIUM NEMBUTAL SODIUM AKORN CAPSULE;ORAL 100MG A083245 Feb 13, 1975

PENTOBARBITAL SODIUM NEMBUTAL SODIUM AKORN CAPSULE;ORAL 50MG A084093 Jan 14, 1975

PENTOBARBITAL SODIUM NEMBUTAL SODIUM AKORN CAPSULE;ORAL 30MG A084095 Feb 18, 1975

PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM ELKINS SINN

INJECTABLE;INJE

CTION 50MG/ML A083270 Nov 08, 1973

PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM LANNETT CAPSULE;ORAL 100MG A085915 Jun 30, 1978

PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM LANNETT CAPSULE;ORAL 50MG A085937 Jun 09, 1978

PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM VITARINE CAPSULE;ORAL 100MG A083284 Apr 30, 1974

PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM VITARINE TABLET;ORAL 100MG A083285 Jun 05, 1973

PENTOBARBITAL SODIUM PENTOBARBITAL SODIUM WHITEWORTH TOWN PLSN CAPSULE;ORAL 100MG A083338 Feb 05, 1974

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL ANABOLIC CAPSULE;ORAL 100MG A084590 Jan 31, 1977

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL ELKINS SINN CAPSULE;ORAL 100MG A083368 Apr 23, 1973

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL EVERYLIFE CAPSULE;ORAL 100MG A083259 Mar 06, 1973

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL HALSEY CAPSULE;ORAL 100MG A084677 Feb 23, 1976

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL IVAX SUB TEVA PHARMS CAPSULE;ORAL 100MG A083461 Aug 31, 1973

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL IVAX SUB TEVA PHARMS CAPSULE;ORAL 50MG A083461 Aug 31, 1973

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL NEXGEN PHARMA INC TABLET;ORAL 100MG A084238 Sep 23, 1974

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL PARKE DAVIS CAPSULE;ORAL 100MG A084156 Jun 27, 1974

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL PERRIGO CAPSULE;ORAL 100MG A084560 May 04, 1977

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL PUREPAC PHARM CAPSULE;ORAL 100MG A083301 Aug 01, 1977

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL VALEANT PHARM INTL CAPSULE;ORAL 100MG A083264 Feb 13, 1974

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL WATSON LABS CAPSULE;ORAL 100MG A085791 Dec 12, 1977

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL WYETH AYERST CAPSULE;ORAL 100MG A083239 Nov 13, 1973

PENTOBARBITAL SODIUM SODIUM PENTOBARBITAL WYETH AYERST

INJECTABLE;INJE

CTION 50MG/ML A083261 Dec 19, 1973

PHENDIMETRAZINE TARTRATE ADPHEN FERNDALE LABS TABLET;ORAL 35MG A083655 Sep 29, 1976

PHENDIMETRAZINE TARTRATE ALPHAZINE SANDOZ TABLET;ORAL 35MG A085034 Apr 19, 1978

PHENDIMETRAZINE TARTRATE BONTRIL VALEANT

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088021 Sep 21, 1982

PHENDIMETRAZINE TARTRATE CAM-METRAZINE ABC HOLDING TABLET;ORAL 35MG A085511 May 06, 1977

PHENDIMETRAZINE TARTRATE CAM-METRAZINE CAMALL TABLET;ORAL 35MG A085756 May 11, 1977

PHENDIMETRAZINE TARTRATE CAM-METRAZINE CHARTWELL RX TABLET;ORAL 35MG A085318 Jan 18, 1977

PHENDIMETRAZINE TARTRATE CAM-METRAZINE CHARTWELL RX TABLET;ORAL 35MG A085320 Jan 18, 1977

PHENDIMETRAZINE TARTRATE CAM-METRAZINE CHARTWELL RX TABLET;ORAL 35MG A085321 Jan 18, 1977

PHENDIMETRAZINE TARTRATE CAM-METRAZINE CHARTWELL RX TABLET;ORAL 35MG A083922 Jul 28, 1976

PHENDIMETRAZINE TARTRATE DI-METREX PVT FORM TABLET;ORAL 35MG A085698 May 09, 1977

PHENDIMETRAZINE TARTRATE MELFIAT NUMARK TABLET;ORAL 35MG A083790 Oct 20, 1975

PHENDIMETRAZINE TARTRATE MELFIAT-105 NUMARK

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A087487 Oct 13, 1982

PHENDIMETRAZINE TARTRATE METRA FOREST PHARMS TABLET;ORAL 35MG A083754 Dec 02, 1976

PHENDIMETRAZINE TARTRATE PHENAZINE MAST MM CAPSULE;ORAL 35MG A086523 Mar 13, 1979

PHENDIMETRAZINE TARTRATE PHENAZINE MAST MM CAPSULE;ORAL 35MG A086524 Mar 13, 1979

PHENDIMETRAZINE TARTRATE PHENAZINE MAST MM CAPSULE;ORAL 35MG A086525 Mar 13, 1979

PHENDIMETRAZINE TARTRATE PHENAZINE MAST MM TABLET;ORAL 35MG A087305 Oct 06, 1980

PHENDIMETRAZINE TARTRATE PHENAZINE-35 ABC HOLDING TABLET;ORAL 35MG A085512 May 06, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A083684 Jan 11, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A083686 Jan 11, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A083644 Jan 12, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A083687 Jan 13, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A084834 Sep 28, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A084835 Sep 28, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE BARR TABLET;ORAL 35MG A084831 Sep 28, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE CHARTWELL RX TABLET;ORAL 35MG A085941 Jun 27, 1983

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE CHARTWELL RX TABLET;ORAL 35MG A085761 Aug 02, 1977

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE FERNDALE LABS TABLET;ORAL 35MG A086834 Sep 15, 1983

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088111 Oct 18, 1982

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A087214 May 26, 1982

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088020 Aug 16, 1982

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088028 Aug 16, 1982

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088063 Sep 10, 1982

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088062 Sep 13, 1982

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE INWOOD LABS TABLET;ORAL 35MG A084740 Jan 13, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE INWOOD LABS TABLET;ORAL 35MG A084741 Jan 13, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE INWOOD LABS TABLET;ORAL 35MG A084742 Jan 13, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE INWOOD LABS TABLET;ORAL 35MG A084743 Jan 13, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE IVAX PHARMS TABLET;ORAL 35MG A085611 May 11, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE IVAX PHARMS TABLET;ORAL 35MG A085612 May 18, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE IVAX SUB TEVA PHARMS TABLET;ORAL 35MG A083682 Jul 22, 1976

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE KV PHARM TABLET;ORAL 35MG A085525 Jun 02, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE KV PHARM TABLET;ORAL 35MG A084141 Sep 21, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE KV PHARM TABLET;ORAL 35MG A084138 Sep 29, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE MFG CHEMISTS TABLET;ORAL 35MG A085914 Dec 07, 1979

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE NEXGEN PHARMA INC TABLET;ORAL 35MG A086020 Feb 28, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE NUMARK TABLET;ORAL 35MG A083790 Oct 20, 1975

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PVT FORM TABLET;ORAL 35MG A085199 May 09, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE PVT FORM TABLET;ORAL 35MG A085697 May 09, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SANDOZ CAPSULE;ORAL 35MG A085694 Jun 05, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SANDOZ CAPSULE;ORAL 35MG A085702 Jun 07, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SANDOZ CAPSULE;ORAL 35MG A085633 Jul 13, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SANDOZ TABLET;ORAL 35MG A085402 May 19, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SANDOZ TABLET;ORAL 35MG A085830 May 24, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SANDOZ TABLET;ORAL 35MG A086370 Sep 24, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE SOLVAY TABLET;ORAL 35MG A083993 Dec 19, 1975

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE UPSHER SMITH LABS TABLET;ORAL 35MG A084399 May 28, 1981

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE USL PHARMA TABLET;ORAL 35MG A083805 May 28, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE USL PHARMA TABLET;ORAL 35MG A084398 May 28, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VIRTUS PHARMS

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A087378 Nov 03, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VIRTUS PHARMS CAPSULE;ORAL 35MG A085695 Jun 05, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VIRTUS PHARMS TABLET;ORAL 35MG A085497 Aug 19, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VIRTUS PHARMS TABLET;ORAL 35MG A086365 Sep 24, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A086403 Jan 15, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A086408 Jan 15, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A086410 Jan 15, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A087424 Jan 15, 1981

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A085634 Jun 05, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A085645 Jun 05, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE CAPSULE;ORAL 35MG A085670 Jun 09, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE TABLET;ORAL 35MG A086106 Feb 22, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE TABLET;ORAL 35MG A085519 Aug 19, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE VITARINE TABLET;ORAL 35MG A086005 Sep 11, 1978

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE WATSON LABS TABLET;ORAL 35MG A085767 Nov 28, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE WATSON LABS TABLET;ORAL 35MG A085768 Nov 28, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE WATSON LABS TABLET;ORAL 35MG A085770 Nov 28, 1977

PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE WATSON LABS TABLET;ORAL 35MG A085773 Nov 28, 1977

PHENDIMETRAZINE TARTRATE SPRX-105 NUMARK

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A088024 Dec 22, 1982

PHENDIMETRAZINE TARTRATE SPRX-3 SOLVAY CAPSULE;ORAL 35MG A085897 Oct 21, 1977

PHENDIMETRAZINE TARTRATE STATOBEX TEVA CAPSULE;ORAL 35MG A085507 Mar 09, 1978

PHENDIMETRAZINE TARTRATE STATOBEX TEVA TABLET;ORAL 35MG A086013 Dec 16, 1977

PHENDIMETRAZINE TARTRATE STATOBEX-G TEVA TABLET;ORAL 35MG A085095 Jun 22, 1977

PHENDIMETRAZINE TARTRATE X-TROZINE SHIRE RICHWOOD CAPSULE;ORAL 35MG A087394 Sep 22, 1982

PHENDIMETRAZINE TARTRATE X-TROZINE SHIRE RICHWOOD TABLET;ORAL 35MG A086550 Sep 16, 1981

PHENDIMETRAZINE TARTRATE X-TROZINE SHIRE RICHWOOD TABLET;ORAL 35MG A086551 Sep 16, 1981

PHENDIMETRAZINE TARTRATE X-TROZINE SHIRE RICHWOOD TABLET;ORAL 35MG A086552 Sep 16, 1981

PHENDIMETRAZINE TARTRATE X-TROZINE SHIRE RICHWOOD TABLET;ORAL 35MG A086553 Sep 16, 1981

PHENDIMETRAZINE TARTRATE X-TROZINE SHIRE RICHWOOD TABLET;ORAL 35MG A086554 Sep 16, 1981

PHENDIMETRAZINE TARTRATE X-TROZINE L.A. SHIRE RICHWOOD

CAPSULE, 

EXTENDED 

RELEASE;ORAL 105MG A087371 Aug 24, 1982

PHENTERMINE HYDROCHLORIDE OBESTIN-30 FERNDALE LABS CAPSULE;ORAL 30MG A087144 Apr 14, 1981

PHENTERMINE HYDROCHLORIDE OBY-TRIM SHIRE RICHWOOD CAPSULE;ORAL 30MG A087764 Mar 18, 1982

PHENTERMINE HYDROCHLORIDE ONA-MAST MAST MM CAPSULE;ORAL 30MG A086516 Apr 03, 1981

PHENTERMINE HYDROCHLORIDE ONA-MAST MAST MM CAPSULE;ORAL 30MG A086511 Sep 17, 1981

PHENTERMINE HYDROCHLORIDE ONA-MAST MAST MM TABLET;ORAL 8MG A086260 Mar 24, 1980

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE ABC HOLDING CAPSULE;ORAL 30MG A085411 Sep 10, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAMALL CAPSULE;ORAL 15MG A086735 Sep 10, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CAMALL CAPSULE;ORAL 30MG A087226 Sep 10, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 30MG A085417 Sep 10, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 30MG A086732 Sep 10, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 30MG A087215 Sep 10, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 37.5MG A087930 Oct 14, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 37.5MG A087918 Dec 22, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 37.5MG A087915 Dec 22, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 37.5MG A088610 Jun 04, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 37.5MG A088611 Jun 04, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 37.5MG A088625 Aug 23, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX CAPSULE;ORAL 18.75MG A088576 May 23, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 37.5MG A087805 Dec 06, 1982

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 37.5MG A088596 Apr 04, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 8MG A085319 Mar 14, 1977

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE CHARTWELL RX TABLET;ORAL 8MG A083923 Jul 01, 1976

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE IVAX PHARMS CAPSULE;ORAL 30MG A086329 Dec 08, 1978

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE IVAX PHARMS TABLET;ORAL 8MG A085553 Apr 11, 1978

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 30MG A087208 Jun 12, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 30MG A087223 Jun 12, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 37.5MG A088414 Oct 19, 1983

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ TABLET;ORAL 8MG A085671 Apr 28, 1978

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE SANDOZ TABLET;ORAL 8MG A085689 Apr 28, 1978

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TEVA CAPSULE;ORAL 30MG A086911 Jan 07, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TEVA CAPSULE;ORAL 30MG A087126 Oct 28, 1980

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TEVA CAPSULE;ORAL 30MG A088612 Apr 04, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TEVA CAPSULE;ORAL 30MG A088613 Apr 09, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE TEVA CAPSULE;ORAL 30MG A088614 Apr 09, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE UPSHER SMITH LABS CAPSULE;ORAL 30MG A088430 Mar 27, 1984

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE UPSHER SMITH LABS CAPSULE;ORAL 30MG A084487 Apr 09, 1982

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE USL PHARMA TABLET;ORAL 8MG A083804 Apr 05, 1978

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE VITARINE CAPSULE;ORAL 30MG A087235 Mar 06, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE VITARINE CAPSULE;ORAL 30MG A087202 Jun 12, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE VITARINE TABLET;ORAL 8MG A086453 Mar 19, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE VITARINE TABLET;ORAL 8MG A086456 Mar 19, 1981

PHENTERMINE HYDROCHLORIDE PHENTERMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 8MG A085739 May 19, 1978

PHENTERMINE HYDROCHLORIDE TORA SOLVAY TABLET;ORAL 8MG A084035 Feb 24, 1976

PHENYLBUTAZONE AZOLID SANOFI AVENTIS US CAPSULE;ORAL 100MG A087260 Oct 13, 1981

PHENYLBUTAZONE AZOLID SANOFI AVENTIS US TABLET;ORAL 100MG A087091 Jul 07, 1980

PHENYLBUTAZONE PHENYLBUTAZONE FOSUN PHARMA CAPSULE;ORAL 100MG A087774 Jun 16, 1982

PHENYLBUTAZONE PHENYLBUTAZONE FOSUN PHARMA TABLET;ORAL 100MG A084339 Jan 10, 1980

PHENYLBUTAZONE PHENYLBUTAZONE IVAX PHARMS CAPSULE;ORAL 100MG A088218 Jun 24, 1983

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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PHENYLBUTAZONE PHENYLBUTAZONE WATSON LABS CAPSULE;ORAL 100MG A087756 Dec 17, 1982

PHENYLBUTAZONE PHENYLBUTAZONE WATSON LABS TABLET;ORAL 100MG A086151 Oct 29, 1979

PHENYLBUTAZONE PHENYLBUTAZONE WATSON LABS TABLET;ORAL 100MG A087674 Apr 21, 1982

PHENYTOIN SODIUM DIPHENYLAN SODIUM LANNETT CAPSULE;ORAL 100MG PROMPT A080857 Dec 03, 1976

PHENYTOIN SODIUM DIPHENYLAN SODIUM LANNETT CAPSULE;ORAL 30MG PROMPT A080857 Dec 03, 1976

PHENYTOIN SODIUM PHENYTOIN SODIUM PHARMERAL CAPSULE;ORAL 100MG PROMPT A085435 Apr 15, 1977

PHENYTOIN SODIUM PHENYTOIN SODIUM WATSON LABS CAPSULE;ORAL 100MG PROMPT A085894 May 11, 1979

PHENYTOIN SODIUM PHENYTOIN SODIUM WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A085434 Oct 20, 1978

PHENYTOIN SODIUM PROMPT PHENYTOIN SODIUM ANI PHARMS CAPSULE;ORAL 100MG PROMPT A080259 Apr 06, 1978

PHENYTOIN SODIUM PROMPT PHENYTOIN SODIUM WATSON LABS CAPSULE;ORAL 100MG PROMPT A080905 Mar 03, 1978

PHYTONADIONE PHYTONADIONE GLAXOSMITHKLINE

INJECTABLE;INJE

CTION 10MG/ML A084060 Oct 31, 1974

PHYTONADIONE PHYTONADIONE GLAXOSMITHKLINE

INJECTABLE;INJE

CTION 1MG/0.5ML A084060 Oct 31, 1974

PHYTONADIONE VITAMIN K1 HOSPIRA

INJECTABLE;INJE

CTION 10MG/ML A087956 Jul 25, 1983

PIPERAZINE CITRATE PIPERAZINE CITRATE ALPHARMA US PHARMS SYRUP;ORAL

EQ 500MG 

BASE/5ML A080774 Jun 29, 1976

PIPERAZINE CITRATE PIPERAZINE CITRATE IMPAX LABS TABLET;ORAL EQ 250MG BASE A080874 Jul 19, 1973

PIPERAZINE CITRATE PIPERAZINE CITRATE LANNETT SYRUP;ORAL

EQ 500MG 

BASE/5ML A080963 Jul 25, 1974

PIPERAZINE CITRATE PIPERAZINE CITRATE LUITPOLD SYRUP;ORAL

EQ 500MG 

BASE/5ML A080671 Aug 02, 1972

PIPERAZINE CITRATE VERMIDOL SOLVAY SYRUP;ORAL

EQ 500MG 

BASE/5ML A080992 Nov 29, 1972

POTASSIUM AMINOSALICYLATE POTASSIUM AMINOSALICYLATE HEXCEL POWDER;ORAL 100% A080098 Apr 14, 1971

POTASSIUM CHLORIDE POTASSIUM CHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2MEQ/ML A084290 Oct 25, 1974

POTASSIUM CHLORIDE POTASSIUM CHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2MEQ/ML A087885 Feb 03, 1983

POTASSIUM CHLORIDE POTASSIUM CHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2MEQ/ML A087787 Apr 20, 1982

POTASSIUM CHLORIDE POTASSIUM CHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2MEQ/ML A080204 May 06, 1971

POTASSIUM CHLORIDE POTASSIUM CHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2MEQ/ML A086713 Aug 15, 1980

POTASSIUM CHLORIDE POTASSIUM CHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2MEQ/ML A086714 Aug 15, 1980

POTASSIUM CHLORIDE POTASSIUM CHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 2MEQ/ML A085499 Oct 13, 1977

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

POTASSIUM CHLORIDE POTASSIUM CHLORIDE BAXTER HLTHCARE

INJECTABLE;INJE

CTION 2MEQ/ML A080203 May 25, 1971

POTASSIUM CHLORIDE POTASSIUM CHLORIDE FRESENIUS KABI USA

INJECTABLE;INJE

CTION 2MEQ/ML A087817 Oct 20, 1982

POTASSIUM CHLORIDE POTASSIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 2MEQ/ML A086220 Jan 29, 1979

POTASSIUM CHLORIDE POTASSIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 2MEQ/ML A086219 May 31, 1979

POTASSIUM CHLORIDE POTASSIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 1MEQ/ML A086219 May 31, 1979

POTASSIUM CHLORIDE POTASSIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 3MEQ/ML A086220 Jan 30, 1979

POTASSIUM CHLORIDE POTASSIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 3MEQ/ML A086219 May 31, 1979

POTASSIUM CHLORIDE POTASSIUM CHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 4MEQ/ML A086219 May 31, 1979

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 2MEQ/ML A083345 Feb 13, 1974

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 1MEQ/ML A083345 Nov 18, 1977

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 1MEQ/ML A080205 Mar 16, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 1.5MEQ/ML A083345 Feb 13, 1974

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 2.4MEQ/ML A080205 Mar 16, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 3.2MEQ/ML A080205 Mar 16, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE INTL MEDICATION

INJECTABLE;INJE

CTION 2MEQ/ML A083163 Aug 29, 1975

POTASSIUM CHLORIDE POTASSIUM CHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 2MEQ/ML A080221 May 12, 1971

POTASSIUM CHLORIDE POTASSIUM CHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 2MEQ/ML A080736 Jun 27, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 2MEQ/ML A087584 Jun 30, 1981

POTASSIUM CHLORIDE POTASSIUM CHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 2MEQ/ML A087585 Jun 30, 1981

POTASSIUM CHLORIDE POTASSIUM CHLORIDE MILES

INJECTABLE;INJE

CTION 2MEQ/ML A080195 Mar 20, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE MILES

INJECTABLE;INJE

CTION 1MEQ/ML A080195 Mar 20, 1972

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

POTASSIUM CHLORIDE POTASSIUM CHLORIDE MILES

INJECTABLE;INJE

CTION 3MEQ/ML A080195 Mar 20, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE MILES

INJECTABLE;INJE

CTION 4MEQ/ML A080195 Mar 20, 1972

POTASSIUM CHLORIDE POTASSIUM CHLORIDE PHARMA SERVE NY

INJECTABLE;INJE

CTION 2MEQ/ML A087362 Mar 08, 1983

POTASSIUM CHLORIDE POTASSIUM CHLORIDE PHARMA SERVE NY

INJECTABLE;INJE

CTION 2MEQ/ML A086297 May 30, 1980

POTASSIUM CHLORIDE POTASSIUM CHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 2MEQ/ML A086208 Aug 14, 1981

POTASSIUM CHLORIDE POTASSIUM CHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 3MEQ/ML A086210 Nov 19, 1981

PREDNISOLONE CORTALONE HALSEY TABLET;ORAL 1MG A080304 Mar 16, 1972

PREDNISOLONE CORTALONE HALSEY TABLET;ORAL 2.5MG A080304 Mar 16, 1972

PREDNISOLONE CORTALONE HALSEY TABLET;ORAL 5MG A080304 Mar 16, 1972

PREDNISOLONE FERNISOLONE-P FERNDALE LABS TABLET;ORAL 5MG A083941 Aug 03, 1976

PREDNISOLONE PREDNISOLONE BARR TABLET;ORAL 5MG A084426 Dec 11, 1978

PREDNISOLONE PREDNISOLONE BUNDY TABLET;ORAL 5MG A083675 May 27, 1975

PREDNISOLONE PREDNISOLONE CHARTWELL RX TABLET;ORAL 5MG A084542 Nov 15, 1976

PREDNISOLONE PREDNISOLONE ELKINS SINN TABLET;ORAL 5MG A080625 Mar 29, 1972

PREDNISOLONE PREDNISOLONE EVERYLIFE TABLET;ORAL 5MG A084439 May 20, 1975

PREDNISOLONE PREDNISOLONE EVERYLIFE TABLET;ORAL 1MG A084439 May 20, 1975

PREDNISOLONE PREDNISOLONE EVERYLIFE TABLET;ORAL 2.5MG A084439 May 20, 1975

PREDNISOLONE PREDNISOLONE FERRANTE TABLET;ORAL 2.5MG A080562 May 09, 1972

PREDNISOLONE PREDNISOLONE FERRANTE TABLET;ORAL 5MG A080562 May 09, 1972

PREDNISOLONE PREDNISOLONE FOSUN PHARMA TABLET;ORAL 5MG A080339 Sep 06, 1972

PREDNISOLONE PREDNISOLONE HEATHER TABLET;ORAL 5MG A080326 May 29, 1974

PREDNISOLONE PREDNISOLONE IMPAX LABS TABLET;ORAL 5MG A080780 Jul 13, 1973

PREDNISOLONE PREDNISOLONE INWOOD LABS TABLET;ORAL 5MG A080748 Mar 24, 1972

PREDNISOLONE PREDNISOLONE IVAX SUB TEVA PHARMS TABLET;ORAL 5MG A080378 Dec 22, 1971

PREDNISOLONE PREDNISOLONE LANNETT TABLET;ORAL 5MG A080531 Jan 20, 1978

PREDNISOLONE PREDNISOLONE MARSHALL PHARMA TABLET;ORAL 5MG A080307 Apr 09, 1981

PREDNISOLONE PREDNISOLONE PANRAY TABLET;ORAL 1MG A080351 Nov 08, 1973

PREDNISOLONE PREDNISOLONE PANRAY TABLET;ORAL 5MG A080351 Nov 08, 1973

PREDNISOLONE PREDNISOLONE PHOENIX LABS NY TABLET;ORAL 5MG A080322 Oct 15, 1975

PREDNISOLONE PREDNISOLONE PUREPAC PHARM TABLET;ORAL 5MG A080325 Mar 30, 1972

PREDNISOLONE PREDNISOLONE PVT FORM TABLET;ORAL 5MG A080211 May 04, 1972

PREDNISOLONE PREDNISOLONE RISING TABLET;ORAL 5MG A084773 Nov 11, 1975

PREDNISOLONE PREDNISOLONE ROXANE TABLET;ORAL 5MG A080327 Apr 30, 1973

PREDNISOLONE PREDNISOLONE SPERTI TABLET;ORAL 2.5MG A080358 May 01, 1973

PREDNISOLONE PREDNISOLONE SPERTI TABLET;ORAL 1MG A080358 May 01, 1973

PREDNISOLONE PREDNISOLONE SPERTI TABLET;ORAL 5MG A080358 May 01, 1973

PREDNISOLONE PREDNISOLONE TABLICAPS TABLET;ORAL 5MG A085170 Feb 09, 1977

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PREDNISOLONE PREDNISOLONE TEVA TABLET;ORAL 5MG A080398 Sep 02, 1971

PREDNISOLONE PREDNISOLONE UDL TABLET;ORAL 5MG A087987 Jan 18, 1983

PREDNISOLONE PREDNISOLONE VALEANT PHARM INTL TABLET;ORAL 5MG A080236 Jan 31, 1972

PREDNISOLONE PREDNISOLONE VITARINE TABLET;ORAL 5MG A080534 May 31, 1974

PREDNISOLONE PREDNISOLONE WATSON LABS TABLET;ORAL 5MG A085416 Mar 11, 1977

PREDNISOLONE PREDNISOLONE WATSON LABS TABLET;ORAL 5MG A085415 Mar 14, 1977

PREDNISOLONE PREDNISOLONE WATSON LABS TABLET;ORAL 5MG A085085 Feb 23, 1977

PREDNISOLONE PREDNISOLONE WEST WARD TABLET;ORAL 5MG A080324 Apr 21, 1972

PREDNISOLONE PREDNISOLONE WHITEWORTH TOWN PLSN TABLET;ORAL 5MG A080342 Jun 20, 1973

PREDNISOLONE ACETATE PREDNISOLONE ACETATE AKORN

INJECTABLE;INJE

CTION 25MG/ML A083032 Mar 29, 1974

PREDNISOLONE ACETATE PREDNISOLONE ACETATE AKORN

INJECTABLE;INJE

CTION 50MG/ML A084492 Jun 12, 1975

PREDNISOLONE ACETATE PREDNISOLONE ACETATE BEL MAR

INJECTABLE;INJE

CTION 25MG/ML A083738 Mar 06, 1974

PREDNISOLONE ACETATE PREDNISOLONE ACETATE BEL MAR

INJECTABLE;INJE

CTION 50MG/ML A083738 Mar 06, 1974

PREDNISOLONE ACETATE PREDNISOLONE ACETATE CENT PHARMS

INJECTABLE;INJE

CTION 25MG/ML A084717 Mar 17, 1978

PREDNISOLONE ACETATE PREDNISOLONE ACETATE CENT PHARMS

INJECTABLE;INJE

CTION 50MG/ML A084717 Mar 17, 1978

PREDNISOLONE ACETATE PREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A083654 Nov 15, 1977

PREDNISOLONE ACETATE PREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A083398 Feb 13, 1974

PREDNISOLONE ACETATE PREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 40MG/ML A083767 Feb 13, 1974

PREDNISOLONE ACETATE PREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A085781 Dec 08, 1977

PREDNISOLONE ACETATE PREDNISOLONE ACETATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A083764 Feb 13, 1974

PREDNISOLONE ACETATE; 

SULFACETAMIDE SODIUM ISOPTO CETAPRED ALCON

SUSPENSION;OPHT

HALMIC 0.25%;10% A087547 Jul 21, 1981

PREDNISOLONE ACETATE; 

SULFACETAMIDE SODIUM PREDAMIDE AKORN

SUSPENSION/DROP

S;OPHTHALMIC 0.5%;10% A088059 Jul 29, 1983

PREDNISOLONE ACETATE; 

SULFACETAMIDE SODIUM PREDSULFAIR PHARMAFAIR

OINTMENT;OPHTHA

LMIC 0.5%;10% A088032 Apr 15, 1983

PREDNISOLONE ACETATE; 

SULFACETAMIDE SODIUM PREDSULFAIR PHARMAFAIR

SUSPENSION/DROP

S;OPHTHALMIC 0.5%;10% A088007 Apr 19, 1983

PREDNISOLONE ACETATE; 

SULFACETAMIDE SODIUM SULPHRIN BAUSCH AND LOMB

SUSPENSION/DROP

S;OPHTHALMIC 0.5%;10% A088089 Dec 28, 1982

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PREDNISOLONE SODIUM 

PHOSPHATE INFLAMASE FORTE NOVARTIS

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.9% 

PHOSPHATE A080751 Dec 19, 1973

PREDNISOLONE SODIUM 

PHOSPHATE INFLAMASE MILD NOVARTIS

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.11% 

PHOSPHATE A080751 Dec 19, 1973

PREDNISOLONE SODIUM 

PHOSPHATE METRETON SCHERING

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.5% 

PHOSPHATE A083834 Mar 13, 1980

PREDNISOLONE SODIUM 

PHOSPHATE PREDAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.11% 

PHOSPHATE A088415 Feb 29, 1984

PREDNISOLONE SODIUM 

PHOSPHATE PREDAIR FORTE PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.9% 

PHOSPHATE A088165 Mar 28, 1983

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE AKORN

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.11% 

PHOSPHATE A083358 Aug 21, 1974

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE AKORN

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.9% 

PHOSPHATE A083358 Aug 21, 1974

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.11% 

PHOSPHATE A084171 Nov 29, 1974

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.9% 

PHOSPHATE A084169 Nov 22, 1974

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.9% 

PHOSPHATE A084172 Nov 22, 1974

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC

EQ 0.9% 

PHOSPHATE A084168 Dec 02, 1974

PREDNISOLONE SODIUM 

PHOSPHATE

PREDNISOLONE SODIUM 

PHOSPHATE WATSON LABS

INJECTABLE;INJE

CTION

EQ 20MG 

PHOSPHATE/ML A080517 Jan 29, 1974

PREDNISOLONE TEBUTATE PREDNISOLONE TEBUTATE WATSON LABS

INJECTABLE;INJE

CTION 20MG/ML A083362 Feb 17, 1984

PREDNISONE CORTAN HALSEY TABLET;ORAL 20MG A087480 Jul 28, 1981

PREDNISONE DELTA-DOME BAYER PHARMS TABLET;ORAL 5MG A080293 Apr 17, 1972

PREDNISONE FERNISONE FERNDALE LABS TABLET;ORAL 5MG A083364 May 14, 1974

PREDNISONE LIQUID PRED MURO SYRUP;ORAL 5MG/5ML A087611 Sep 07, 1982

PREDNISONE ORASONE SOLVAY TABLET;ORAL 10MG A083009 Jan 29, 1974

PREDNISONE ORASONE SOLVAY TABLET;ORAL 5MG A083009 Jan 29, 1974

PREDNISONE ORASONE SOLVAY TABLET;ORAL 1MG A083009 Jan 29, 1974

PREDNISONE ORASONE SOLVAY TABLET;ORAL 20MG A083009 Jan 29, 1974

PREDNISONE ORASONE SOLVAY TABLET;ORAL 50MG A085999 Mar 03, 1978

PREDNISONE PREDNICEN-M SCHWARZ PHARMA TABLET;ORAL 5MG A084655 Dec 09, 1975

PREDNISONE PREDNISONE BUNDY TABLET;ORAL 5MG A083676 Jul 12, 1976

PREDNISONE PREDNISONE CHARTWELL RX TABLET;ORAL 5MG A083059 Nov 19, 1974

PREDNISONE PREDNISONE CONTRACT PHARMACAL TABLET;ORAL 5MG A080209 Jul 05, 1972

PREDNISONE PREDNISONE DURAMED PHARMS BARR TABLET;ORAL 10MG A088395 Oct 04, 1983

PREDNISONE PREDNISONE DURAMED PHARMS BARR TABLET;ORAL 5MG A088394 Oct 04, 1983

PREDNISONE PREDNISONE DURAMED PHARMS BARR TABLET;ORAL 20MG A088396 Oct 04, 1983

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PREDNISONE PREDNISONE ELKINS SINN TABLET;ORAL 5MG A080491 Oct 29, 1971

PREDNISONE PREDNISONE ELKINS SINN TABLET;ORAL 20MG A085811 Dec 20, 1977

PREDNISONE PREDNISONE EVERYLIFE TABLET;ORAL 1MG A084440 Feb 25, 1975

PREDNISONE PREDNISONE EVERYLIFE TABLET;ORAL 2.5MG A084440 Feb 25, 1975

PREDNISONE PREDNISONE EVERYLIFE TABLET;ORAL 5MG A084440 Feb 25, 1975

PREDNISONE PREDNISONE FERRANTE TABLET;ORAL 5MG A080563 Apr 21, 1972

PREDNISONE PREDNISONE FERRANTE TABLET;ORAL 2.5MG A080563 Apr 21, 1972

PREDNISONE PREDNISONE HALSEY TABLET;ORAL 5MG A080300 Jun 03, 1971

PREDNISONE PREDNISONE HEATHER TABLET;ORAL 10MG A084341 May 14, 1975

PREDNISONE PREDNISONE HEATHER TABLET;ORAL 5MG A080320 Mar 21, 1974

PREDNISONE PREDNISONE HEATHER TABLET;ORAL 20MG A084417 Dec 11, 1974

PREDNISONE PREDNISONE HEATHER TABLET;ORAL 20MG A085543 Mar 14, 1977

PREDNISONE PREDNISONE HEATHER TABLET;ORAL 50MG A086946 Oct 09, 1980

PREDNISONE PREDNISONE HIKMA PHARMS TABLET;ORAL 50MG A088465 Jun 01, 1984

PREDNISONE PREDNISONE IMPAX LABS TABLET;ORAL 5MG A080782 Aug 01, 1973

PREDNISONE PREDNISONE INWOOD LABS TABLET;ORAL 5MG A080279 Dec 23, 1971

PREDNISONE PREDNISONE INWOOD LABS TABLET;ORAL 1MG A080328 Jul 13, 1972

PREDNISONE PREDNISONE INWOOD LABS TABLET;ORAL 2.5MG A080306 Dec 23, 1971

PREDNISONE PREDNISONE IVAX SUB TEVA PHARMS TABLET;ORAL 10MG A084133 Mar 06, 1974

PREDNISONE PREDNISONE IVAX SUB TEVA PHARMS TABLET;ORAL 5MG A080283 Nov 16, 1971

PREDNISONE PREDNISONE IVAX SUB TEVA PHARMS TABLET;ORAL 20MG A084134 Mar 06, 1974

PREDNISONE PREDNISONE KV PHARM TABLET;ORAL 5MG A084236 Jul 25, 1975

PREDNISONE PREDNISONE LANNETT TABLET;ORAL 20MG A084275 Jun 27, 1974

PREDNISONE PREDNISONE LANNETT TABLET;ORAL 5MG A080514 May 02, 1974

PREDNISONE PREDNISONE LEDERLE TABLET;ORAL 5MG A086968 Sep 26, 1979

PREDNISONE PREDNISONE MARSHALL PHARMA TABLET;ORAL 5MG A080301 Apr 09, 1981

PREDNISONE PREDNISONE MUTUAL PHARM TABLET;ORAL 10MG A086595 Apr 10, 1979

PREDNISONE PREDNISONE MUTUAL PHARM TABLET;ORAL 5MG A080701 Nov 14, 1972

PREDNISONE PREDNISONE MUTUAL PHARM TABLET;ORAL 20MG A084634 Oct 21, 1975

PREDNISONE PREDNISONE NYLOS TABLET;ORAL 5MG A085115 Jul 30, 1976

PREDNISONE PREDNISONE PANRAY TABLET;ORAL 5MG A080350 Nov 08, 1973

PREDNISONE PREDNISONE PANRAY TABLET;ORAL 1MG A080350 Nov 08, 1973

PREDNISONE PREDNISONE PANRAY TABLET;ORAL 2.5MG A080350 Nov 08, 1973

PREDNISONE PREDNISONE PHARMAVITE TABLET;ORAL 5MG A084662 Dec 01, 1976

PREDNISONE PREDNISONE PHOENIX LABS NY TABLET;ORAL 5MG A080321 Dec 11, 1975

PREDNISONE PREDNISONE PHOENIX LABS NY TABLET;ORAL 20MG A083807 Nov 26, 1974

PREDNISONE PREDNISONE PUREPAC PHARM TABLET;ORAL 10MG A086062 Feb 08, 1979

PREDNISONE PREDNISONE PUREPAC PHARM TABLET;ORAL 5MG A080353 Apr 24, 1972

PREDNISONE PREDNISONE PUREPAC PHARM TABLET;ORAL 20MG A086061 Feb 08, 1979

PREDNISONE PREDNISONE PVT FORM TABLET;ORAL 20MG A085151 Aug 26, 1976

PREDNISONE PREDNISONE REXALL TABLET;ORAL 5MG A080232 Jun 21, 1972

PREDNISONE PREDNISONE RISING TABLET;ORAL 5MG A084774 Nov 11, 1975

PREDNISONE PREDNISONE RISING TABLET;ORAL 20MG A085813 May 31, 1978

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PREDNISONE PREDNISONE ROXANE TABLET;ORAL 25MG A087833 May 04, 1982

PREDNISONE PREDNISONE SANDOZ TABLET;ORAL 5MG A080336 Jul 29, 1976

PREDNISONE PREDNISONE SCHERER LABS TABLET;ORAL 5MG A080371 Dec 22, 1971

PREDNISONE PREDNISONE SPERTI TABLET;ORAL 5MG A080359 May 01, 1973

PREDNISONE PREDNISONE SPERTI TABLET;ORAL 1MG A080359 May 01, 1973

PREDNISONE PREDNISONE SPERTI TABLET;ORAL 2.5MG A080359 May 01, 1973

PREDNISONE PREDNISONE SUN PHARM INDUSTRIES TABLET;ORAL 50MG A086596 Apr 10, 1979

PREDNISONE PREDNISONE TEVA TABLET;ORAL 5MG A080397 Sep 02, 1971

PREDNISONE PREDNISONE UDL TABLET;ORAL 10MG A087985 Jan 18, 1983

PREDNISONE PREDNISONE UDL TABLET;ORAL 5MG A087984 Jan 18, 1983

PREDNISONE PREDNISONE UDL TABLET;ORAL 20MG A087986 Jan 18, 1983

PREDNISONE PREDNISONE UPSHER SMITH TABLET;ORAL 5MG A087471 Oct 23, 1981

PREDNISONE PREDNISONE UPSHER SMITH TABLET;ORAL 20MG A087470 Oct 23, 1981

PREDNISONE PREDNISONE VALEANT PHARM INTL TABLET;ORAL 5MG A080237 Jan 24, 1972

PREDNISONE PREDNISONE VANGARD TABLET;ORAL 5MG A087682 Jan 15, 1982

PREDNISONE PREDNISONE VANGARD TABLET;ORAL 20MG A087701 Jan 15, 1982

PREDNISONE PREDNISONE VITARINE TABLET;ORAL 5MG A080506 Jan 22, 1975

PREDNISONE PREDNISONE VITARINE TABLET;ORAL 5MG A080334 Mar 06, 1972

PREDNISONE PREDNISONE WATSON LABS TABLET;ORAL 10MG A087773 Jul 13, 1982

PREDNISONE PREDNISONE WATSON LABS TABLET;ORAL 5MG A085084 Dec 15, 1981

PREDNISONE PREDNISONE WATSON LABS TABLET;ORAL 20MG A086813 Jun 01, 1979

PREDNISONE PREDNISONE WATSON LABS TABLET;ORAL 50MG A086867 Oct 09, 1980

PREDNISONE PREDNISONE WATSON LABS TABLET;ORAL 50MG A087772 Jul 13, 1982

PREDNISONE PREDNISONE WHITEWORTH TOWN PLSN TABLET;ORAL 5MG A080343 Jun 20, 1973

PREDNISONE PREDNISONE WHITEWORTH TOWN PLSN TABLET;ORAL 2.5MG A084913 Jul 17, 1978

PREDNISONE PREDNISONE WHITEWORTH TOWN PLSN TABLET;ORAL 20MG A084913 Jul 17, 1978

PREDNISONE SERVISONE LEDERLE TABLET;ORAL 5MG A080223 Dec 27, 1971

PRIMIDONE PRIMIDONE WATSON LABS TABLET;ORAL 250MG A085052 Mar 21, 1979

PROBENECID PROBENECID IVAX SUB TEVA PHARMS TABLET;ORAL 500MG A083740 May 09, 1984

PROBENECID PROBENECID LEDERLE TABLET;ORAL 500MG A086917 Oct 09, 1979

PROBENECID PROBENECID WATSON LABS TABLET;ORAL 500MG A086150 Apr 23, 1982

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE ASCOT CAPSULE;ORAL 250MG A087542 Jan 08, 1982

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE ASCOT CAPSULE;ORAL 375MG A087697 Mar 01, 1983

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE ASCOT CAPSULE;ORAL 500MG A087543 Jan 08, 1982

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE INTL MEDICATION

INJECTABLE;INJE

CTION 500MG/ML A088637 Jul 31, 1984

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 250MG A084604 Dec 02, 1976

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 375MG A084595 Jun 14, 1977

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 500MG A084606 Jun 14, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE LANNETT CAPSULE;ORAL 250MG A083693 May 11, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE LANNETT CAPSULE;ORAL 500MG A084696 May 11, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE LEDERLE CAPSULE;ORAL 250MG A086942 Aug 31, 1979

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE LEDERLE CAPSULE;ORAL 375MG A086952 Sep 05, 1979

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE LEDERLE CAPSULE;ORAL 500MG A086943 Sep 05, 1979

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE VANGARD CAPSULE;ORAL 250MG A087643 Jun 01, 1982

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE VANGARD CAPSULE;ORAL 500MG A087875 Jun 01, 1982

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 250MG A083795 Jun 02, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 250MG A083287 Jun 03, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 250MG A085167 Jul 17, 1980

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 375MG A084403 Jun 03, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 375MG A087020 Jul 17, 1980

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 500MG A084357 May 23, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 500MG A084280 Jun 07, 1977

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 500MG A087021 Jul 17, 1980

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A087079 Nov 02, 1981

PROCAINAMIDE HYDROCHLORIDE PROCAINAMIDE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 500MG/ML A087080 Nov 02, 1981

PROCAINAMIDE HYDROCHLORIDE PROCAN PARKE DAVIS CAPSULE;ORAL 250MG A085804 Jan 28, 1980

PROCAINAMIDE HYDROCHLORIDE PROCAN PARKE DAVIS CAPSULE;ORAL 375MG A087502 Dec 01, 1981

PROCAINAMIDE HYDROCHLORIDE PROCAN PARKE DAVIS CAPSULE;ORAL 500MG A085079 Jan 28, 1980

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROCAINAMIDE HYDROCHLORIDE PROCAN SR PARKE DAVIS

TABLET, 

EXTENDED 

RELEASE;ORAL 250MG A086468 Dec 11, 1979

PROCAINAMIDE HYDROCHLORIDE PROCAN SR PARKEDALE

TABLET, 

EXTENDED 

RELEASE;ORAL 500MG A086065 Dec 11, 1979

PROCAINAMIDE HYDROCHLORIDE PROCAN SR PARKEDALE

TABLET, 

EXTENDED 

RELEASE;ORAL 750MG A087510 Apr 01, 1982

PROCAINAMIDE HYDROCHLORIDE PROCAPAN PANRAY CAPSULE;ORAL 250MG A083553 Mar 25, 1975

PROCAINAMIDE HYDROCHLORIDE PRONESTYL-SR APOTHECON

TABLET, 

EXTENDED 

RELEASE;ORAL 500MG A087361 Aug 12, 1981

PROCAINE HYDROCHLORIDE NOVOCAIN HOSPIRA

INJECTABLE;INJE

CTION 1% A085362 Nov 15, 1979

PROCAINE HYDROCHLORIDE NOVOCAIN HOSPIRA

INJECTABLE;INJE

CTION 2% A085362 Nov 15, 1979

PROCAINE HYDROCHLORIDE NOVOCAIN HOSPIRA

INJECTABLE;INJE

CTION 10% A086797 Jul 10, 1979

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 1% A080421 Dec 08, 1972

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 1% A080384 Mar 06, 1972

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2% A080421 Dec 08, 1972

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 2% A080384 Mar 06, 1972

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 1% A080711 Dec 03, 1973

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 2% A080756 Dec 03, 1973

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE ELKINS SINN

INJECTABLE;INJE

CTION 1% A083315 Oct 12, 1973

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE ELKINS SINN

INJECTABLE;INJE

CTION 2% A083315 Oct 12, 1973

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 1% A086202 Jan 30, 1979

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE GD SEARLE LLC

INJECTABLE;INJE

CTION 2% A086202 Jan 29, 1979

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 1% A080416 Sep 15, 1972

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 2% A080416 Sep 15, 1972

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE MILES

INJECTABLE;INJE

CTION 1% A080415 Nov 22, 1974

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE MILES

INJECTABLE;INJE

CTION 2% A080415 Nov 22, 1974

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 1% A080658 Apr 01, 1974

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 1% A083535 Aug 01, 1977

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 2% A080658 Apr 01, 1974

PROCAINE HYDROCHLORIDE PROCAINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 2% A083535 Aug 01, 1977

PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE ALPHARMA US PHARMS

CONCENTRATE;ORA

L

EQ 10MG 

BASE/ML A087153 Jun 08, 1982

PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE BAXTER HLTHCARE

INJECTABLE;INJE

CTION EQ 5MG BASE/ML A087759 Oct 01, 1982

PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE ALPHARMA US PHARMS SYRUP;ORAL

EQ 5MG 

BASE/5ML A087154 Sep 01, 1982

PROCHLORPERAZINE EDISYLATE PROCHLORPERAZINE EDISYLATE WYETH AYERST

INJECTABLE;INJE

CTION EQ 5MG BASE/ML A086348 Jul 05, 1979

PROCHLORPERAZINE MALEATE PROCHLORPERAZINE WATSON LABS TABLET;ORAL EQ 10MG BASE A085178 Aug 21, 1978

PROCHLORPERAZINE MALEATE PROCHLORPERAZINE WATSON LABS TABLET;ORAL EQ 25MG BASE A085579 Aug 21, 1978

PROCHLORPERAZINE MALEATE PROCHLORPERAZINE WATSON LABS TABLET;ORAL EQ 5MG BASE A085580 Aug 21, 1978

PROMAZINE HYDROCHLORIDE PROMAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A084510 Mar 08, 1979

PROMAZINE HYDROCHLORIDE PROMAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A084517 Feb 27, 1979

PROMETHAZINE HYDROCHLORIDE MYMETHAZINE FORTIS USL PHARMA SYRUP;ORAL 25MG/5ML A087996 Jan 18, 1983

PROMETHAZINE HYDROCHLORIDE PROMETH FORTIS ALPHARMA US PHARMS SYRUP;ORAL 25MG/5ML A084772 Nov 14, 1978

PROMETHAZINE HYDROCHLORIDE PROMETH PLAIN ACTAVIS MID ATLANTIC SYRUP;ORAL 6.25MG/5ML A085953 Aug 21, 1978

PROMETHAZINE HYDROCHLORIDE PROMETHACON POLYMEDICA

SUPPOSITORY;REC

TAL 25MG A084901 Oct 05, 1981

PROMETHAZINE HYDROCHLORIDE PROMETHACON POLYMEDICA

SUPPOSITORY;REC

TAL 50MG A084902 Oct 05, 1981

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 25MG/ML A084223 Jan 20, 1975

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NUMBER

APPROVAL DATE

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE ABBOTT

INJECTABLE;INJE

CTION 50MG/ML A084222 Sep 16, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 12.5MG A084160 May 16, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 25MG A084166 Nov 01, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE ABBOTT TABLET;ORAL 50MG A084539 Oct 08, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AKORN

INJECTABLE;INJE

CTION 25MG/ML A083955 Jul 09, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE AKORN

INJECTABLE;INJE

CTION 50MG/ML A083955 Jul 09, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE HOSPIRA

INJECTABLE;INJE

CTION 50MG/ML A083838 Jan 21, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE IMPAX LABS TABLET;ORAL 25MG A084214 Jul 07, 1982

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INVATECH TABLET;ORAL 12.5MG A084233 Jan 15, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INVATECH TABLET;ORAL 25MG A085146 Aug 06, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE INVATECH TABLET;ORAL 50MG A085146 Aug 06, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 12.5MG A083604 Sep 17, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 25MG A083603 Oct 26, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE IVAX SUB TEVA PHARMS TABLET;ORAL 50MG A083613 Sep 21, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE KV PHARM SYRUP;ORAL 6.25MG/5ML A085388 May 16, 1977

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE KV PHARM SYRUP;ORAL 25MG/5ML A085385 Mar 03, 1977

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE LANNETT TABLET;ORAL 12.5MG A080949 Jul 28, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE LANNETT TABLET;ORAL 25MG A080949 Jun 28, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE LANNETT TABLET;ORAL 50MG A080949 Jun 28, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE PHARM ASSOC SYRUP;ORAL 6.25MG/5ML A087518 Oct 09, 1981

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE PVT FORM TABLET;ORAL 12.5MG A083214 Sep 09, 1976

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE PVT FORM TABLET;ORAL 25MG A083658 Oct 01, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 12.5MG A084555 Jul 29, 1976

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 25MG A084554 Jul 29, 1975

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 50MG A084557 Jul 29, 1975

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLICAPS TABLET;ORAL 12.5MG A084080 Mar 18, 1975

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLICAPS TABLET;ORAL 25MG A084027 Jul 25, 1975

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A083532 Oct 28, 1977

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A084591 Sep 15, 1978

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A080629 Jan 29, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A083532 Oct 28, 1977

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 12.5MG A083401 Oct 25, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 12.5MG A083712 Sep 21, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 12.5MG A085986 Sep 29, 1978

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A083204 Mar 06, 1973

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A085684 Sep 26, 1977

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A083403 Nov 01, 1974

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085664 Sep 26, 1977

PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE WHITEWORTH TOWN PLSN SYRUP;ORAL 6.25MG/5ML A086395 Jun 05, 1979

PROMETHAZINE HYDROCHLORIDE REMSED BRISTOL MYERS SQUIBB TABLET;ORAL 25MG A083176 Sep 15, 1972

PROMETHAZINE HYDROCHLORIDE REMSED BRISTOL MYERS SQUIBB TABLET;ORAL 50MG A083176 Sep 15, 1972

PROMETHAZINE HYDROCHLORIDE ZIPAN-25 ALTANA

INJECTABLE;INJE

CTION 25MG/ML A083997 Nov 21, 1978

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROMETHAZINE HYDROCHLORIDE ZIPAN-50 ALTANA

INJECTABLE;INJE

CTION 50MG/ML A083997 Nov 21, 1978

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE ASCOT TABLET;ORAL 15MG A087663 Oct 25, 1982

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE HEATHER TABLET;ORAL 15MG A085780 Oct 26, 1977

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE HIKMA TABLET;ORAL 15MG A080927 Sep 09, 1974

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE HIKMA TABLET;ORAL 7.5MG A080927 Sep 09, 1974

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE IMPAX LABS TABLET;ORAL 15MG A084541 Jul 26, 1976

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE MYLAN TABLET;ORAL 15MG A083706 May 13, 1975

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE PAR PHARM TABLET;ORAL 15MG A088377 Dec 08, 1983

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE PVT FORM TABLET;ORAL 15MG A080977 Aug 04, 1976

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE SANDOZ TABLET;ORAL 15MG A080928 Dec 19, 1975

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE TABLICAPS TABLET;ORAL 15MG A084428 Jul 28, 1975

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE WATSON LABS TABLET;ORAL 15MG A083151 May 09, 1975

PROPANTHELINE BROMIDE PROPANTHELINE BROMIDE WATSON LABS TABLET;ORAL 15MG A083029 Jul 25, 1977

PROPARACAINE HYDROCHLORIDE KAINAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 0.5% A088087 Jun 07, 1983

PROPARACAINE HYDROCHLORIDE PARACAINE OPTOPICS

SOLUTION/DROPS;

OPHTHALMIC 0.5% A087681 Aug 05, 1982

PROPARACAINE HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 0.5% A084144 Nov 01, 1974

PROPARACAINE HYDROCHLORIDE PROPARACAINE HYDROCHLORIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 0.5% A084151 Dec 19, 1974

PROPOXYPHENE HYDROCHLORIDE DOLENE HERITAGE PHARMS INC CAPSULE;ORAL 65MG A080530 Sep 15, 1972

PROPOXYPHENE HYDROCHLORIDE KESSO-GESIC MK LABS CAPSULE;ORAL 65MG A083544 Jun 06, 1973

PROPOXYPHENE HYDROCHLORIDE PROPHENE 65 HALSEY CAPSULE;ORAL 65MG A083538 Jun 26, 1981

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE ALRA CAPSULE;ORAL 65MG A083184 Sep 06, 1972

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE IMPAX LABS CAPSULE;ORAL 65MG A083317 Oct 23, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE IVAX SUB TEVA PHARMS CAPSULE;ORAL 32MG A083597 Dec 11, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE MUTUAL PHARM CAPSULE;ORAL 65MG A083186 Dec 18, 1972

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE MYLAN CAPSULE;ORAL 32MG A083528 Aug 07, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE MYLAN CAPSULE;ORAL 65MG A083299 Jan 17, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE NEXGEN PHARMA INC CAPSULE;ORAL 65MG A083185 Nov 02, 1972

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE PAR PHARM CAPSULE;ORAL 65MG A080269 Nov 30, 1971

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE PUREPAC PHARM CAPSULE;ORAL 65MG A083278 Jan 15, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE PVT FORM CAPSULE;ORAL 32MG A083464 Aug 20, 1976

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE PVT FORM CAPSULE;ORAL 65MG A083113 Aug 20, 1976

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE ROXANE CAPSULE;ORAL 32MG A083089 Aug 13, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE ROXANE CAPSULE;ORAL 65MG A083089 Aug 13, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 32MG A084014 Sep 09, 1974

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 65MG A083688 Feb 13, 1975

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 65MG A083125 Apr 14, 1976

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 65MG A086495 Jul 07, 1980

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE SANDOZ CAPSULE;ORAL 65MG A083870 Aug 27, 1974

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE VALEANT PHARM INTL CAPSULE;ORAL 65MG A080783 Jan 29, 1974

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 65MG A085190 Nov 08, 1976

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE WATSON LABS CAPSULE;ORAL 65MG A080908 Aug 07, 1972

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE WEST WARD CAPSULE;ORAL 65MG A083501 Jun 20, 1973

PROPOXYPHENE HYDROCHLORIDE PROPOXYPHENE HYDROCHLORIDE WHITEWORTH TOWN PLSN CAPSULE;ORAL 65MG A084551 Apr 21, 1978

PROPOXYPHENE HYDROCHLORIDE

PROPOXYPHENE HYDROCHLORIDE 

65 WARNER CHILCOTT CAPSULE;ORAL 65MG A083786 Feb 13, 1974

PROPYLTHIOURACIL PROPYLTHIOURACIL ABBOTT TABLET;ORAL 50MG A084075 Apr 30, 1974

PROPYLTHIOURACIL PROPYLTHIOURACIL ANABOLIC TABLET;ORAL 50MG A080285 Dec 19, 1974

PROPYLTHIOURACIL PROPYLTHIOURACIL ANI PHARMS TABLET;ORAL 50MG A080215 Aug 19, 1971

PROPYLTHIOURACIL PROPYLTHIOURACIL CHARTWELL RX TABLET;ORAL 50MG A084543 Feb 15, 1977

PROPYLTHIOURACIL PROPYLTHIOURACIL HALSEY TABLET;ORAL 50MG A080015 Oct 16, 1970

PROPYLTHIOURACIL PROPYLTHIOURACIL IMPAX LABS TABLET;ORAL 50MG A080159 Aug 10, 1973

PROPYLTHIOURACIL PROPYLTHIOURACIL LANNETT TABLET;ORAL 50MG A080016 Jul 24, 1970

PROPYLTHIOURACIL PROPYLTHIOURACIL SUN PHARM INDUSTRIES TABLET;ORAL 50MG A083982 May 06, 1974

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

PROPYLTHIOURACIL PROPYLTHIOURACIL TABLICAPS TABLET;ORAL 50MG A080840 Jun 06, 1973

PROPYLTHIOURACIL PROPYLTHIOURACIL WATSON LABS TABLET;ORAL 50MG A080932 Jan 17, 1973

PROPYLTHIOURACIL PROPYLTHIOURACIL WATSON LABS TABLET;ORAL 50MG A085201 Mar 03, 1977

PROTOKYLOL HYDROCHLORIDE VENTAIRE SANOFI AVENTIS US TABLET;ORAL 2MG A083459 Dec 03, 1973

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE ACTAHIST CENCI SYRUP;ORAL

30MG/5ML;1.25M

G/5ML A088344 Feb 09, 1984

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE HISTAFED CENCI SYRUP;ORAL

30MG/5ML;1.25M

G/5ML A088283 Apr 20, 1984

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE MYFED USL PHARMA SYRUP;ORAL

30MG/5ML;1.25M

G/5ML A088116 Mar 04, 1983

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE

PSEUDOEPHEDRINE 

HYDROCHLORIDE AND 

TRIPROLIDINE HYDROCHLORIDE SANDOZ TABLET;ORAL 60MG;2.5MG A088193 May 17, 1983

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE TRIPHED TEVA TABLET;ORAL 60MG;2.5MG A088630 May 17, 1984

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE

TRIPROLIDINE AND 

PSEUDOEPHEDRINE WATSON LABS TABLET;ORAL 60MG;2.5MG A088318 Jan 13, 1984

PSEUDOEPHEDRINE 

HYDROCHLORIDE; TRIPROLIDINE 

HYDROCHLORIDE

TRIPROLIDINE AND 

PSEUDOEPHEDRINE WEST WARD TABLET;ORAL 60MG;2.5MG A088117 Apr 19, 1983

PYRIDOXINE HYDROCHLORIDE HEXA-BETALIN LILLY

INJECTABLE;INJE

CTION 100MG/ML A080854 Jun 22, 1973

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE AKORN

INJECTABLE;INJE

CTION 100MG/ML A087967 Oct 01, 1982

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 100MG/ML A080761 Dec 11, 1973

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE DELL LABS

INJECTABLE;INJE

CTION 100MG/ML A083772 Oct 22, 1974

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE DELL LABS

INJECTABLE;INJE

CTION 50MG/ML A083771 Mar 18, 1975

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NUMBER

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PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 100MG/ML A080572 Feb 13, 1974

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE ELKINS SINN

INJECTABLE;INJE

CTION 100MG/ML A080581 Nov 14, 1972

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 100MG/ML A080669 Mar 30, 1972

PYRIDOXINE HYDROCHLORIDE PYRIDOXINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A083760 Jul 01, 1977

PYRILAMINE MALEATE PYRILAMINE MALEATE IMPAX LABS TABLET;ORAL 25MG A080808 Aug 07, 1973

PYRILAMINE MALEATE PYRILAMINE MALEATE WATSON LABS TABLET;ORAL 25MG A085231 Aug 26, 1976

QUINIDINE GLUCONATE QUINACT BAYER HLTHCARE TABLET;ORAL 266MG A085978 May 15, 1978

QUINIDINE GLUCONATE QUINACT BAYER HLTHCARE TABLET;ORAL 400MG A086099 May 15, 1978

QUINIDINE GLUCONATE QUINATIME WATSON LABS

TABLET, 

EXTENDED 

RELEASE;ORAL 324MG A087448 Nov 20, 1981

QUINIDINE GLUCONATE QUINIDINE GLUCONATE ANI PHARMS

TABLET, 

EXTENDED 

RELEASE;ORAL 324MG A087810 Sep 29, 1982

QUINIDINE GLUCONATE QUINIDINE GLUCONATE CYCLE PHARMS LTD

TABLET, 

EXTENDED 

RELEASE;ORAL 324MG A088431 Jan 06, 1984

QUINIDINE GLUCONATE QUINIDINE GLUCONATE WATSON LABS

TABLET, 

EXTENDED 

RELEASE;ORAL 324MG A087785 Jan 24, 1983

QUINIDINE SULFATE CIN-QUIN SOLVAY CAPSULE;ORAL 200MG A085296 Apr 01, 1977

QUINIDINE SULFATE CIN-QUIN SOLVAY CAPSULE;ORAL 300MG A085297 Apr 01, 1977

QUINIDINE SULFATE CIN-QUIN SOLVAY TABLET;ORAL 200MG A084932 Nov 08, 1976

QUINIDINE SULFATE CIN-QUIN SOLVAY TABLET;ORAL 300MG A085298 Nov 08, 1976

QUINIDINE SULFATE CIN-QUIN SOLVAY TABLET;ORAL 100MG A085299 Nov 08, 1976

QUINIDINE SULFATE QUINIDINE SULFATE BARR TABLET;ORAL 200MG A084177 Sep 30, 1976

QUINIDINE SULFATE QUINIDINE SULFATE CONTRACT PHARMACAL TABLET;ORAL 200MG A083808 Feb 14, 1977

QUINIDINE SULFATE QUINIDINE SULFATE CYCLE PHARMS LTD TABLET;ORAL 200MG A083640 Jul 15, 1975

QUINIDINE SULFATE QUINIDINE SULFATE CYCLE PHARMS LTD TABLET;ORAL 300MG A085632 Aug 02, 1977

QUINIDINE SULFATE QUINIDINE SULFATE DAVA PHARMS INC TABLET;ORAL 200MG A087011 Aug 29, 1979

QUINIDINE SULFATE QUINIDINE SULFATE ELKINS SINN TABLET;ORAL 200MG A083622 Nov 24, 1976

QUINIDINE SULFATE QUINIDINE SULFATE EVERYLIFE TABLET;ORAL 200MG A083439 Mar 19, 1979

QUINIDINE SULFATE QUINIDINE SULFATE HALSEY TABLET;ORAL 200MG A083583 Sep 03, 1976

QUINIDINE SULFATE QUINIDINE SULFATE HIKMA TABLET;ORAL 200MG A083862 Sep 02, 1976

QUINIDINE SULFATE QUINIDINE SULFATE IMPAX LABS TABLET;ORAL 200MG A083347 Dec 08, 1976

QUINIDINE SULFATE QUINIDINE SULFATE IVAX SUB TEVA PHARMS TABLET;ORAL 200MG A084549 Aug 31, 1976

QUINIDINE SULFATE QUINIDINE SULFATE KING PHARMS TABLET;ORAL 200MG A085175 Sep 30, 1976

QUINIDINE SULFATE QUINIDINE SULFATE KV PHARM TABLET;ORAL 200MG A085276 Jan 18, 1977

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QUINIDINE SULFATE QUINIDINE SULFATE LANNETT TABLET;ORAL 200MG A083743 Jan 14, 1977

QUINIDINE SULFATE QUINIDINE SULFATE LEDERLE TABLET;ORAL 200MG A086176 Feb 03, 1978

QUINIDINE SULFATE QUINIDINE SULFATE LILLY CAPSULE;ORAL 200MG A085103 Jul 08, 1976

QUINIDINE SULFATE QUINIDINE SULFATE LILLY TABLET;ORAL 200MG A085038 Jul 08, 1976

QUINIDINE SULFATE QUINIDINE SULFATE PERRIGO TABLET;ORAL 200MG A085322 Oct 18, 1977

QUINIDINE SULFATE QUINIDINE SULFATE PHARMAVITE TABLET;ORAL 200MG A084627 Jul 20, 1977

QUINIDINE SULFATE QUINIDINE SULFATE PUREPAC PHARM TABLET;ORAL 200MG A084003 Oct 06, 1976

QUINIDINE SULFATE QUINIDINE SULFATE SANDOZ TABLET;ORAL 200MG A084631 Nov 24, 1976

QUINIDINE SULFATE QUINIDINE SULFATE SANDOZ TABLET;ORAL 200MG A084914 Aug 18, 1977

QUINIDINE SULFATE QUINIDINE SULFATE SCHERER LABS TABLET;ORAL 200MG A085068 Feb 01, 1977

QUINIDINE SULFATE QUINIDINE SULFATE USL PHARMA TABLET;ORAL 200MG A087837 Apr 14, 1982

QUINIDINE SULFATE QUINIDINE SULFATE VALEANT PHARM INTL TABLET;ORAL 200MG A083393 Apr 29, 1977

QUINIDINE SULFATE QUINIDINE SULFATE VANGARD TABLET;ORAL 200MG A087909 Jul 13, 1982

QUINIDINE SULFATE QUINIDINE SULFATE VINTAGE PHARMS TABLET;ORAL 200MG A083963 Mar 14, 1977

QUINIDINE SULFATE QUINIDINE SULFATE WARNER CHILCOTT TABLET;ORAL 200MG A083879 Jan 16, 1976

QUINIDINE SULFATE QUINIDINE SULFATE WATSON LABS TABLET;ORAL 200MG A083288 Nov 24, 1976

QUINIDINE SULFATE QUINIDINE SULFATE WATSON LABS TABLET;ORAL 200MG A085140 Jul 14, 1977

QUINIDINE SULFATE QUINIDINE SULFATE WATSON LABS TABLET;ORAL 300MG A085583 Jun 09, 1981

QUINIDINE SULFATE QUINIDINE SULFATE WATSON LABS TABLET;ORAL 100MG A085584 Jun 09, 1981

QUINIDINE SULFATE QUINIDINE SULFATE WHITEWORTH TOWN PLSN TABLET;ORAL 200MG A085444 Jul 13, 1978

QUINIDINE SULFATE QUINORA KEY PHARMS TABLET;ORAL 200MG A083576 Mar 19, 1975

QUINIDINE SULFATE QUINORA SCHERING TABLET;ORAL 300MG A085222 Jan 25, 1978

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA HALSEY TABLET;ORAL 100MG A080498 Jul 26, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA HALSEY TABLET;ORAL 50MG A080498 Jul 26, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA PUREPAC PHARM TABLET;ORAL 100MG A080842 Oct 05, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA PUREPAC PHARM TABLET;ORAL 50MG A080842 Oct 05, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA PVT FORM TABLET;ORAL 100MG A080583 May 15, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA PVT FORM TABLET;ORAL 50MG A080583 May 15, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA SOLVAY TABLET;ORAL 100MG A080500 Jul 11, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA SOLVAY TABLET;ORAL 50MG A080500 Jul 11, 1972

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA TABLICAPS TABLET;ORAL 100MG A083444 Sep 26, 1975

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA TABLICAPS TABLET;ORAL 50MG A083867 Jan 22, 1975

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA WATSON LABS TABLET;ORAL 100MG A080914 Feb 15, 1973

RAUWOLFIA SERPENTINA ROOT RAUWOLFIA SERPENTINA WATSON LABS TABLET;ORAL 50MG A080907 Nov 08, 1972

RESCINNAMINE CINNASIL PANRAY CAPSULE;ORAL 0.5MG A084736 Mar 07, 1977

RESERPINE RESERPINE BARR TABLET;ORAL 0.25MG A080721 Jan 13, 1977

RESERPINE RESERPINE BELL PHARMA TABLET;ORAL 0.1MG A083058 Oct 10, 1974

RESERPINE RESERPINE BELL PHARMA TABLET;ORAL 0.25MG A083058 Oct 10, 1974

RESERPINE RESERPINE ELKINS SINN TABLET;ORAL 0.1MG A083145 May 07, 1973

RESERPINE RESERPINE ELKINS SINN TABLET;ORAL 0.25MG A083145 May 07, 1973

RESERPINE RESERPINE HALSEY TABLET;ORAL 0.1MG A080457 Jun 21, 1972

RESERPINE RESERPINE HALSEY TABLET;ORAL 0.25MG A080457 Jun 21, 1972

RESERPINE RESERPINE HALSEY TABLET;ORAL 1MG A080457 Jun 21, 1971

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NUMBER

APPROVAL DATE

RESERPINE RESERPINE HIKMA INTL PHARMS TABLET;ORAL 0.1MG A080975 Dec 26, 1972

RESERPINE RESERPINE HIKMA INTL PHARMS TABLET;ORAL 0.25MG A080975 Dec 26, 1972

RESERPINE RESERPINE HIKMA INTL PHARMS TABLET;ORAL 1MG A080975 Dec 26, 1972

RESERPINE RESERPINE MARSHALL PHARMA TABLET;ORAL 0.1MG A080492 Aug 07, 1973

RESERPINE RESERPINE MARSHALL PHARMA TABLET;ORAL 0.25MG A080492 Aug 07, 1973

RESERPINE RESERPINE MK LABS TABLET;ORAL 0.1MG A080525 Mar 30, 1972

RESERPINE RESERPINE MK LABS TABLET;ORAL 0.25MG A080525 Mar 30, 1972

RESERPINE RESERPINE MYLAN TABLET;ORAL 1MG A084974 Apr 26, 1978

RESERPINE RESERPINE PHARMAVITE TABLET;ORAL 0.25MG A084663 Dec 09, 1975

RESERPINE RESERPINE PUREPAC PHARM TABLET;ORAL 0.1MG A080753 Jan 11, 1973

RESERPINE RESERPINE PUREPAC PHARM TABLET;ORAL 0.25MG A080753 Jan 11, 1973

RESERPINE RESERPINE PVT FORM TABLET;ORAL 0.1MG A086117 Mar 06, 1979

RESERPINE RESERPINE PVT FORM TABLET;ORAL 0.25MG A085775 Jun 10, 1977

RESERPINE RESERPINE PVT FORM TABLET;ORAL 0.25MG A080582 Aug 24, 1976

RESERPINE RESERPINE PVT FORM TABLET;ORAL 1MG A080582 Aug 24, 1976

RESERPINE RESERPINE REXALL TABLET;ORAL 0.25MG A080637 Jun 26, 1972

RESERPINE RESERPINE SOLVAY TABLET;ORAL 0.25MG A080446 Apr 04, 1972

RESERPINE RESERPINE TABLICAPS TABLET;ORAL 0.25MG A085207 Dec 17, 1976

RESERPINE RESERPINE WATSON LABS TABLET;ORAL 0.1MG A080679 Jan 19, 1972

RESERPINE RESERPINE WATSON LABS TABLET;ORAL 0.25MG A080393 Dec 22, 1971

RESERPINE RESERPINE WATSON LABS TABLET;ORAL 0.25MG A085401 Mar 11, 1977

RESERPINE RESERPINE WATSON LABS TABLET;ORAL 1MG A080749 Apr 25, 1973

RESERPINE RESERPINE WHITEWORTH TOWN PLSN TABLET;ORAL 0.1MG A080723 Jul 31, 1973

RESERPINE RESERPINE WHITEWORTH TOWN PLSN TABLET;ORAL 0.25MG A080723 Jul 31, 1973

RESERPINE RESERPINE WHITEWORTH TOWN PLSN TABLET;ORAL 1MG A080723 Jul 31, 1973

RESERPINE; 

TRICHLORMETHIAZIDE

TRICHLORMETHIAZIDE W/ 

RESERPINE WATSON LABS TABLET;ORAL 0.1MG;4MG A085248 Nov 15, 1976

SECOBARBITAL SODIUM SECOBARBITAL SODIUM ANABOLIC CAPSULE;ORAL 100MG A084422 Dec 19, 1974

SECOBARBITAL SODIUM SECOBARBITAL SODIUM BARR CAPSULE;ORAL 100MG A084225 Apr 07, 1975

SECOBARBITAL SODIUM SECOBARBITAL SODIUM ELKINS SINN

INJECTABLE;INJE

CTION 100MG/VIAL A083281 Aug 05, 1974

SECOBARBITAL SODIUM SECOBARBITAL SODIUM EVERYLIFE CAPSULE;ORAL 100MG A085895 Oct 30, 1978

SECOBARBITAL SODIUM SECOBARBITAL SODIUM HALSEY CAPSULE;ORAL 100MG A084676 Feb 23, 1976

SECOBARBITAL SODIUM SECOBARBITAL SODIUM IVAX PHARMS CAPSULE;ORAL 100MG A085869 Oct 25, 1977

SECOBARBITAL SODIUM SECOBARBITAL SODIUM KV PHARM CAPSULE;ORAL 100MG A085285 Dec 02, 1976

SECOBARBITAL SODIUM SECOBARBITAL SODIUM LANNETT CAPSULE;ORAL 100MG A085903 Apr 24, 1978

SECOBARBITAL SODIUM SECOBARBITAL SODIUM LANNETT CAPSULE;ORAL 50MG A085909 Jun 08, 1978

SECOBARBITAL SODIUM SECOBARBITAL SODIUM PARKE DAVIS CAPSULE;ORAL 100MG A084762 Sep 12, 1975

SECOBARBITAL SODIUM SECOBARBITAL SODIUM PERRIGO CAPSULE;ORAL 100MG A084561 May 04, 1977

SECOBARBITAL SODIUM SECOBARBITAL SODIUM PUREPAC PHARM CAPSULE;ORAL 100MG A085867 Mar 07, 1978

SECOBARBITAL SODIUM SECOBARBITAL SODIUM VALEANT PHARM INTL CAPSULE;ORAL 100MG A085477 Dec 10, 1981

SECOBARBITAL SODIUM SECOBARBITAL SODIUM VITARINE CAPSULE;ORAL 100MG A085898 Feb 04, 1981

SECOBARBITAL SODIUM SECOBARBITAL SODIUM VITARINE CAPSULE;ORAL 100MG A086273 Jun 09, 1978

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NUMBER

APPROVAL DATE

SECOBARBITAL SODIUM SECOBARBITAL SODIUM WATSON LABS CAPSULE;ORAL 100MG A085792 Jan 13, 1978

SECOBARBITAL SODIUM SECOBARBITAL SODIUM WEST WARD CAPSULE;ORAL 100MG A084926 Jul 07, 1976

SECOBARBITAL SODIUM SECOBARBITAL SODIUM WHITEWORTH TOWN PLSN CAPSULE;ORAL 100MG A085798 Apr 24, 1978

SECOBARBITAL SODIUM SECOBARBITAL SODIUM WYETH AYERST CAPSULE;ORAL 100MG A086390 Dec 31, 1980

SECOBARBITAL SODIUM SECOBARBITAL SODIUM WYETH AYERST

INJECTABLE;INJE

CTION 50MG/ML A083262 Dec 03, 1973

SECOBARBITAL SODIUM SECONAL SODIUM LILLY

SUPPOSITORY;REC

TAL 120MG A086530 Jul 09, 1981

SECOBARBITAL SODIUM SECONAL SODIUM LILLY

SUPPOSITORY;REC

TAL 200MG A086530 Jul 09, 1981

SECOBARBITAL SODIUM SECONAL SODIUM LILLY

SUPPOSITORY;REC

TAL 30MG A086530 Jul 09, 1981

SECOBARBITAL SODIUM SECONAL SODIUM LILLY

SUPPOSITORY;REC

TAL 60MG A086530 Jul 09, 1981

SECOBARBITAL SODIUM SECONAL SODIUM VALEANT PHARMS NORTH CAPSULE;ORAL 100MG A086101 Oct 03, 1983

SECOBARBITAL SODIUM SECONAL SODIUM VALEANT PHARMS NORTH CAPSULE;ORAL 50MG A086101 Oct 03, 1983

SELENIUM SULFIDE EXSEL ALLERGAN HERBERT

LOTION/SHAMPOO;

TOPICAL 2.5% A083892 Jan 21, 1974

SELENIUM SULFIDE SELENIUM SULFIDE ACTAVIS MID ATLANTIC

LOTION/SHAMPOO;

TOPICAL 2.5% A084394 May 14, 1975

SELENIUM SULFIDE SELENIUM SULFIDE COSETTE

LOTION/SHAMPOO;

TOPICAL 2.5% A086209 Nov 04, 1981

SELENIUM SULFIDE SELENIUM SULFIDE IVAX PHARMS

LOTION/SHAMPOO;

TOPICAL 2.5% A085777 Jul 03, 1980

SODIUM POLYSTYRENE 

SULFONATE SODIUM POLYSTYRENE SULFONATE MORTON GROVE

SUSPENSION;ORAL

, RECTAL 15GM/60ML A088717 Sep 11, 1984

SODIUM POLYSTYRENE 

SULFONATE SODIUM POLYSTYRENE SULFONATE ROXANE

SUSPENSION;ORAL

, RECTAL 15GM/60ML A088453 Nov 17, 1983

SODIUM POLYSTYRENE 

SULFONATE SODIUM POLYSTYRENE SULFONATE WOCKHARDT

POWDER;ORAL, 

RECTAL 453.6GM/BOT A088786 Sep 11, 1984

SODIUM SUCCINATE SODIUM SUCCINATE ELKINS SINN

INJECTABLE;INJE

CTION 30% A080516 Nov 16, 1971

SPIRONOLACTONE SPIRONOLACTONE ASCOT TABLET;ORAL 25MG A087687 Oct 20, 1982

SPIRONOLACTONE SPIRONOLACTONE CHARTWELL RX TABLET;ORAL 25MG A086809 Jul 10, 1980

SPIRONOLACTONE SPIRONOLACTONE IVAX PHARMS TABLET;ORAL 25MG A087108 May 07, 1980

SPIRONOLACTONE SPIRONOLACTONE LEDERLE TABLET;ORAL 25MG A087634 Sep 10, 1981

SPIRONOLACTONE SPIRONOLACTONE MUTUAL PHARM TABLET;ORAL 25MG A087265 Jan 28, 1981

SPIRONOLACTONE SPIRONOLACTONE MYLAN TABLET;ORAL 25MG A087086 Feb 03, 1981

SPIRONOLACTONE SPIRONOLACTONE PUREPAC PHARM TABLET;ORAL 25MG A087998 Oct 14, 1983

SPIRONOLACTONE SPIRONOLACTONE PUREPAC PHARM TABLET;ORAL 25MG A088053 Aug 25, 1983

SPIRONOLACTONE SPIRONOLACTONE UPSHER SMITH TABLET;ORAL 25MG A087554 Nov 16, 1981

SPIRONOLACTONE SPIRONOLACTONE VANGARD TABLET;ORAL 25MG A087648 Feb 01, 1982

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NUMBER

APPROVAL DATE

SPIRONOLACTONE SPIRONOLACTONE WARNER CHILCOTT TABLET;ORAL 25MG A087952 Nov 18, 1982

SPIRONOLACTONE SPIRONOLACTONE WATSON LABS TABLET;ORAL 25MG A087078 Feb 23, 1981

SPIRONOLACTONE SPIRONOLACTONE WATSON LABS TABLET;ORAL 25MG A086898 Mar 02, 1982

SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE INTL MEDICATION

INJECTABLE;INJE

CTION 100MG/VIAL A085400 Feb 04, 1982

SUCCINYLCHOLINE CHLORIDE SUCCINYLCHOLINE CHLORIDE ORGANON USA INC

INJECTABLE;INJE

CTION 20MG/ML A080997 Sep 20, 1972

SULFACETAMIDE SODIUM BLEPH-10 ALLERGAN

OINTMENT;OPHTHA

LMIC 10% A084015 Jan 07, 1975

SULFACETAMIDE SODIUM BLEPH-30 ALLERGAN

SOLUTION/DROPS;

OPHTHALMIC 30% A080028 May 25, 1971

SULFACETAMIDE SODIUM CETAMIDE ALCON

OINTMENT;OPHTHA

LMIC 10% A080021 Sep 27, 1972

SULFACETAMIDE SODIUM ISOPTO CETAMIDE ALCON

SOLUTION/DROPS;

OPHTHALMIC 15% A080020 May 05, 1971

SULFACETAMIDE SODIUM OCUSULF-10 MIZA PHARMS USA

SOLUTION/DROPS;

OPHTHALMIC 10% A080660 Aug 24, 1972

SULFACETAMIDE SODIUM OCUSULF-30 MIZA PHARMS USA

SOLUTION/DROPS;

OPHTHALMIC 30% A080660 Aug 24, 1972

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE AKORN

SOLUTION/DROPS;

OPHTHALMIC 10% A083021 Jan 16, 1975

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE AKORN

SOLUTION/DROPS;

OPHTHALMIC 15% A083021 Jan 16, 1975

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE AKORN

SOLUTION/DROPS;

OPHTHALMIC 30% A083021 Jan 16, 1975

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 10% A084145 Nov 01, 1974

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 10% A084143 Nov 22, 1974

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 30% A084146 Nov 01, 1974

SULFACETAMIDE SODIUM SODIUM SULFACETAMIDE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC 30% A084147 Dec 10, 1974

SULFACETAMIDE SODIUM SULF-10 NOVARTIS

SOLUTION/DROPS;

OPHTHALMIC 10% A080025 Jun 03, 1971

SULFACETAMIDE SODIUM SULFACEL-15 OPTOPICS

SOLUTION/DROPS;

OPHTHALMIC 15% A080024 Sep 29, 1970

SULFACETAMIDE SODIUM SULFAIR 10 PHARMAFAIR

OINTMENT;OPHTHA

LMIC 10% A088000 Dec 22, 1982

SULFACETAMIDE SODIUM SULFAIR 10 PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 10% A087949 Dec 13, 1982

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NUMBER

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SULFACETAMIDE SODIUM SULFAIR FORTE PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 30% A088385 Oct 13, 1983

SULFACETAMIDE SODIUM SULFAIR-15 PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 15% A088186 May 25, 1983

SULFACETAMIDE SODIUM SULTEN-10 BAUSCH AND LOMB

SOLUTION/DROPS;

OPHTHALMIC 10% A087818 Feb 03, 1983

SULFADIAZINE SULFADIAZINE EVERYLIFE TABLET;ORAL 500MG A080088 Jun 27, 1972

SULFADIAZINE SULFADIAZINE IMPAX LABS TABLET;ORAL 500MG A080081 Aug 01, 1973

SULFADIAZINE SULFADIAZINE LANNETT TABLET;ORAL 500MG A080084 Jul 05, 1978

SULFAMETHIZOLE MICROSUL FOREST PHARMS TABLET;ORAL 1GM A086012 Aug 11, 1978

SULFAMETHIZOLE PROKLAR FOREST PHARMS TABLET;ORAL 500MG A080273 Jun 27, 1972

SULFAMETHOXAZOLE SULFAMETHOXAZOLE ASCOT TABLET;ORAL 500MG A087662 Oct 20, 1982

SULFAMETHOXAZOLE SULFAMETHOXAZOLE BARR TABLET;ORAL 500MG A087189 Jul 25, 1983

SULFAMETHOXAZOLE SULFAMETHOXAZOLE HEATHER TABLET;ORAL 500MG A086163 Aug 18, 1980

SULFAMETHOXAZOLE SULFAMETHOXAZOLE RISING TABLET;ORAL 500MG A085844 Mar 23, 1978

SULFAMETHOXAZOLE SULFAMETHOXAZOLE WATSON LABS TABLET;ORAL 500MG A085053 Aug 11, 1977

SULFAMETHOXAZOLE SULFAMETHOXAZOLE WATSON LABS TABLET;ORAL 1GM A086000 Mar 24, 1978

SULFAMETHOXAZOLE UROBAK SHIONOGI TABLET;ORAL 500MG A087307 Mar 20, 1981

SULFASALAZINE S.A.S.-500 SOLVAY TABLET;ORAL 500MG A083450 Apr 09, 1974

SULFASALAZINE SULFASALAZINE CHARTWELL TABLET;ORAL 500MG A080197 Nov 12, 1973

SULFASALAZINE SULFASALAZINE SANDOZ TABLET;ORAL 500MG A086184 May 15, 1981

SULFASALAZINE SULFASALAZINE WATSON LABS

TABLET, DELAYED 

RELEASE;ORAL 500MG A088052 May 24, 1983

SULFASALAZINE SULFASALAZINE WATSON LABS TABLET;ORAL 500MG A087197 Apr 02, 1981

SULFASALAZINE SULFASALAZINE WATSON LABS TABLET;ORAL 500MG A084964 May 12, 1976

SULFINPYRAZONE SULFINPYRAZONE BARR CAPSULE;ORAL 200MG A087666 Sep 17, 1982

SULFINPYRAZONE SULFINPYRAZONE BARR TABLET;ORAL 100MG A087665 Sep 17, 1982

SULFINPYRAZONE SULFINPYRAZONE IVAX PHARMS CAPSULE;ORAL 200MG A087770 Nov 19, 1982

SULFINPYRAZONE SULFINPYRAZONE IVAX PHARMS TABLET;ORAL 100MG A087769 Jun 01, 1982

SULFINPYRAZONE SULFINPYRAZONE VANGARD CAPSULE;ORAL 200MG A088666 Feb 17, 1984

SULFINPYRAZONE SULFINPYRAZONE WATSON LABS TABLET;ORAL 100MG A087667 May 26, 1982

SULFISOXAZOLE SOSOL MK LABS TABLET;ORAL 500MG A080036 Feb 09, 1973

SULFISOXAZOLE SOXAZOLE ALRA TABLET;ORAL 500MG A080366 Jun 07, 1971

SULFISOXAZOLE SULFALAR PARKE DAVIS TABLET;ORAL 500MG A084955 Jan 05, 1977

SULFISOXAZOLE SULFISOXAZOLE ANI PHARMS TABLET;ORAL 500MG A080142 Mar 06, 1974

SULFISOXAZOLE SULFISOXAZOLE BARR TABLET;ORAL 500MG A084031 Feb 13, 1975

SULFISOXAZOLE SULFISOXAZOLE HEATHER TABLET;ORAL 500MG A080189 May 02, 1974

SULFISOXAZOLE SULFISOXAZOLE IMPAX LABS TABLET;ORAL 500MG A080109 Apr 30, 1974

SULFISOXAZOLE SULFISOXAZOLE LANNETT TABLET;ORAL 500MG A080085 Mar 06, 1978

SULFISOXAZOLE SULFISOXAZOLE LEDERLE TABLET;ORAL 500MG A087649 Sep 28, 1981

SULFISOXAZOLE SULFISOXAZOLE PHARMERAL TABLET;ORAL 500MG A084385 Nov 05, 1980

SULFISOXAZOLE SULFISOXAZOLE PUREPAC PHARM TABLET;ORAL 500MG A080087 Jun 29, 1972

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NUMBER

APPROVAL DATE

SULFISOXAZOLE SULFISOXAZOLE RISING TABLET;ORAL 500MG A085628 Jun 13, 1977

SULFISOXAZOLE SULFISOXAZOLE ROXANE TABLET;ORAL 500MG A080082 May 31, 1972

SULFISOXAZOLE SULFISOXAZOLE VALEANT PHARM INTL TABLET;ORAL 500MG A080268 Apr 18, 1977

SULFISOXAZOLE SULFISOXAZOLE VITARINE TABLET;ORAL 500MG A087332 Jul 22, 1981

SULFISOXAZOLE SULFISOXAZOLE WATSON LABS TABLET;ORAL 500MG A085534 Aug 08, 1978

SULFISOXAZOLE SULFISOXAZOLE WEST WARD TABLET;ORAL 500MG A080379 Feb 13, 1973

SULFISOXAZOLE SULSOXIN SOLVAY TABLET;ORAL 500MG A080040 Jun 15, 1972

SULFISOXAZOLE DIOLAMINE SULFISOXAZOLE DIOLAMINE SOLA BARNES HIND

SOLUTION/DROPS;

OPHTHALMIC EQ 4% BASE A084148 Jan 22, 1975

TESTOSTERONE TESTOSTERONE DR REDDYS

INJECTABLE;INJE

CTION 100MG/ML A086417 Jul 07, 1983

TESTOSTERONE TESTOSTERONE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A086420 May 10, 1983

TESTOSTERONE TESTOSTERONE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A086419 Aug 23, 1983

TESTOSTERONE CYPIONATE DEPO-TESTOSTERONE PFIZER

INJECTABLE;INJE

CTION 50MG/ML A085635 Jul 25, 1979

TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A086029 Jun 23, 1978

TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A084401 Aug 01, 1977

TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE WATSON LABS

INJECTABLE;INJE

CTION 200MG/ML A084401 Aug 01, 1977

TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE WATSON LABS

INJECTABLE;INJE

CTION 200MG/ML A083667 Jul 05, 1977

TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A085599 Dec 10, 1980

TESTOSTERONE ENANTHATE TESTOSTERONE ENANTHATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A083667 Jul 05, 1977

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE BEL MAR

INJECTABLE;INJE

CTION 100MG/ML A080743 Dec 03, 1973

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE BEL MAR

INJECTABLE;INJE

CTION 25MG/ML A080741 Dec 03, 1973

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE BEL MAR

INJECTABLE;INJE

CTION 50MG/ML A080742 Dec 03, 1973

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE ELKINS SINN

INJECTABLE;INJE

CTION 25MG/ML A080276 Mar 16, 1972

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE LILLY

INJECTABLE;INJE

CTION 50MG/ML A080254 Feb 28, 1972

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A083595 Jan 30, 1978

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NUMBER

APPROVAL DATE

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A080188 May 02, 1974

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A080188 May 02, 1974

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 25MG/ML A085490 Jul 01, 1977

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A080188 May 02, 1974

TESTOSTERONE PROPIONATE TESTOSTERONE PROPIONATE WATSON LABS

INJECTABLE;INJE

CTION 50MG/ML A085490 Jul 01, 1977

THEOPHYLLINE AQUAPHYLLIN FERNDALE LABS SYRUP;ORAL 80MG/15ML A087917 Jan 18, 1983

THEOPHYLLINE BRONKODYL SANOFI AVENTIS US CAPSULE;ORAL 100MG A085264 Jul 13, 1979

THEOPHYLLINE BRONKODYL SANOFI AVENTIS US CAPSULE;ORAL 200MG A085264 Jul 13, 1979

THEOPHYLLINE ELIXICON FOREST LABS SUSPENSION;ORAL 100MG/5ML A085502 Aug 11, 1980

THEOPHYLLINE ELIXOMIN CENCI ELIXIR;ORAL 80MG/15ML A088303 Jan 25, 1984

THEOPHYLLINE ELIXOPHYLLIN FOREST LABS CAPSULE;ORAL 100MG A085545 Jul 31, 1984

THEOPHYLLINE ELIXOPHYLLIN FOREST LABS CAPSULE;ORAL 200MG A083921 Jul 31, 1984

THEOPHYLLINE LABID WARNER CHILCOTT

TABLET, 

EXTENDED 

RELEASE;ORAL 250MG A087225 Apr 13, 1981

THEOPHYLLINE LANOPHYLLIN LANNETT ELIXIR;ORAL 80MG/15ML A084578 Jul 26, 1976

THEOPHYLLINE QUIBRON-T/SR MONARCH PHARMS

TABLET, 

EXTENDED 

RELEASE;ORAL 300MG A087563 Jun 21, 1983

THEOPHYLLINE SLO-PHYLLIN SANOFI AVENTIS US

CAPSULE, 

EXTENDED 

RELEASE;ORAL 125MG A085203 May 24, 1982

THEOPHYLLINE SLO-PHYLLIN SANOFI AVENTIS US

CAPSULE, 

EXTENDED 

RELEASE;ORAL 250MG A085205 May 24, 1982

THEOPHYLLINE SLO-PHYLLIN SANOFI AVENTIS US

CAPSULE, 

EXTENDED 

RELEASE;ORAL 60MG A085206 May 24, 1982

THEOPHYLLINE SLO-PHYLLIN SANOFI AVENTIS US SYRUP;ORAL 80MG/15ML A085187 May 15, 1979

THEOPHYLLINE SLO-PHYLLIN SANOFI AVENTIS US TABLET;ORAL 100MG A085202 Nov 14, 1979

THEOPHYLLINE SLO-PHYLLIN SANOFI AVENTIS US TABLET;ORAL 200MG A085204 Nov 14, 1979

THEOPHYLLINE SOMOPHYLLIN-CRT GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 100MG A087194 Sep 17, 1981

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NUMBER

APPROVAL DATE

THEOPHYLLINE SOMOPHYLLIN-CRT GRAHAM DM

CAPSULE, 

EXTENDED 

RELEASE;ORAL 250MG A087193 Sep 17, 1981

THEOPHYLLINE SUSTAIRE ROERIG

TABLET, 

EXTENDED 

RELEASE;ORAL 100MG A085665 Aug 03, 1979

THEOPHYLLINE SUSTAIRE ROERIG

TABLET, 

EXTENDED 

RELEASE;ORAL 300MG A085665 Aug 03, 1979

THEOPHYLLINE THEOCHRON NOSTRUM PHARMS LLC

TABLET, 

EXTENDED 

RELEASE;ORAL 300MG A087400 Jan 11, 1983

THEOPHYLLINE THEOCLEAR L.A.-130 SCHWARZ PHARMA

CAPSULE, 

EXTENDED 

RELEASE;ORAL 130MG A086569 May 27, 1982

THEOPHYLLINE THEOCLEAR L.A.-260 SCHWARZ PHARMA

CAPSULE, 

EXTENDED 

RELEASE;ORAL 260MG A086569 May 27, 1982

THEOPHYLLINE THEOCLEAR-100 CENT PHARMS TABLET;ORAL 100MG A085353 Aug 11, 1980

THEOPHYLLINE THEOCLEAR-200 CENT PHARMS TABLET;ORAL 200MG A085353 Aug 11, 1980

THEOPHYLLINE THEOCLEAR-80 CENT PHARMS SYRUP;ORAL 80MG/15ML A087095 Mar 01, 1982

THEOPHYLLINE THEO-DUR SCHERING

TABLET, 

EXTENDED 

RELEASE;ORAL 100MG A085328 Apr 12, 1979

THEOPHYLLINE THEO-DUR SCHERING

TABLET, 

EXTENDED 

RELEASE;ORAL 200MG A086998 Jan 31, 1980

THEOPHYLLINE THEO-DUR SCHERING

TABLET, 

EXTENDED 

RELEASE;ORAL 300MG A085328 Apr 10, 1979

THEOPHYLLINE THEOLAIR 3M SOLUTION;ORAL 80MG/15ML A086107 Mar 26, 1979

THEOPHYLLINE THEOLAIR MEDICIS TABLET;ORAL 125MG A086399 May 30, 1980

THEOPHYLLINE THEOLAIR MEDICIS TABLET;ORAL 250MG A086399 May 30, 1980

THEOPHYLLINE THEOLIXIR PANRAY ELIXIR;ORAL 80MG/15ML A084559 Apr 23, 1976

THEOPHYLLINE THEOPHYL-225 ORTHO MCNEIL PHARM ELIXIR;ORAL 112.5MG/15ML A086485 Oct 22, 1981

THEOPHYLLINE THEOPHYL-225 ORTHO MCNEIL PHARM TABLET;ORAL 225MG A084726 Nov 14, 1980

THEOPHYLLINE THEOPHYLLINE ALPHARMA US PHARMS SYRUP;ORAL 80MG/15ML A086001 Nov 20, 1981

THEOPHYLLINE THEOPHYLLINE ALPHARMA US PHARMS SYRUP;ORAL 150MG/15ML A086545 Oct 16, 1981

THEOPHYLLINE THEOPHYLLINE CENCI ELIXIR;ORAL 80MG/15ML A087679 Apr 15, 1982

THEOPHYLLINE THEOPHYLLINE CHARTWELL RX ELIXIR;ORAL 80MG/15ML A085952 Apr 04, 1979

THEOPHYLLINE THEOPHYLLINE HALSEY ELIXIR;ORAL 80MG/15ML A085169 Feb 08, 1979

THEOPHYLLINE THEOPHYLLINE KV PHARM CAPSULE;ORAL 100MG A085263 Jul 13, 1979

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

THEOPHYLLINE THEOPHYLLINE KV PHARM CAPSULE;ORAL 200MG A085263 Jul 13, 1979

THEOPHYLLINE THEOPHYLLINE PHARM ASSOC ELIXIR;ORAL 80MG/15ML A086720 Jun 25, 1980

THEOPHYLLINE THEOPHYLLINE PRECISION DOSE ELIXIR;ORAL 80MG/15ML A085863 Mar 16, 1979

THEOPHYLLINE THEOPHYLLINE ROXANE ELIXIR;ORAL 80MG/15ML A084739 Sep 28, 1981

THEOPHYLLINE THEOPHYLLINE ROXANE SOLUTION;ORAL 80MG/15ML A087449 Sep 15, 1983

THEOPHYLLINE THEOPHYLLINE SANDOZ

CAPSULE, 

EXTENDED 

RELEASE;ORAL 260MG A087462 May 11, 1982

THEOPHYLLINE THEOPHYLLINE WOCKHARDT ELIXIR;ORAL 80MG/15ML A086748 Jan 30, 1980

THEOPHYLLINE T-PHYL PHARM RES ASSOC

TABLET, 

EXTENDED 

RELEASE;ORAL 200MG A088253 Aug 17, 1983

THEOPHYLLINE SODIUM 

GLYCINATE ASBRON NOVARTIS TABLET;ORAL EQ 150MG BASE A085148 Jun 01, 1979

THIAMINE HYDROCHLORIDE BETALIN S LILLY

INJECTABLE;INJE

CTION 100MG/ML A080853 Apr 03, 1973

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE ABRAXIS PHARM

INJECTABLE;INJE

CTION 100MG/ML A080509 Mar 29, 1972

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE AKORN

INJECTABLE;INJE

CTION 100MG/ML A087968 Oct 01, 1982

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 100MG/ML A080718 Feb 04, 1974

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE BEL MAR

INJECTABLE;INJE

CTION 200MG/ML A080712 Feb 26, 1974

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE DELL LABS

INJECTABLE;INJE

CTION 100MG/ML A083775 Aug 06, 1974

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 100MG/ML A080571 Feb 26, 1974

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE DR REDDYS

INJECTABLE;INJE

CTION 200MG/ML A080571 Feb 26, 1974

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE LUITPOLD

INJECTABLE;INJE

CTION 100MG/ML A080667 Jul 28, 1972

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE PARKE DAVIS

INJECTABLE;INJE

CTION 100MG/ML A080770 Dec 06, 1972

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A083534 Jul 06, 1977

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 200MG/ML A083534 Jul 06, 1977

THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE WYETH AYERST

INJECTABLE;INJE

CTION 100MG/ML A080553 Mar 27, 1974

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ACTAVIS MID ATLANTIC

CONCENTRATE;ORA

L 100MG/ML A088229 Aug 23, 1983

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NUMBER

APPROVAL DATE

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ALPHARMA US PHARMS

CONCENTRATE;ORA

L 30MG/ML A087766 Apr 26, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 100MG A088273 Oct 03, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 10MG A088270 Apr 14, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 15MG A088271 Apr 14, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 25MG A088272 Apr 14, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ANI PHARMS TABLET;ORAL 50MG A088194 Apr 14, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE FOSUN PHARMA TABLET;ORAL 10MG A088131 Aug 30, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE FOSUN PHARMA TABLET;ORAL 15MG A088132 Aug 30, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE FOSUN PHARMA TABLET;ORAL 25MG A088133 Aug 30, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE FOSUN PHARMA TABLET;ORAL 50MG A088134 Aug 30, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA TABLET;ORAL 100MG A088736 Jul 24, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA TABLET;ORAL 10MG A088476 Nov 08, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA TABLET;ORAL 25MG A088478 Nov 08, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE HERITAGE PHARMA TABLET;ORAL 50MG A088479 Nov 08, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 100MG A088379 Nov 16, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 10MG A088375 Nov 18, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 25MG A087264 Nov 18, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MUTUAL PHARM TABLET;ORAL 50MG A088370 Nov 18, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET;ORAL 100MG A088335 Nov 18, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET;ORAL 10MG A088332 Jun 27, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET;ORAL 25MG A088333 Jun 27, 1983

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NUMBER

APPROVAL DATE

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE MYLAN TABLET;ORAL 50MG A088334 Jun 27, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE PAR PHARM TABLET;ORAL 100MG A088480 Dec 29, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE PAR PHARM TABLET;ORAL 10MG A088351 Dec 05, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE PAR PHARM TABLET;ORAL 15MG A088352 Dec 05, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE PAR PHARM TABLET;ORAL 25MG A088336 Dec 05, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE PAR PHARM TABLET;ORAL 50MG A088322 Dec 05, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ROXANE TABLET;ORAL 10MG A088663 Mar 15, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ROXANE TABLET;ORAL 25MG A088664 Mar 15, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE ROXANE TABLET;ORAL 50MG A088665 Mar 15, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE SANDOZ

CONCENTRATE;ORA

L 100MG/ML A088308 Nov 23, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE SANDOZ

CONCENTRATE;ORA

L 30MG/ML A088307 Nov 23, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE SUN PHARM INDUSTRIES TABLET;ORAL 15MG A088461 Nov 18, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 100MG A088564 May 11, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 100MG A088284 Aug 25, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A088561 May 11, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 10MG A088412 Sep 12, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 150MG A088410 Mar 05, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 15MG A088562 May 11, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 15MG A088345 Jul 28, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 200MG A088381 Mar 14, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A088755 Jul 24, 1984

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NUMBER

APPROVAL DATE

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 25MG A088296 Jul 28, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A088563 May 11, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A088323 Jul 28, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TEVA TABLET;ORAL 15MG A088477 Nov 08, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WATSON LABS TEVA TABLET;ORAL 25MG A088567 May 11, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 10MG A088658 Mar 26, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 15MG A088659 Mar 26, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 25MG A088660 Mar 26, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WEST WARD TABLET;ORAL 50MG A088661 Mar 26, 1984

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WOCKHARDT

CONCENTRATE;ORA

L 100MG/ML A088227 Jul 05, 1983

THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE WOCKHARDT

CONCENTRATE;ORA

L 30MG/ML A088258 Jul 25, 1983

TOLBUTAMIDE TOLBUTAMIDE ALRA TABLET;ORAL 500MG A086141 Aug 03, 1979

TOLBUTAMIDE TOLBUTAMIDE ANI PHARMS TABLET;ORAL 500MG A087093 Mar 25, 1980

TOLBUTAMIDE TOLBUTAMIDE ASCOT TABLET;ORAL 500MG A087541 Mar 01, 1983

TOLBUTAMIDE TOLBUTAMIDE BARR TABLET;ORAL 500MG A087121 Feb 20, 1981

TOLBUTAMIDE TOLBUTAMIDE DAVA PHARMS INC TABLET;ORAL 500MG A086926 Feb 05, 1980

TOLBUTAMIDE TOLBUTAMIDE PARKE DAVIS TABLET;ORAL 500MG A086047 Nov 21, 1979

TOLBUTAMIDE TOLBUTAMIDE VANGARD TABLET;ORAL 500MG A087876 Apr 20, 1982

TOLBUTAMIDE TOLBUTAMIDE WATSON LABS TABLET;ORAL 500MG A086109 Jan 30, 1979

TOLBUTAMIDE TOLBUTAMIDE WATSON LABS TABLET;ORAL 500MG A087318 Mar 31, 1981

TOLBUTAMIDE TOLBUTAMIDE YAOPHARMA CO LTD TABLET;ORAL 500MG A086574 Jun 04, 1980

TRIAMCINOLONE TRIAMCINOLONE BARR TABLET;ORAL 2MG A084318 Oct 22, 1975

TRIAMCINOLONE TRIAMCINOLONE BARR TABLET;ORAL 2MG A084286 Nov 04, 1975

TRIAMCINOLONE TRIAMCINOLONE BARR TABLET;ORAL 4MG A084319 Oct 21, 1975

TRIAMCINOLONE TRIAMCINOLONE BARR TABLET;ORAL 4MG A084267 Oct 22, 1975

TRIAMCINOLONE TRIAMCINOLONE BARR TABLET;ORAL 8MG A084268 Oct 16, 1975

TRIAMCINOLONE TRIAMCINOLONE BARR TABLET;ORAL 8MG A084320 Oct 22, 1975

TRIAMCINOLONE TRIAMCINOLONE IMPAX LABS TABLET;ORAL 4MG A084340 Apr 22, 1975

TRIAMCINOLONE TRIAMCINOLONE IVAX SUB TEVA PHARMS TABLET;ORAL 4MG A083750 Mar 11, 1974

TRIAMCINOLONE TRIAMCINOLONE MYLAN TABLET;ORAL 2MG A084406 Apr 07, 1975

TRIAMCINOLONE TRIAMCINOLONE PUREPAC PHARM TABLET;ORAL 2MG A084020 Jun 09, 1975

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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TRIAMCINOLONE TRIAMCINOLONE PUREPAC PHARM TABLET;ORAL 4MG A084020 Jun 09, 1975

TRIAMCINOLONE TRIAMCINOLONE ROXANE TABLET;ORAL 2MG A084708 Aug 19, 1975

TRIAMCINOLONE TRIAMCINOLONE ROXANE TABLET;ORAL 4MG A084709 Aug 13, 1975

TRIAMCINOLONE TRIAMCINOLONE ROXANE TABLET;ORAL 8MG A084707 Aug 13, 1975

TRIAMCINOLONE TRIAMCINOLONE SANDOZ TABLET;ORAL 4MG A085601 May 31, 1977

TRIAMCINOLONE TRIAMCINOLONE TEVA TABLET;ORAL 4MG A084775 Jan 19, 1976

TRIAMCINOLONE TRIAMCINOLONE WATSON LABS TABLET;ORAL 4MG A084270 Feb 08, 1977

TRIAMCINOLONE TRIAMCINOLONE WATSON LABS TABLET;ORAL 4MG A085834 Jan 10, 1978

TRIAMCINOLONE ACETONIDE ARISTOCORT ASTELLAS CREAM;TOPICAL 0.025% A083017 Sep 05, 1972

TRIAMCINOLONE ACETONIDE ARISTOCORT ASTELLAS CREAM;TOPICAL 0.1% A083016 Sep 06, 1972

TRIAMCINOLONE ACETONIDE ARISTOCORT ASTELLAS CREAM;TOPICAL 0.5% A083015 Aug 16, 1974

TRIAMCINOLONE ACETONIDE ARISTOCORT ASTELLAS

OINTMENT;TOPICA

L 0.1% A080750 Jun 28, 1976

TRIAMCINOLONE ACETONIDE ARISTOCORT ASTELLAS

OINTMENT;TOPICA

L 0.5% A080745 May 28, 1974

TRIAMCINOLONE ACETONIDE ARISTOCORT A ASTELLAS CREAM;TOPICAL 0.025% A083017 Mar 05, 1976

TRIAMCINOLONE ACETONIDE ARISTOCORT A ASTELLAS CREAM;TOPICAL 0.1% A083016 Sep 15, 1975

TRIAMCINOLONE ACETONIDE ARISTOCORT A ASTELLAS CREAM;TOPICAL 0.5% A083015 Aug 24, 1973

TRIAMCINOLONE ACETONIDE ARISTOCORT A ASTELLAS

OINTMENT;TOPICA

L 0.1% A080750 May 13, 1974

TRIAMCINOLONE ACETONIDE ARISTOCORT A ASTELLAS

OINTMENT;TOPICA

L 0.5% A080745 Sep 23, 1975

TRIAMCINOLONE ACETONIDE ARISTOGEL ASTELLAS GEL;TOPICAL 0.1% A083380 Apr 30, 1973

TRIAMCINOLONE ACETONIDE FLUTEX IVAX PHARMS CREAM;TOPICAL 0.025% A085539 Jun 23, 1978

TRIAMCINOLONE ACETONIDE FLUTEX IVAX PHARMS CREAM;TOPICAL 0.1% A085539 Jun 23, 1978

TRIAMCINOLONE ACETONIDE FLUTEX IVAX PHARMS CREAM;TOPICAL 0.5% A085539 Jun 23, 1978

TRIAMCINOLONE ACETONIDE KENALOG DELCOR ASSET CORP CREAM;TOPICAL 0.5% A083943 Jan 29, 1974

TRIAMCINOLONE ACETONIDE KENALOG DELCOR ASSET CORP LOTION;TOPICAL 0.025% A084343 Jul 16, 1974

TRIAMCINOLONE ACETONIDE KENALOG DELCOR ASSET CORP LOTION;TOPICAL 0.1% A084343 Jul 16, 1974

TRIAMCINOLONE ACETONIDE KENALOG DELCOR ASSET CORP

OINTMENT;TOPICA

L 0.5% A083944 Jan 29, 1974

TRIAMCINOLONE ACETONIDE KENALOG-H DELCOR ASSET CORP CREAM;TOPICAL 0.1% A086240 Jun 22, 1978

TRIAMCINOLONE ACETONIDE TRIACET TEVA CREAM;TOPICAL 0.025% A084908 May 24, 1976

TRIAMCINOLONE ACETONIDE TRIACET TEVA CREAM;TOPICAL 0.1% A084908 May 24, 1976

TRIAMCINOLONE ACETONIDE TRIACET TEVA CREAM;TOPICAL 0.5% A084908 May 24, 1976

TRIAMCINOLONE ACETONIDE TRIACORT SOLVAY CREAM;TOPICAL 0.1% A087113 Oct 22, 1981

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE ACTAVIS MID ATLANTIC CREAM;TOPICAL 0.1% A087798 Jun 04, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE ACTAVIS MID ATLANTIC

OINTMENT;TOPICA

L 0.1% A087799 Jun 07, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE ALPHARMA US PHARMS CREAM;TOPICAL 0.025% A087797 Jun 07, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE ALPHARMA US PHARMS LOTION;TOPICAL 0.025% A087191 Sep 08, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE ALPHARMA US PHARMS LOTION;TOPICAL 0.1% A087192 Sep 08, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE AMBIX CREAM;TOPICAL 0.025% A087932 May 09, 1983

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ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE MORTON GROVE CREAM;TOPICAL 0.025% A088094 Sep 01, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE MORTON GROVE CREAM;TOPICAL 0.1% A088095 Sep 01, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE MORTON GROVE CREAM;TOPICAL 0.5% A088096 Sep 01, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE MORTON GROVE

OINTMENT;TOPICA

L 0.025% A088090 Sep 01, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE MORTON GROVE

OINTMENT;TOPICA

L 0.1% A088091 Sep 01, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE MORTON GROVE

OINTMENT;TOPICA

L 0.5% A088092 Sep 01, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMADERM CREAM;TOPICAL 0.025% A087990 Jul 07, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMADERM CREAM;TOPICAL 0.1% A087991 Jul 07, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMADERM CREAM;TOPICAL 0.5% A087992 Jul 07, 1983

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMADERM

OINTMENT;TOPICA

L 0.025% A088692 Aug 02, 1984

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMADERM

OINTMENT;TOPICA

L 0.1% A088690 Aug 02, 1984

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMAFAIR CREAM;TOPICAL 0.025% A087921 Aug 10, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMAFAIR CREAM;TOPICAL 0.1% A087912 Aug 10, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE PHARMAFAIR CREAM;TOPICAL 0.5% A087922 Aug 10, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TARO CREAM;TOPICAL 0.025% A086277 Apr 10, 1979

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TARO CREAM;TOPICAL 0.1% A086276 Apr 10, 1979

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TARO CREAM;TOPICAL 0.5% A086275 Apr 10, 1979

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE TARO

OINTMENT;TOPICA

L 0.1% A087902 Dec 27, 1982

TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE WATSON LABS

INJECTABLE;INJE

CTION 40MG/ML A085825 Nov 05, 1981

TRIAMCINOLONE ACETONIDE TRYMEX SAVAGE LABS CREAM;TOPICAL 0.025% A088196 Mar 25, 1983

TRIAMCINOLONE ACETONIDE TRYMEX SAVAGE LABS CREAM;TOPICAL 0.1% A088197 Mar 25, 1983

TRIAMCINOLONE ACETONIDE TRYMEX SAVAGE LABS CREAM;TOPICAL 0.5% A088198 Mar 25, 1983

TRIAMCINOLONE ACETONIDE TRYMEX SAVAGE LABS

OINTMENT;TOPICA

L 0.025% A088693 Aug 02, 1984

TRIAMCINOLONE ACETONIDE TRYMEX SAVAGE LABS

OINTMENT;TOPICA

L 0.1% A088691 Aug 02, 1984

TRIAMCINOLONE DIACETATE TRIAMCINOLONE DIACETATE AKORN

INJECTABLE;INJE

CTION 25MG/ML A085122 Aug 31, 1979

TRIAMCINOLONE DIACETATE TRIAMCINOLONE DIACETATE AKORN

INJECTABLE;INJE

CTION 40MG/ML A086394 Mar 16, 1981

TRIAMCINOLONE DIACETATE TRIAMCINOLONE DIACETATE WATSON LABS

INJECTABLE;INJE

CTION 40MG/ML A084072 Jan 24, 1977

TRIAMCINOLONE DIACETATE TRIAMCINOLONE DIACETATE WATSON LABS

INJECTABLE;INJE

CTION 40MG/ML A085529 Mar 07, 1978

TRICHLORMETHIAZIDE TRICHLOREX LANNETT TABLET;ORAL 4MG A083436 Aug 11, 1980

Current as of July 2021 Page 125 of 130
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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TRICHLORMETHIAZIDE TRICHLOREX LANNETT TABLET;ORAL 4MG A085630 May 16, 1977

TRICHLORMETHIAZIDE TRICHLORMAS MAST MM TABLET;ORAL 4MG A086259 Jul 19, 1979

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE CHARTWELL RX TABLET;ORAL 4MG A085568 Oct 05, 1977

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE IMPAX LABS TABLET;ORAL 4MG A083967 Jan 17, 1978

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE PAR PHARM TABLET;ORAL 2MG A087007 Feb 06, 1981

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE PAR PHARM TABLET;ORAL 4MG A087005 Feb 06, 1981

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE SANDOZ TABLET;ORAL 4MG A086171 Nov 02, 1981

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE WATSON LABS TABLET;ORAL 2MG A086458 Oct 31, 1978

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE WATSON LABS TABLET;ORAL 2MG A083847 Feb 06, 1978

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE WATSON LABS TABLET;ORAL 4MG A083855 Dec 02, 1977

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE WATSON LABS TABLET;ORAL 4MG A083462 Mar 29, 1976

TRICHLORMETHIAZIDE TRICHLORMETHIAZIDE WATSON LABS TABLET;ORAL 4MG A085962 Jun 06, 1978

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE FOSUN PHARMA

CONCENTRATE;ORA

L

EQ 10MG 

BASE/ML A085787 Apr 15, 1982

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE IVAX PHARMS TABLET;ORAL EQ 10MG BASE A087614 Nov 19, 1982

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE IVAX PHARMS TABLET;ORAL EQ 1MG BASE A087612 Nov 19, 1982

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE IVAX PHARMS TABLET;ORAL EQ 2MG BASE A087613 Nov 19, 1982

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE IVAX PHARMS TABLET;ORAL EQ 5MG BASE A087328 Nov 19, 1982

TRIFLUOPERAZINE 

HYDROCHLORIDE

TRIFLUOPERAZINE 

HYDROCHLORIDE WOCKHARDT

CONCENTRATE;ORA

L

EQ 10MG 

BASE/ML A088143 Jul 26, 1983

TRIHEXYPHENIDYL 

HYDROCHLORIDE TREMIN SCHERING TABLET;ORAL 2MG A080381 Mar 14, 1973

TRIHEXYPHENIDYL 

HYDROCHLORIDE TREMIN SCHERING TABLET;ORAL 5MG A080381 Mar 18, 1977

TRIHEXYPHENIDYL 

HYDROCHLORIDE

TRIHEXYPHENIDYL 

HYDROCHLORIDE NYLOS TABLET;ORAL 5MG A085622 Mar 20, 1978

TRIHEXYPHENIDYL 

HYDROCHLORIDE

TRIHEXYPHENIDYL 

HYDROCHLORIDE VANGARD TABLET;ORAL 2MG A088035 Jul 30, 1982

TRIHEXYPHENIDYL 

HYDROCHLORIDE

TRIHEXYPHENIDYL 

HYDROCHLORIDE WATSON LABS TABLET;ORAL 2MG A085117 Aug 20, 1976

TRIHEXYPHENIDYL 

HYDROCHLORIDE

TRIHEXYPHENIDYL 

HYDROCHLORIDE WATSON LABS TABLET;ORAL 5MG A085105 Jul 29, 1976

TRIMEPRAZINE TARTRATE TRIMEPRAZINE TARTRATE ALPHARMA US PHARMS SYRUP;ORAL

EQ 2.5MG 

BASE/5ML A085015 Feb 18, 1982

TRIMETHOBENZAMIDE 

HYDROCHLORIDE

TRIMETHOBENZAMIDE 

HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A086577 Oct 19, 1982

TRIMETHOBENZAMIDE 

HYDROCHLORIDE

TRIMETHOBENZAMIDE 

HYDROCHLORIDE WATSON LABS

INJECTABLE;INJE

CTION 100MG/ML A087939 Dec 28, 1982

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TRIPELENNAMINE 

HYDROCHLORIDE PBZ NOVARTIS TABLET;ORAL 25MG A083149 Sep 06, 1973

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE ANABOLIC TABLET;ORAL 50MG A083037 Nov 03, 1972

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE BARR TABLET;ORAL 50MG A080744 Sep 27, 1972

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE HEATHER TABLET;ORAL 50MG A083989 Jun 04, 1974

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE IMPAX LABS TABLET;ORAL 50MG A080785 Aug 07, 1973

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE LANNETT TABLET;ORAL 50MG A083557 May 10, 1974

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE NYLOS TABLET;ORAL 50MG A085412 Apr 29, 1977

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE PARKE DAVIS TABLET;ORAL 50MG A083626 Jan 21, 1974

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE PARKE DAVIS TABLET;ORAL 25MG A083625 Jan 21, 1974

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A080713 Jan 18, 1973

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A085188 Aug 11, 1976

TRIPELENNAMINE 

HYDROCHLORIDE TRIPELENNAMINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 50MG A080790 Sep 21, 1972

TRIPLE SULFA 

(SULFABENZAMIDE;SULFACETAMI

DE;SULFATHIAZOLE) TRIPLE SULFA ALPHARMA US PHARMS CREAM;VAGINAL

3.7%;2.86%;3.4

2% A087864 Sep 01, 1982

TRIPLE SULFA 

(SULFABENZAMIDE;SULFACETAMI

DE;SULFATHIAZOLE) TRIPLE SULFA FOUGERA CREAM;VAGINAL

3.7%;2.86%;3.4

2% A086424 May 31, 1979

TRIPLE SULFA 

(SULFABENZAMIDE;SULFACETAMI

DE;SULFATHIAZOLE) TRIPLE SULFA PERRIGO NEW YORK CREAM;VAGINAL

3.7%;2.86%;3.4

2% A087285 Nov 15, 1982

TRIPLE SULFA 

(SULFABENZAMIDE;SULFACETAMI

DE;SULFATHIAZOLE) TRYSUL SAVAGE LABS CREAM;VAGINAL

3.7%;2.86%;3.4

2% A087887 Jul 23, 1982

TRIPROLIDINE HYDROCHLORIDE MYIDYL USL PHARMA SYRUP;ORAL 1.25MG/5ML A087963 Jan 18, 1983

TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE ALPHARMA US PHARMS SYRUP;ORAL 1.25MG/5ML A085940 Jul 13, 1979

TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE PHARM ASSOC SYRUP;ORAL 1.25MG/5ML A087514 Feb 10, 1982

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ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE VITARINE TABLET;ORAL 2.5MG A085610 Mar 21, 1978

TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE HYDROCHLORIDE WATSON LABS TABLET;ORAL 2.5MG A085094 Feb 07, 1977

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) LANTRISUL LANNETT SUSPENSION;ORAL

167MG/5ML;167M

G/5ML;167MG/5M

L A080123 Aug 24, 1978

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) SULFALOID FOREST PHARMS SUSPENSION;ORAL

167MG/5ML;167M

G/5ML;167MG/5M

L A080100 Sep 30, 1970

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) SULFALOID FOREST PHARMS TABLET;ORAL

167MG;167MG;16

7MG A080099 Oct 09, 1970

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) SULFA-TRIPLE #2 IMPAX LABS TABLET;ORAL

167MG;167MG;16

7MG A080079 Jan 23, 1974

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) SULFOSE WYETH AYERST SUSPENSION;ORAL

167MG/5ML;167M

G/5ML;167MG/5M

L A080013 Jul 07, 1972

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) SULFOSE WYETH AYERST TABLET;ORAL

167MG;167MG;16

7MG A080013 Jul 07, 1972

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) TRIPLE SULFA ALPHARMA US PHARMS SUSPENSION;ORAL

167MG/5ML;167M

G/5ML;167MG/5M

L A080280 Jun 02, 1976

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) TRIPLE SULFA PUREPAC PHARM TABLET;ORAL

167MG;167MG;16

7MG A080086 Jan 09, 1973

TRISULFAPYRIMIDINES 

(SULFADIAZINE;SULFAMERAZINE

;SULFAMETHAZINE) TRIPLE SULFOID PAL PAK TABLET;ORAL

167MG;167MG;16

7MG A080094 Jun 12, 1975

TROPICAMIDE MYDRIAFAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 0.5% A088274 Sep 16, 1983

TROPICAMIDE MYDRIAFAIR PHARMAFAIR

SOLUTION/DROPS;

OPHTHALMIC 1% A088230 Sep 16, 1983

TROPICAMIDE TROPICAMIDE MIZA PHARMS USA

SOLUTION/DROPS;

OPHTHALMIC 0.5% A087636 Jul 30, 1982

TROPICAMIDE TROPICAMIDE MIZA PHARMS USA

SOLUTION/DROPS;

OPHTHALMIC 1% A087637 Aug 09, 1982

VITAMIN A AQUASOL A ASTRAZENECA CAPSULE;ORAL

25,000USP 

UNITS A083080 Jun 12, 1973

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STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

VITAMIN A AQUASOL A ASTRAZENECA CAPSULE;ORAL

50,000USP 

UNITS A083080 Jun 12, 1973

VITAMIN A VITAMIN A BANNER PHARMACAPS CAPSULE;ORAL

50,000USP 

UNITS A083973 Jul 03, 1974

VITAMIN A VITAMIN A CHASE CHEM CAPSULE;ORAL 50,000 IU A083351 Mar 22, 1976

VITAMIN A VITAMIN A EVERYLIFE CAPSULE;ORAL 50,000 IU A083134 Aug 14, 1972

VITAMIN A VITAMIN A IMPAX LABS CAPSULE;ORAL

50,000USP 

UNITS A080952 Jul 13, 1973

VITAMIN A VITAMIN A WEST WARD CAPSULE;ORAL

50,000USP 

UNITS A080985 Sep 19, 1973

VITAMIN A PALMITATE AFAXIN STERLING WINTHROP CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083187 Nov 17, 1972

VITAMIN A PALMITATE ALPHALIN LILLY CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080883 Jul 18, 1973

VITAMIN A PALMITATE DEL-VI-A DEL RAY LABS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080830 Jul 07, 1975

VITAMIN A PALMITATE VI-DOM-A BAYER PHARMS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080972 Mar 14, 1973

VITAMIN A PALMITATE VITAMIN A BANNER PHARMACAPS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080702 Jun 19, 1980

VITAMIN A PALMITATE VITAMIN A BRISTOL MYERS SQUIBB CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080860 Dec 27, 1972

VITAMIN A PALMITATE VITAMIN A CHASE CHEM CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080746 Aug 07, 1972

VITAMIN A PALMITATE VITAMIN A CHASE CHEM CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083207 Sep 25, 1973

VITAMIN A PALMITATE VITAMIN A ELKINS SINN CAPSULE;ORAL

EQ 50,000 

UNITS BASE A085479 May 18, 1977

VITAMIN A PALMITATE VITAMIN A EVERYLIFE CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083114 Aug 14, 1972

VITAMIN A PALMITATE VITAMIN A EVERYLIFE CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080943 Aug 14, 1972

VITAMIN A PALMITATE VITAMIN A IMPAX LABS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080953 Aug 01, 1973

VITAMIN A PALMITATE VITAMIN A IMPAX LABS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080955 Aug 02, 1973

VITAMIN A PALMITATE VITAMIN A IVAX SUB TEVA PHARMS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083190 Dec 19, 1972

VITAMIN A PALMITATE VITAMIN A IVAX SUB TEVA PHARMS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083035 Dec 20, 1972

VITAMIN A PALMITATE VITAMIN A MK LABS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083457 May 02, 1973

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PRE-HATCH-WAXMAN ABBREVIATED NEW DRUG APPLICATIONS IN THE DISCONTINUED PRODUCT LIST

ESTABLISHED NAME PROPRIETARY NAME APPLICATION HOLDER DOSAGE FORM; 

ROUTE

STRENGTH APPLICATION 

NUMBER

APPROVAL DATE

VITAMIN A PALMITATE VITAMIN A MK LABS CAPSULE;ORAL

EQ 25,000 

UNITS BASE A083457 May 20, 1977

VITAMIN A PALMITATE VITAMIN A WEST WARD CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080967 May 04, 1973

VITAMIN A PALMITATE VITAMIN A WHARTON LABS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083665 Nov 13, 1973

VITAMIN A PALMITATE VITAMIN A PALMITATE ARCUM CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083311 May 09, 1975

VITAMIN A PALMITATE VITAMIN A PALMITATE ARCUM CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083321 May 09, 1975

VITAMIN A PALMITATE VITAMIN A PALMITATE BANNER PHARMACAPS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083981 Dec 24, 1974

VITAMIN A PALMITATE VITAMIN A PALMITATE BANNER PHARMACAPS CAPSULE;ORAL

EQ 50,000 

UNITS BASE A083948 Jun 10, 1974

VITAMIN A PALMITATE VITAMIN A PALMITATE BEL MAR

INJECTABLE;INJE

CTION

EQ 50,000 

UNITS BASE/ML A080819 Mar 06, 1974

VITAMIN A PALMITATE VITAMIN A SOLUBILIZED TEVA CAPSULE;ORAL

EQ 50,000 

UNITS BASE A080921 Jul 28, 1972

WARFARIN SODIUM WARFARIN SODIUM WATSON LABS TABLET;ORAL 10MG A086122 Aug 17, 1982

WARFARIN SODIUM WARFARIN SODIUM WATSON LABS TABLET;ORAL 7.5MG A086118 Aug 17, 1982

WARFARIN SODIUM WARFARIN SODIUM WATSON LABS TABLET;ORAL 2.5MG A086120 Aug 17, 1982

WARFARIN SODIUM WARFARIN SODIUM WATSON LABS TABLET;ORAL 2MG A086123 Aug 17, 1982

WARFARIN SODIUM WARFARIN SODIUM WATSON LABS TABLET;ORAL 5MG A086119 Aug 17, 1982

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