Document ID: FDA-2015-N-3432-0001
Agency: fda
Document Type: Notice
Title: Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications
Posted Date: 2015-10-13T04:00Z

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61426-61430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25922]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3432]

Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug 
Applications and 128 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 67 new drug applications (NDAs) and 128 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the Agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: Effective Date: November 12, 2015.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 in this document have informed FDA that these drug products are 
no longer marketed and have requested that FDA withdraw approval of the 
applications under the process in Sec.  314.150(c) (21 CFR 314.150(c)). 
The applicants have also, by their requests, waived their opportunity 
for a hearing. Withdrawal of approval of an application or abbreviated 
application under Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
      Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 001104................  Doca                   Organon USA Inc.,
                             (desoxycorticosteron   Subsidiary of Merck
                             e acetate)             Sharp & Dohme Corp.,
                             Injection, 5           2000 Galloping Hill
                             milligrams (mg)/       Rd., Kenilworth, NJ
                             milliliter (mL).       07033.
NDA 004589................  Alcohol in Dextrose    B. Braun Medical
                             Injection USP, 10 mL/  Inc., 901 Marcon
                             100 mL and 5 grams     Blvd., Allentown, PA
                             (g)/100 mL.            18109.
NDA 006170................  Hyprotigen (modified   Do.
                             protein hydrolysate)
                             Injection, 5%.
NDA 012154................  Ureaphil (urea) for    Hospira, Inc., 275
                             Injection, 40 g/vial.  North Field Dr.,
                                                    Lake Forest, IL
                                                    60045.
NDA 012449................  Oratrol                Alcon Laboratories
                             (dichlorphenamide)     Inc., 6201 South
                             Tablets, 50 mg.        Freeway, P.O. Box
                                                    1959, Fort Worth, TX
                                                    76134.
NDA 012699................  Lomotil (atropine      G.D. Searle, LLC, 235
                             sulfate and            East 42nd St., New
                             diphenoxylate          York, NY 10017.
                             hydrochloride (HCl))
                             Solution 0.025 mg/5
                             mL and 2.5 mg/5 mL.
NDA 012892................  Uracil Mustard         Shire Development
                             Capsule.               Inc., 725
                                                    Chesterbrook Blvd.,
                                                    Wayne, PA 19087-
                                                    5637.
NDA 014738................  Mannitol Injection     B. Braun Medical Inc.
                             USP, 20%.
NDA 016080................  Mannitol Injection     Do.
                             USP.
NDA 016096................  Mintezol               Merck Sharp & Dohme
                             (thiabendazole)        Corp., 1 Merck
                             Tablets.               Drive, P.O. Box 100,
                                                    Whitehouse Station,
                                                    NJ 08889.
NDA 016097................  Mintezol               Do.
                             (thiabendazole) Oral
                             Suspension.
NDA 016695................  Dextrose Injection,    Baxter Healthcare
                             5% (in Ringer's).      Corp. 32650 N.
                                                    Wilson Rd., Round
                                                    Lake, IL 60073.
NDA 017390................  Plasma-Lyte M and      Do.
                             Dextrose 5%
                             Injection.
NDA 017438................  Plasma-Lyte R          Do.
                             Injection.
NDA 017451................  Plasma Lyte 148 and    Do.
                             Dextrose 5%
                             Injection.
NDA 017493................  Travasol (amino        Do.
                             acids) Injection,
                             10%.
NDA 017510................  Dextrose 5% Injection  B. Braun Medical Inc.
                             (in lactated
                             Ringer's).
NDA 017636................  Sorbitol-Mannitol      Hospira, Inc.
                             Irrigation, 2.7 g/
                             100 mL-540 mg/100 mL.
NDA 017698................  Serile Urea Injection  Do.
NDA 017911................  Clinoril (sulindac)    Merck Sharp & Dohme
                             Tablets, 150 mg and    Corp.
                             200 mg.
NDA 017957................  Novamine (amino        Hospira, Inc.
                             acids) Injection.
NDA 017995................  Dextrose Injection     B. Braun Medical Inc.
                             USP, 60%.
NDA 018191................  Drixoral Non-Drowsy    MSD Consumer Care,
                             (pseudoephedrine       Inc., 556 Morris
                             sulfate) Extended-     Ave., Summit, NJ
                             Release Tablets, 120   07901.
                             mg.
NDA 018242................  Sulfamethoxazole and   Teva Pharmaceuticals
                             Trimethorim Tablets    USA, 425 Privet Rd.,
                             USP.                   Horsham, PA 19044.
NDA 018258................  Dextrose Injection 5%  B. Braun Medical Inc.
                             (in acetated
                             Ringer's).
NDA 018268................  Dextrose, Sodium       Do.
                             Chloride, and
                             Potassium Chloride
                             Injection USP, 5%.
NDA 018307................  Thyro-Block            Meda Pharmaceuticals
                             (potassium iodide      Inc., 265 Davidson
                             tablets USP).          Ave., Suite 400,
                                                    Somerset, NJ 08873.
NDA 018308................  Thyro-Block            Do.
                             (potassium iodide
                             solution), 21 mg.
NDA 018312................  Calderol               Organon USA Inc.,
                             (calcifediol)          Subsidiary of Merck
                             Capsules.              & Co., Inc.
NDA 018376................  Dextrose and Sodium    B. Braun Medical Inc.
                             Chloride Injection,
                             2.5%/0.9%.
NDA 018531................  Nitroglycerin          Hospira, Inc.
                             Injection USP, 5 mg/
                             mL.
NDA 018533................  Nizoral                Janssen
                             (ketoconazole)         Pharmaceuticals,
                             Tablets, 200 mg.       Inc., c/o Janssen
                                                    Research &
                                                    Development, LLC,
                                                    920 Route 202 South,
                                                    P.O. Box 300,
                                                    Raritan, NJ 08869-
                                                    0602.
NDA 018684................  Branchamin (amino      Baxter Healthcare
                             acids) Injection, 4%.  Corp.
NDA 018722................  Sodium Chloride 0.9%,  B. Braun Medical Inc.
                             and Potassium
                             Chloride Injection.
NDA 018725................  Acetated Ringer's      Do.
                             Injection.

[[Page 61427]]

 
NDA 018744................  Dextrose and           Do.
                             Potassium Chloride
                             Injection.
NDA 018818................  Metronidazole Tablets  Mutual Pharmaceutical
                             USP, 250 mg and 500    Co., Inc., 1100
                             mg.                    Orthodox St.,
                                                    Philadelphia, PA
                                                    19124.
NDA 018840................  Dextrose 5%, and       Baxter Healthcare
                             Electrolyte No. 75     Corp.
                             Injection.
NDA 019037................  Imodium (loperamide    Janssen
                             HCl) Oral Solution,    Pharmaceuticals,
                             1 mg/5 mL.             Inc., c/o Janssen
                                                    Research &
                                                    Development, LLC,
                                                    1125 Trenton-
                                                    Harbourton Rd., P.O.
                                                    Box 200, Titusville,
                                                    NJ 08560.
NDA 019047................  Plasma-Lyte 56         Baxter Healthcare
                             (electrolyte           Corp.
                             solution) Injection.
NDA 019439................  K-Dur (potassium       Merck Sharp & Dohme
                             chloride) Extended-    Corp.
                             Release Tablets, 10
                             milliequivalents
                             (mEq) and 20 mEq.
NDA 019645................  Toradol (ketorolac     Roche Palo Alto LLC,
                             tromethamine)          c/o Genetech, Inc.,
                             Tablets, 10 mg.        1 DNA Way, South San
                                                    Francisco, CA 94080-
                                                    4990.
NDA 019681................  Aminosyn II in         Hospira, Inc.
                             Dextrose Injection.
NDA 019682................  Aminosyn II with       Do.
                             Electrolytes and
                             Adjusted Phosphate
                             in Dextrose
                             Injection.
NDA 019683................  Aminosyn II with       Do.
                             Electrolytes in
                             Dextrose with
                             Calcium Injection.
NDA 019718................  Isolyte E (multi-      B. Braun Medical Inc.
                             electrolyte)
                             Injection.
NDA 019778................  Prinzide (lisinopril   Merck Sharp & Dohme
                             and                    Corp.
                             hydrochlorothiazide)
                             Tablets, 10 mg/12.5
                             mg, 20 mg/12.5 mg,
                             and 20 mg/25 mg.
NDA 019843................  Isolyte S (multi-      B. Braun Medical Inc.
                             electrolyte) in
                             Dextrose 5%
                             Injection.
NDA 019864................  Isolyte R (multi-      Do.
                             electrolyte) in
                             Dextrose 5%
                             Injection.
NDA 019867................  Isolyte E (multi-      Do.
                             electrolyte) in
                             Dextrose 5%
                             Injection.
NDA 020004................  Sodium Lactate         Do.
                             Injection USP, 1/6
                             molar.
NDA 020173................  Travasol (amino        Baxter Healthcare
                             acids) Injection       Corp.
                             With Electrolytes in
                             Dextrose.
NDA 020177................  Travasol (amino        Do.
                             acids) Injection
                             With Electrolytes.
NDA 020536................  Nicotrol (nicotine     McNeil Consumer
                             transdermal system),   Healthcare, 7050
                             15 mg.                 Camp Hill Rd., Fort
                                                    Washington, PA
                                                    19034.
NDA 020004................  Sodium Lactate         B. Braun Medical Inc.
                             Injection USP, 1/6
                             molar.
NDA 020173................  Travasol (amino        Baxter Healthcare
                             acids) Injection       Corp.
                             With Electrolytes in
                             Dextrose.
NDA 020177................  Travasol (amino        Do.
                             acids) Injection
                             With Electrolytes.
NDA 020811................  Acular PF (ketorolac   Allergan, Inc., 2525
                             tromethamine)          Dupont Dr., P.O. Box
                             Ophthalmic Solution,   19534, Irvine, CA
                             0.5%.                  92623-9534.
NDA 021260................  Avinza (morphine       King Pharmaceuticals
                             sulfate) Extended-     LLC, 235 East 42nd
                             Release Capsules.      St., New York, NY
                                                    10017.
NDA 021415................  Metvixia (methyl       Galderma
                             aminolevulinate HCl)   Laboratories, L.P.,
                             Cream, 16.8%.          14501 North Freeway,
                                                    Fort Worth, TX
                                                    76177.
NDA 021460................  Metaglip (glipizide    Bristol-Myers Squibb,
                             and metformin HCl)     P.O. Box 4000
                             Tablets, 2.5 mg/250    (Mailstop D12-02),
                             mg, 2.5 mg/500 mg,     Princeton, NJ 08543-
                             and 5 mg/500 mg.       4000.
NDA 021788................  Synthetic Conjugated   Teva Women's Health,
                             Estrogens, A Vaginal   Inc., 41 Moores Rd.,
                             Cream, 0.625 mg/gram   P.O. Box 4011,
                             (g).                   Frazer, PA 19355.
NDA 021961................  Simvastatin Orally     Synthon
                             Disintegrating         Pharmaceuticals,
                             Tablets, 10 mg, 20     Inc., 9000
                             mg, 40 mg, and 80 mg.  Development Dr.,
                                                    P.O. Box 110487,
                                                    Research Triangle
                                                    Park, NC 27709.
ANDA 040093...............  Digoxin Injection USP  Hospira, Inc.
                             Carpuject, 250
                             micrograms (mcg)/mL.
ANDA 040233...............  Methotrexate Tablets   Barr Laboratories,
                             USP, 2.5 mg.           Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 040285...............  Hydrocodone            Ivax Pharmaceuticals,
                             Bitartrate and         Inc., Subsidiary of
                             Homatropine            Teva Pharmaceuticals
                             Methylbromide Syrup,   USA, 400 Chestnut
                             5 mg/5 mL and 1.5 mg/  Ridge Rd., Woodcliff
                             5 mL.                  Lake, NJ 07677.
ANDA 040287...............  Prednisolone Syrup,    Do.
                             15 mg/5 mL.
ANDA 040435...............  Extended Phenytoin     ANI Pharmaceuticals,
                             Sodium Capsules USP,   Inc., 210 Main St.
                             100 mg.                West, Baudette, MN
                                                    56623.
ANDA 040443...............  Acetaminophen and      Watson Laboratories,
                             Codeine Phosphate      Inc.--Florida, 2945
                             Tablets USP, 300 mg/   West Corporate Lakes
                             15 mg, 300 mg/30 mg,   Blvd., Suite B,
                             and 300 mg/60 mg.      Weston, FL 33331.
NDA 050336................  Tao (troleandomycin)   Pfizer, Inc., 235
                             Capsule.               East 42nd St., New
                                                    York, NY 10017.
NDA 050520................  Spectrobid             Do.
                             (bacampicillin HCl)
                             Tablets.
NDA 050556................  Spectrobid             Do.
                             (bacampicillin HCl)
                             Oral Suspension.
NDA 050809................  Azithromycin for       Teva Parenteral
                             Injection, 500 mg/     Medicines, Inc.,
                             vial and 2.5 g/vial.   Subsidiary of Teva
                                                    Pharmaceuticals USA,
                                                    19 Hughes, Irvine,
                                                    CA 92618-1902.
ANDA 061370...............  Ampicillin Trihydrate  Teva Pharmaceuticals
                             for Oral Suspension,   USA, 425 Privet Rd.,
                             125 mg/5 mL, 250 mg/   Horsham, PA 19044.
                             5 mL.
ANDA 061461...............  Erythromycin Stearate  ANI Pharmaceuticals,
                             Tablets USP, 250 mg    Inc.
                             and 500 mg.
ANDA 062338...............  Eryc (erythromycin     Warner Chilcott (US)
                             delayed-release        Inc., 100 Enterprise
                             capsules USP), 250     Dr., Rockaway, NJ
                             mg.                    07866.
ANDA 062391...............  Doxycycline Hyclate    Mutual Pharmaceutical
                             Tablets USP, 100 mg.   Co., Inc.
ANDA 062418...............  Doxycycline Hyclate    Do.
                             Capsules USP, 50 mg
                             and 100 mg.
ANDA 062645...............  Griseofulvin Tablets   Barr Laboratories,
                             USP, 165 mg.           Inc.
ANDA 062646...............  Ultramicrosize         Do.
                             Griseofulvin Tablets
                             USP, 330 mg.

[[Page 61428]]

 
ANDA 062777...............  Cephalexin for Oral    Barr Laboratories,
                             Suspension USP, 250    Inc., Subsidiary of
                             mg/5 mL.               Teva Pharmaceuticals
                                                    USA, 425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 062778...............  Cephalexin for Oral    Do.
                             Suspension USP, 125
                             mg/5 mL.
ANDA 062826...............  Cephalexin Tablets     Do.
                             USP, 250 mg.
ANDA 062827...............  Cephalexin Tablets     Do.
                             USP, 500 mg.
ANDA 062895...............  Cyclacillin Tablets,   Teva Pharmaceuticals,
                             250 mg and 500 mg.     USA.
ANDA 062930...............  Clindamycin Phosphate  Vintage
                             Topical Solution, 1%.  Pharmaceuticals, 150
                                                    Vintage Dr.,
                                                    Huntsville, AL
                                                    35811.
ANDA 064061...............  Cefaclor Capsules      Ivax Pharmaceuticals,
                             USP, 250 mg and 500    Inc.
                             mg.
ANDA 064070...............  Cefaclor Oral          Do.
                             Suspension USP, 375
                             mg/5 mL.
ANDA 064085...............  Cefaclor Oral          Do.
                             Suspension USP, 250
                             mg/5 mL.
ANDA 064086...............  Cefaclor Oral          Do.
                             Suspension UPS, 187
                             mg/5 mL.
ANDA 064087...............  Cefaclor Oral          Do.
                             Suspension USP, 125
                             mg/5 mL.
ANDA 065297...............  Azithromycin for Oral  Sandoz Inc., 4700
                             Suspension, 100 mg/5   Sandoz Dr., Wilson,
                             mL and 200 mg/5 mL.    NC 27893.
ANDA 070067...............  Indomethacin Capsules  Mutual Pharmaceutical
                             USP, 25 mg.            Co., Inc.
ANDA 070068...............  Indomethacin Capsules  Do.
                             USP, 50 mg.
ANDA 070081...............  Ibuprofen Tablets,     McNeil Consumer
                             400 mg.                Healthcare, 7050
                                                    Camp Hill Rd., Fort
                                                    Washington, PA
                                                    19034.
ANDA 070215...............  Sulfamethoxazole and   Pliva Inc.,
                             Trimethoprim Tablets   Subsidiary of Teva
                             USP, 400 mg/80 mg.     Pharmaceuticals USA,
                                                    425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 070466...............  Allopurinol Tablets    Mutual Pharmaceutical
                             USP, 100 mg.           Co., Inc.
ANDA 070467...............  Allopurinol Tablets    Do.
                             USP, 300 mg.
ANDA 070472...............  Lorazepam Tablets      Do.
                             USP, 0.5 mg.
ANDA 070473...............  Lorazepam Tablets      Do.
                             USP, 1 mg.
ANDA 070474...............  Lorazepam Tablets      Do.
                             USP, 2 mg.
ANDA 070482...............  Verapamil HCl          Do.
                             Tablets, 80 mg.
ANDA 070483...............  Verapamil HCl          Do.
                             Tablets, 120 mg.
ANDA 070578...............  Furosemide Injection   Hospira, Inc.
                             USP, 10 mg/mL.
ANDA 070795...............  Amiloride HCl and      Teva Pharmaceuticals
                             Hydrochlorothiazide    USA.
                             Tablets USP, 5 mg/50
                             mg.
ANDA 070819...............  Metoclopramide Oral    Do.
                             Solution USP, 5 mg/5
                             mL.
ANDA 071259...............  Trimethoprim Tablets,  Do.
                             200 mg.
ANDA 071315...............  Metoclopramide Oral    Do.
                             Solution USP, 5 mg/5
                             mL.
ANDA 071769...............  Ibuprofen Tablets      Ivax Pharmaceuticals,
                             USP, 800 mg.           Inc.
ANDA 072126...............  Methyldopa Tablets,    Barr Laboratories,
                             125 mg.                Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 072127...............  Methyldopa Tablets,    Do.
                             250 mg.
ANDA 072128...............  Methyldopa Tablets,    Do.
                             500 mg.
ANDA 072557...............  Fenoprofen Calcium     Ivax Pharmaceuticals,
                             Tablets USP, 600 mg.   Inc.
ANDA 072779...............  Albuterol Tablets      Teva Pharmaceuticals
                             USP, 2 mg.             USA.
ANDA 072780...............  Albuterol Tablets      Do.
                             USP, 4 mg.
ANDA 073115...............  Amantadine HCl Oral    Do.
                             Solution USP, 50 mg/
                             5 mL.
ANDA 073478...............  Loperamide HCl Oral    Do.
                             Solution, 1 mg/5 mL.
ANDA 073497...............  Lactulose Solution     Do.
                             USP, 10 g/15 mL
                             (Evalose).
ANDA 073504...............  Lactulose Solution     Do.
                             USP, 10 g/15 mL
                             (Heptalac).
ANDA 074101...............  Atenolol Tablets, 25   Pliva, Inc.,
                             mg, 50 mg, and 100     Subsidiary of Teva
                             mg.                    Pharmaceuticals USA.
ANDA 074103...............  Piroxicam Capsules     Teva Pharmaceuticals
                             USP, 10 mg and 20 mg.  USA.
ANDA 074148...............  Piroxicam Capsules     Ivax Pharmaceuticals,
                             USP, 10 mg and 20 mg.  Inc.
ANDA 074344...............  Cimetidine Injection   Hospira, Inc.
                             USP, 300 mg/2 mL.
ANDA 074345...............  Cimetidine Injection   Do.
                             USP, 300 mg/2 mL.
ANDA 074347...............  Cholestyramine for     Teva Pharmaceuticals
                             Oral Suspension USP,   USA.
                             4 g.
ANDA 074348...............  Cholestyramine for     Do.
                             Oral Suspension USP,
                             4 g.
ANDA 074368...............  Nadolol Tablets USP,   Do.
                             80 mg, 120 mg, and
                             160 mg.
ANDA 074390...............  Diclofenac Sodium      Do.
                             Delayed-Release
                             Tablets USP, 75 mg.
ANDA 074401...............  Cimetidine Tablets     Ivax Pharmaceuticals,
                             USP, 200 mg, 300 mg,   Inc.
                             and 400 mg.
ANDA 074402...............  Cimetidine Tablets     Do.
                             USP, 800 mg.
ANDA 074411...............  Flurbiprofen Tablets   Do.
                             USP, 50 mg and 100
                             mg.
ANDA 074500...............  Minoxidil Topical      Copley
                             Solution, 2%.          Pharmaceutical,
                                                    Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 074530...............  Terazosin HCl          Ivax Pharmaceuticals,
                             Tablets, 1 mg, 2 mg,   Inc.
                             5 mg, and 10 mg.
ANDA 074590...............  Captopril Tablets      Do.
                             USP, 12.5 mg, 25 mg,
                             50 mg, and 100 mg.
ANDA 074619...............  Glipizide Tablets      Barr Laboratories,
                             USP, 5 mg and 10 mg.   Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 074859...............  Cimetidine HCl Oral    ANI Pharmaceuticals,
                             Solution, 300 mg/5     Inc.
                             mL.
ANDA 074873...............  Tretinoin Topical      Teva Pharmaceuticals
                             Solution USP, 0.05%.   USA.
ANDA 074899...............  Etodolac Capsules      ANI Pharmaceuticals,
                             USP, 200 mg and 300    Inc.
                             mg.
ANDA 074920...............  Clonazepam Tablets     Teva Pharmaceuticals
                             USP, 0.5 mg, 1 mg,     USA.
                             and 2 mg.

[[Page 61429]]

 
ANDA 075020...............  Hydroxyurea Capsule    Barr Laboratories,
                             USP, 250 mg and 500    Inc., Subsidiary of
                             mg.                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 075055...............  Captopril and          Ivax Pharmaceuticals,
                             Hydrochlorothiazide    Inc.
                             Tablets USP, 25/15
                             mg, 25/25 mg, 50/15
                             mg, and 50/25 mg.
ANDA 075110...............  Cimetidine HCl         ANI Pharmaceuticals,
                             Solution, 300 mg/5     Inc.
                             mL.
ANDA 075448...............  Isosorbide             Ivax Pharmaceuticals,
                             Mononitrate Extended-  Inc.
                             Release Tablets, 30
                             mg, 60 mg, and 120
                             mg.
ANDA 075482...............  Enalapril Maleate      Do.
                             Tablets USP, 2.5 mg,
                             5 mg, 10 mg, and 20
                             mg.
ANDA 075734...............  Hydroxyurea Tablets    Barr Laboratories,
                             USP, 1,000 mg.         Inc., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 075763...............  Nefazodone HCl         Ivax Pharmaceuticals,
                             Tablets USP, 50 mg,    Inc.
                             100 mg, 150 mg, 200
                             mg, and 250 mg.
ANDA 076136...............  Ciprofloxacin Tablets  Teva Pharmaceuticals
                             USP, 250 mg, 500 mg,   USA.
                             and 750 mg.
ANDA 076169...............  Fexofenadine HCl       Barr Laboratories,
                             Capsules, 60 mg.       Inc., 400 Chestnut
                                                    Ridge Rd., Woodcliff
                                                    Lake, NJ 07677.
ANDA 076752...............  Levothyroxine Sodium   Merck KGaA, c/o Icon
                             Tablets USP, 25 mcg,   Clinical Research,
                             50 mcg, 75 mcg, 88     212 Church Rd.,
                             mcg, 100 mcg, 112      North Wales, PA
                             mcg, 125 mcg, 150      19454.
                             mcg, 175 mcg, 200
                             mcg, and 300 mcg.
ANDA 076988...............  Prednisolone Sodium    Nesher
                             Phosphate Oral         Pharmaceuticals
                             Solution USP,          (USA) LLC, 13910
                             Prednisolone Base 15   Saint Charles Rock
                             mg/5 mL.               Rd., Bridgeton, MO
                                                    63044.
ANDA 077176...............  Metoprolol Succinate   Do.
                             Extended-Release
                             Tablets, 50 mg.
ANDA 077779...............  Metoprolol Sucinate    Do.
                             Extended-Release
                             Tablets, 25 mg.
ANDA 080391...............  Edetate Calcium        Watson Laboratories,
                             Disodium Injection.    Inc., Morris
                                                    Corporate Center
                                                    III, 400 Interpace
                                                    Parkway, Parsippany,
                                                    NJ 07054.
ANDA 080505...............  Carmol HC Cream......  Fougera
                                                    Pharmaceuticals
                                                    Inc., 60 Baylis Rd.,
                                                    P.O. Box 2006,
                                                    Melville, NY 11747.
ANDA 080701...............  Prednisone Tablets     Mutual Pharmaceutical
                             USP, 5 mg.             Co., Inc.
ANDA 081054...............  Hydroxyzine HCl        Pliva, Inc.,
                             Tablets, 100 mg.       Subsidiary of Teva
                                                    Pharmaceuticals USA.
ANDA 083729...............  Imipramine HCl         Teva Pharmaceuticals
                             Tablets USP, 10 mg,    USA.
                             25 mg, and 50 mg.
ANDA 083734...............  Probenecid and         Ivax Pharmaceuticals,
                             Colchicine Tablets     Inc.
                             USP, 500 mg/0.5 mg.
ANDA 083740...............  Probenecid Tablets     Do.
                             USP, 500 mg.
ANDA 084106...............  Hydralazine HCl        Mutual Pharmaceutical
                             Tablets USP, 25 mg.    Co., Inc.
ANDA 084107...............  Hydralazine HCl        Do.
                             Tablets USP, 50 mg.
ANDA 084506...............  Diphenhydramine HCl    Do.
                             Capsules USP, 25 mg.
ANDA 084595...............  Procainainde HCl       Ivax Pharmaceuticals,
                             Capsules USP, 375 mg.  Inc.
ANDA 084606...............  Procainamide HCl       Do.
                             Capsules USP, 500 mg.
ANDA 084634...............  Prednisone Tablets     Mutual Pharmaceutical
                             USP, 20 mg.            Co., Inc.
ANDA 084978...............  Micrainin (aspirin     Meda Pharmaceuticals
                             and meprobamate)       Inc.
                             Tablets, 325 mg/200
                             mg.
ANDA 085627...............  Amitriptyline HCl      Mutual Pharmaceutical
                             Tablets USP, 25 mg.    Co., Inc.
ANDA 085742...............  Amitriptyline HCl      Do.
                             Tablets USP, 100 mg.
ANDA 085743...............  Amitriptyline HCl      Do.
                             Tablets USP, 75 mg.
ANDA 085744...............  Amitriptyline HCl      Do.
                             Tablets USP, 10 mg.
ANDA 085745...............  Amitriptyline HCl      Do.
                             Tablets USP, 50 mg.
ANDA 085836...............  Amitriptyline HCl      Teva Pharmaceuticals
                             Tablets USP, 100 mg.   USA.
ANDA 086595...............  Prednisone Tablets     Mutual Pharmaceutical
                             USP, 10 mg.            Co., Inc.
ANDA 087265...............  Spironolactone         Do.
                             Tablets USP, 25 mg.
ANDA 087267...............  Spironolactone and     Do.
                             Hydrochlorothiazide
                             Tablets USP, 25 mg/
                             25 mg.
ANDA 087292...............  Chlorthalidone         Do.
                             Tablets USP, 25 mg.
ANDA 087293...............  Chlorthalidone         Do.
                             Tablets USP, 50 mg.
ANDA 087857...............  Hydroxyzine HCl        Do.
                             Tablets USP, 25 mg.
ANDA 087860...............  Hydroxyzine HCl        Do.
                             Tablets USP, 50 mg.
ANDA 087913...............  Methyclothiazide       Ivax Pharmaceuticals,
                             Tablets USP, 2.5 mg.   Inc.
ANDA 088409...............  Hydroxyzine HCl        Mutual Pharmaceutical
                             Tablets USP, 10 mg.    Co., Inc.
ANDA 088626...............  Bromodiphenhydramine   Wockhardt Bio AG, c/o
                             HCl and Codeine        Morton Grove
                             Phosphate Syrup,       Pharmaceuticals,
                             12.5 mg/5 mL and 10    Inc., 6451 Main St.,
                             mg/5 mL.               Morton Grove, IL
                                                    60053.
ANDA 088728...............  Hydralazine HCl        Mutual Pharmaceutical
                             Tablets USP, 10 mg.    Co., Inc.
ANDA 088804...............  Trimethobenzamide HCl  Hospira, Inc.
                             Injection USP, 100
                             mg/mL.
ANDA 088883...............  Amitriptyline HCl      Pliva, Inc.,
                             Tablets USP, 10 mg.    Subsidiary of Teva
                                                    Pharmaceuticals USA.
ANDA 088884...............  Amitriptyline HCl      Pliva Hrvatska
                             Tablets USP, 25 mg.    d.o.o., Subsidiary
                                                    of Teva
                                                    Pharmaceuticals USA,
                                                    425 Privet Rd.,
                                                    Horsham, PA 19044.
ANDA 088885...............  Amitriptyline HCl      Pliva, Inc.,
                             Tablets USP, 50 mg.    Subsidiary of Teva
                                                    Pharmaceuticals USA.
ANDA 088886...............  Amitriptyline HCl      Do.
                             Tablets USP, 75 mg.
ANDA 088887...............  Amitriptyline HCl      Do.
                             Tablets USP, 100 mg.
ANDA 088888...............  Amitriptyline HCl      Pliva Hrvatska
                             Tablets USP, 150 mg.   d.o.o., Subsidiary
                                                    of Teva
                                                    Pharmaceuticals USA.
ANDA 088891...............  Ergoloid Mesylates     Mutual Pharmaceutical
                             Tablets USP, 1 mg.     Co., Inc.

[[Page 61430]]

 
ANDA 089238...............  Acetaminophen and      Mikart, Inc., 1750
                             Codeine Phosphate      Chattahoochee Ave.,
                             Tablets USP, 300 mg/   Atlanta, GA 30318.
                             30 mg.
ANDA 089244...............  Acetaminophen and      Do.
                             Codeine Phosphate
                             Tablets USP, 300 mg/
                             60 mg.
ANDA 089423...............  Amitriptyline HCl      Mutual Pharmaceutical
                             Tablets USP, 150 mg.   Co., Inc.
ANDA 090849...............  Oxaliplatin for        Sandoz Inc., 506
                             Injection USP, 50 mg/  Carnegie Center,
                             vial and 100 mg/vial.  Suite 400,
                                                    Princeton, NJ 08540.
------------------------------------------------------------------------

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director of Food and Drugs, Center for Drug Evaluation and Research, by 
the Commissioner, approval of the applications listed in table 1 in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective November 12, 2015. Introduction or delivery for 
introduction into interstate commerce of products without approved new 
drug applications violates section 301(a) and (d) of the Act (21 U.S.C. 
331(a) and (d)). Drug products that are listed in table 1 that are in 
inventory on the date that this notice becomes effective (see the DATES 
section) may continue to be dispensed until the inventories have been 
depleted or the drug products have reached their expiration dates or 
otherwise become violative, whichever occurs first.

    Dated: October 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25922 Filed 10-9-15; 8:45 am]
 BILLING CODE 4164-01-P