80_FR_61623 80 FR 61426 - Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications

80 FR 61426 - Organon USA Inc. et al.; Withdrawal of Approval of 67 New Drug Applications and 128 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 197 (October 13, 2015)

Page Range61426-61430
FR Document2015-25922

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Federal Register, Volume 80 Issue 197 (Tuesday, October 13, 2015) 
[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Notices]
[Pages 61426-61430]
From the Federal Register Online  [www.thefederalregister.org]
[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be withdrawn.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

61426 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices Desk Officer for the Administration for ACTION: Notice. Silver Spring, MD 20993–0002, 301– Children and Families. 796–3601. SUMMARY: The Food and Drug Robert Sargis, SUPPLEMENTARY INFORMATION: The Administration (FDA) is withdrawing Reports Clearance Officer. approval of 67 new drug applications holders of the applications listed in [FR Doc. 2015–25924 Filed 10–9–15; 8:45 am] (NDAs) and 128 abbreviated new drug table 1 in this document have informed BILLING CODE 4184–01–P applications (ANDAs) from multiple FDA that these drug products are no applicants. The holders of the longer marketed and have requested that applications notified the Agency in FDA withdraw approval of the DEPARTMENT OF HEALTH AND writing that the drug products were no applications under the process in HUMAN SERVICES longer marketed and requested that the § 314.150(c) (21 CFR 314.150(c)). The Food and Drug Administration approval of the applications be applicants have also, by their requests, withdrawn. waived their opportunity for a hearing. [Docket No. FDA–2015–N–3432] Withdrawal of approval of an DATES: Effective Date: November 12, application or abbreviated application Organon USA Inc. et al.; Withdrawal of 2015. under § 314.150(c) is without prejudice Approval of 67 New Drug Applications FOR FURTHER INFORMATION CONTACT: to refiling. and 128 Abbreviated New Drug Florine P. Purdie, Center for Drug Applications Evaluation and Research, Food and AGENCY: Food and Drug Administration, Drug Administration, 10903 New HHS. Hampshire Ave., Bldg. 51, Rm. 6248, TABLE 1 Application No. Drug Applicant NDA 001104 ............ Doca (desoxycorticosterone acetate) Injection, 5 milligrams Organon USA Inc., Subsidiary of Merck Sharp & Dohme (mg)/milliliter (mL). Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. NDA 004589 ............ Alcohol in Dextrose Injection USP, 10 mL/100 mL and 5 B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA grams (g)/100 mL. 18109. NDA 006170 ............ Hyprotigen (modified protein hydrolysate) Injection, 5% ...... Do. NDA 012154 ............ Ureaphil (urea) for Injection, 40 g/vial ................................... Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045. NDA 012449 ............ Oratrol (dichlorphenamide) Tablets, 50 mg .......................... Alcon Laboratories Inc., 6201 South Freeway, P.O. Box 1959, Fort Worth, TX 76134. NDA 012699 ............ Lomotil (atropine sulfate and diphenoxylate hydrochloride G.D. Searle, LLC, 235 East 42nd St., New York, NY (HCl)) Solution 0.025 mg/5 mL and 2.5 mg/5 mL. 10017. NDA 012892 ............ Uracil Mustard Capsule ......................................................... Shire Development Inc., 725 Chesterbrook Blvd., Wayne, PA 19087–5637. NDA 014738 ............ Mannitol Injection USP, 20% ................................................. B. Braun Medical Inc. NDA 016080 ............ Mannitol Injection USP .......................................................... Do. NDA 016096 ............ Mintezol (thiabendazole) Tablets .......................................... Merck Sharp & Dohme Corp., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889. NDA 016097 ............ Mintezol (thiabendazole) Oral Suspension ........................... Do. NDA 016695 ............ Dextrose Injection, 5% (in Ringer’s) ...................................... Baxter Healthcare Corp. 32650 N. Wilson Rd., Round Lake, IL 60073. NDA 017390 ............ Plasma-Lyte M and Dextrose 5% Injection ........................... Do. NDA 017438 ............ Plasma-Lyte R Injection ........................................................ Do. NDA 017451 ............ Plasma Lyte 148 and Dextrose 5% Injection ........................ Do. NDA 017493 ............ Travasol (amino acids) Injection, 10% .................................. Do. NDA 017510 ............ Dextrose 5% Injection (in lactated Ringer’s) ......................... B. Braun Medical Inc. NDA 017636 ............ Sorbitol-Mannitol Irrigation, 2.7 g/100 mL–540 mg/100 mL .. Hospira, Inc. NDA 017698 ............ Serile Urea Injection .............................................................. Do. NDA 017911 ............ Clinoril (sulindac) Tablets, 150 mg and 200 mg ................... Merck Sharp & Dohme Corp. NDA 017957 ............ Novamine (amino acids) Injection ......................................... Hospira, Inc. NDA 017995 ............ Dextrose Injection USP, 60% ................................................ B. Braun Medical Inc. NDA 018191 ............ Drixoral Non-Drowsy (pseudoephedrine sulfate) Extended- MSD Consumer Care, Inc., 556 Morris Ave., Summit, NJ Release Tablets, 120 mg. 07901. NDA 018242 ............ Sulfamethoxazole and Trimethorim Tablets USP ................. Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. NDA 018258 ............ Dextrose Injection 5% (in acetated Ringer’s) ........................ B. Braun Medical Inc. NDA 018268 ............ Dextrose, Sodium Chloride, and Potassium Chloride Injec- Do. tion USP, 5%. NDA 018307 ............ Thyro-Block (potassium iodide tablets USP) ........................ Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. NDA 018308 ............ Thyro-Block (potassium iodide solution), 21 mg ................... Do. NDA 018312 ............ Calderol (calcifediol) Capsules .............................................. Organon USA Inc., Subsidiary of Merck & Co., Inc. mstockstill on DSK4VPTVN1PROD with NOTICES NDA 018376 ............ Dextrose and Sodium Chloride Injection, 2.5%/0.9% ........... B. Braun Medical Inc. NDA 018531 ............ Nitroglycerin Injection USP, 5 mg/mL ................................... Hospira, Inc. NDA 018533 ............ Nizoral (ketoconazole) Tablets, 200 mg ............................... Janssen Pharmaceuticals, Inc., c/o Janssen Research & Development, LLC, 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869–0602. NDA 018684 ............ Branchamin (amino acids) Injection, 4% ............................... Baxter Healthcare Corp. NDA 018722 ............ Sodium Chloride 0.9%, and Potassium Chloride Injection ... B. Braun Medical Inc. NDA 018725 ............ Acetated Ringer’s Injection .................................................... Do. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00093 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61427 TABLE 1—Continued Application No. Drug Applicant NDA 018744 ............ Dextrose and Potassium Chloride Injection .......................... Do. NDA 018818 ............ Metronidazole Tablets USP, 250 mg and 500 mg ................ Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Phila- delphia, PA 19124. NDA 018840 ............ Dextrose 5%, and Electrolyte No. 75 Injection ..................... Baxter Healthcare Corp. NDA 019037 ............ Imodium (loperamide HCl) Oral Solution, 1 mg/5 mL ........... Janssen Pharmaceuticals, Inc., c/o Janssen Research & Development, LLC, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560. NDA 019047 ............ Plasma-Lyte 56 (electrolyte solution) Injection ..................... Baxter Healthcare Corp. NDA 019439 ............ K-Dur (potassium chloride) Extended-Release Tablets, 10 Merck Sharp & Dohme Corp. milliequivalents (mEq) and 20 mEq. NDA 019645 ............ Toradol (ketorolac tromethamine) Tablets, 10 mg ................ Roche Palo Alto LLC, c/o Genetech, Inc., 1 DNA Way, South San Francisco, CA 94080–4990. NDA 019681 ............ Aminosyn II in Dextrose Injection .......................................... Hospira, Inc. NDA 019682 ............ Aminosyn II with Electrolytes and Adjusted Phosphate in Do. Dextrose Injection. NDA 019683 ............ Aminosyn II with Electrolytes in Dextrose with Calcium In- Do. jection. NDA 019718 ............ Isolyte E (multi-electrolyte) Injection ..................................... B. Braun Medical Inc. NDA 019778 ............ Prinzide (lisinopril and hydrochlorothiazide) Tablets, 10 mg/ Merck Sharp & Dohme Corp. 12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. NDA 019843 ............ Isolyte S (multi-electrolyte) in Dextrose 5% Injection ........... B. Braun Medical Inc. NDA 019864 ............ Isolyte R (multi-electrolyte) in Dextrose 5% Injection ........... Do. NDA 019867 ............ Isolyte E (multi-electrolyte) in Dextrose 5% Injection ........... Do. NDA 020004 ............ Sodium Lactate Injection USP, 1/6 molar ............................. Do. NDA 020173 ............ Travasol (amino acids) Injection With Electrolytes in Dex- Baxter Healthcare Corp. trose. NDA 020177 ............ Travasol (amino acids) Injection With Electrolytes ............... Do. NDA 020536 ............ Nicotrol (nicotine transdermal system), 15 mg ..................... McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034. NDA 020004 ............ Sodium Lactate Injection USP, 1/6 molar ............................. B. Braun Medical Inc. NDA 020173 ............ Travasol (amino acids) Injection With Electrolytes in Dex- Baxter Healthcare Corp. trose. NDA 020177 ............ Travasol (amino acids) Injection With Electrolytes ............... Do. NDA 020811 ............ Acular PF (ketorolac tromethamine) Ophthalmic Solution, Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 0.5%. 92623–9534. NDA 021260 ............ Avinza (morphine sulfate) Extended-Release Capsules ....... King Pharmaceuticals LLC, 235 East 42nd St., New York, NY 10017. NDA 021415 ............ Metvixia (methyl aminolevulinate HCl) Cream, 16.8% .......... Galderma Laboratories, L.P., 14501 North Freeway, Fort Worth, TX 76177. NDA 021460 ............ Metaglip (glipizide and metformin HCl) Tablets, 2.5 mg/250 Bristol-Myers Squibb, P.O. Box 4000 (Mailstop D12–02), mg, 2.5 mg/500 mg, and 5 mg/500 mg. Princeton, NJ 08543–4000. NDA 021788 ............ Synthetic Conjugated Estrogens, A Vaginal Cream, 0.625 Teva Women’s Health, Inc., 41 Moores Rd., P.O. Box mg/gram (g). 4011, Frazer, PA 19355. NDA 021961 ............ Simvastatin Orally Disintegrating Tablets, 10 mg, 20 mg, 40 Synthon Pharmaceuticals, Inc., 9000 Development Dr., mg, and 80 mg. P.O. Box 110487, Research Triangle Park, NC 27709. ANDA 040093 ......... Digoxin Injection USP Carpuject, 250 micrograms (mcg)/mL Hospira, Inc. ANDA 040233 ......... Methotrexate Tablets USP, 2.5 mg ....................................... Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 040285 ......... Hydrocodone Bitartrate and Homatropine Methylbromide Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharma- Syrup, 5 mg/5 mL and 1.5 mg/5 mL. ceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 040287 ......... Prednisolone Syrup, 15 mg/5 mL .......................................... Do. ANDA 040435 ......... Extended Phenytoin Sodium Capsules USP, 100 mg .......... ANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 56623. ANDA 040443 ......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Watson Laboratories, Inc.—Florida, 2945 West Corporate mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg. Lakes Blvd., Suite B, Weston, FL 33331. NDA 050336 ............ Tao (troleandomycin) Capsule .............................................. Pfizer, Inc., 235 East 42nd St., New York, NY 10017. NDA 050520 ............ Spectrobid (bacampicillin HCl) Tablets ................................. Do. NDA 050556 ............ Spectrobid (bacampicillin HCl) Oral Suspension .................. Do. NDA 050809 ............ Azithromycin for Injection, 500 mg/vial and 2.5 g/vial .......... Teva Parenteral Medicines, Inc., Subsidiary of Teva Phar- maceuticals USA, 19 Hughes, Irvine, CA 92618–1902. ANDA 061370 ......... Ampicillin Trihydrate for Oral Suspension, 125 mg/5 mL, Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA mstockstill on DSK4VPTVN1PROD with NOTICES 250 mg/5 mL. 19044. ANDA 061461 ......... Erythromycin Stearate Tablets USP, 250 mg and 500 mg .. ANI Pharmaceuticals, Inc. ANDA 062338 ......... Eryc (erythromycin delayed-release capsules USP), 250 Warner Chilcott (US) Inc., 100 Enterprise Dr., Rockaway, mg. NJ 07866. ANDA 062391 ......... Doxycycline Hyclate Tablets USP, 100 mg .......................... Mutual Pharmaceutical Co., Inc. ANDA 062418 ......... Doxycycline Hyclate Capsules USP, 50 mg and 100 mg ..... Do. ANDA 062645 ......... Griseofulvin Tablets USP, 165 mg ........................................ Barr Laboratories, Inc. ANDA 062646 ......... Ultramicrosize Griseofulvin Tablets USP, 330 mg ................ Do. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00094 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

61428 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices TABLE 1—Continued Application No. Drug Applicant ANDA 062777 ......... Cephalexin for Oral Suspension USP, 250 mg/5 mL ........... Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. ANDA 062778 ......... Cephalexin for Oral Suspension USP, 125 mg/5 mL ........... Do. ANDA 062826 ......... Cephalexin Tablets USP, 250 mg ......................................... Do. ANDA 062827 ......... Cephalexin Tablets USP, 500 mg ......................................... Do. ANDA 062895 ......... Cyclacillin Tablets, 250 mg and 500 mg ............................... Teva Pharmaceuticals, USA. ANDA 062930 ......... Clindamycin Phosphate Topical Solution, 1% ...................... Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811. ANDA 064061 ......... Cefaclor Capsules USP, 250 mg and 500 mg ...................... Ivax Pharmaceuticals, Inc. ANDA 064070 ......... Cefaclor Oral Suspension USP, 375 mg/5 mL ..................... Do. ANDA 064085 ......... Cefaclor Oral Suspension USP, 250 mg/5 mL ..................... Do. ANDA 064086 ......... Cefaclor Oral Suspension UPS, 187 mg/5 mL ..................... Do. ANDA 064087 ......... Cefaclor Oral Suspension USP, 125 mg/5 mL ..................... Do. ANDA 065297 ......... Azithromycin for Oral Suspension, 100 mg/5 mL and 200 Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893. mg/5 mL. ANDA 070067 ......... Indomethacin Capsules USP, 25 mg .................................... Mutual Pharmaceutical Co., Inc. ANDA 070068 ......... Indomethacin Capsules USP, 50 mg .................................... Do. ANDA 070081 ......... Ibuprofen Tablets, 400 mg .................................................... McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034. ANDA 070215 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/ Pliva Inc., Subsidiary of Teva Pharmaceuticals USA, 425 80 mg. Privet Rd., Horsham, PA 19044. ANDA 070466 ......... Allopurinol Tablets USP, 100 mg .......................................... Mutual Pharmaceutical Co., Inc. ANDA 070467 ......... Allopurinol Tablets USP, 300 mg .......................................... Do. ANDA 070472 ......... Lorazepam Tablets USP, 0.5 mg .......................................... Do. ANDA 070473 ......... Lorazepam Tablets USP, 1 mg ............................................. Do. ANDA 070474 ......... Lorazepam Tablets USP, 2 mg ............................................. Do. ANDA 070482 ......... Verapamil HCl Tablets, 80 mg .............................................. Do. ANDA 070483 ......... Verapamil HCl Tablets, 120 mg ............................................ Do. ANDA 070578 ......... Furosemide Injection USP, 10 mg/mL .................................. Hospira, Inc. ANDA 070795 ......... Amiloride HCl and Hydrochlorothiazide Tablets USP, 5 mg/ Teva Pharmaceuticals USA. 50 mg. ANDA 070819 ......... Metoclopramide Oral Solution USP, 5 mg/5 mL ................... Do. ANDA 071259 ......... Trimethoprim Tablets, 200 mg .............................................. Do. ANDA 071315 ......... Metoclopramide Oral Solution USP, 5 mg/5 mL ................... Do. ANDA 071769 ......... Ibuprofen Tablets USP, 800 mg ............................................ Ivax Pharmaceuticals, Inc. ANDA 072126 ......... Methyldopa Tablets, 125 mg ................................................. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 072127 ......... Methyldopa Tablets, 250 mg ................................................. Do. ANDA 072128 ......... Methyldopa Tablets, 500 mg ................................................. Do. ANDA 072557 ......... Fenoprofen Calcium Tablets USP, 600 mg .......................... Ivax Pharmaceuticals, Inc. ANDA 072779 ......... Albuterol Tablets USP, 2 mg ................................................. Teva Pharmaceuticals USA. ANDA 072780 ......... Albuterol Tablets USP, 4 mg ................................................. Do. ANDA 073115 ......... Amantadine HCl Oral Solution USP, 50 mg/5 mL ................ Do. ANDA 073478 ......... Loperamide HCl Oral Solution, 1 mg/5 mL ........................... Do. ANDA 073497 ......... Lactulose Solution USP, 10 g/15 mL (Evalose) .................... Do. ANDA 073504 ......... Lactulose Solution USP, 10 g/15 mL (Heptalac) .................. Do. ANDA 074101 ......... Atenolol Tablets, 25 mg, 50 mg, and 100 mg ...................... Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA. ANDA 074103 ......... Piroxicam Capsules USP, 10 mg and 20 mg ....................... Teva Pharmaceuticals USA. ANDA 074148 ......... Piroxicam Capsules USP, 10 mg and 20 mg ....................... Ivax Pharmaceuticals, Inc. ANDA 074344 ......... Cimetidine Injection USP, 300 mg/2 mL ............................... Hospira, Inc. ANDA 074345 ......... Cimetidine Injection USP, 300 mg/2 mL ............................... Do. ANDA 074347 ......... Cholestyramine for Oral Suspension USP, 4 g .................... Teva Pharmaceuticals USA. ANDA 074348 ......... Cholestyramine for Oral Suspension USP, 4 g .................... Do. ANDA 074368 ......... Nadolol Tablets USP, 80 mg, 120 mg, and 160 mg ............. Do. ANDA 074390 ......... Diclofenac Sodium Delayed-Release Tablets USP, 75 mg .. Do. ANDA 074401 ......... Cimetidine Tablets USP, 200 mg, 300 mg, and 400 mg ...... Ivax Pharmaceuticals, Inc. ANDA 074402 ......... Cimetidine Tablets USP, 800 mg .......................................... Do. ANDA 074411 ......... Flurbiprofen Tablets USP, 50 mg and 100 mg ..................... Do. ANDA 074500 ......... Minoxidil Topical Solution, 2% .............................................. Copley Pharmaceutical, Inc., Subsidiary of Teva Pharma- ceuticals USA, 425 Privet Rd., Horsham, PA 19044. ANDA 074530 ......... Terazosin HCl Tablets, 1 mg, 2 mg, 5 mg, and 10 mg ........ Ivax Pharmaceuticals, Inc. ANDA 074590 ......... Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 Do. mstockstill on DSK4VPTVN1PROD with NOTICES mg. ANDA 074619 ......... Glipizide Tablets USP, 5 mg and 10 mg .............................. Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 074859 ......... Cimetidine HCl Oral Solution, 300 mg/5 mL ......................... ANI Pharmaceuticals, Inc. ANDA 074873 ......... Tretinoin Topical Solution USP, 0.05% ................................. Teva Pharmaceuticals USA. ANDA 074899 ......... Etodolac Capsules USP, 200 mg and 300 mg ..................... ANI Pharmaceuticals, Inc. ANDA 074920 ......... Clonazepam Tablets USP, 0.5 mg, 1 mg, and 2 mg ............ Teva Pharmaceuticals USA. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00095 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices 61429 TABLE 1—Continued Application No. Drug Applicant ANDA 075020 ......... Hydroxyurea Capsule USP, 250 mg and 500 mg ................ Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 075055 ......... Captopril and Hydrochlorothiazide Tablets USP, 25/15 mg, Ivax Pharmaceuticals, Inc. 25/25 mg, 50/15 mg, and 50/25 mg. ANDA 075110 ......... Cimetidine HCl Solution, 300 mg/5 mL ................................. ANI Pharmaceuticals, Inc. ANDA 075448 ......... Isosorbide Mononitrate Extended-Release Tablets, 30 mg, Ivax Pharmaceuticals, Inc. 60 mg, and 120 mg. ANDA 075482 ......... Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and Do. 20 mg. ANDA 075734 ......... Hydroxyurea Tablets USP, 1,000 mg ................................... Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 075763 ......... Nefazodone HCl Tablets USP, 50 mg, 100 mg, 150 mg, Ivax Pharmaceuticals, Inc. 200 mg, and 250 mg. ANDA 076136 ......... Ciprofloxacin Tablets USP, 250 mg, 500 mg, and 750 mg .. Teva Pharmaceuticals USA. ANDA 076169 ......... Fexofenadine HCl Capsules, 60 mg ..................................... Barr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677. ANDA 076752 ......... Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 Merck KGaA, c/o Icon Clinical Research, 212 Church Rd., mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg, North Wales, PA 19454. 175 mcg, 200 mcg, and 300 mcg. ANDA 076988 ......... Prednisolone Sodium Phosphate Oral Solution USP, Pred- Nesher Pharmaceuticals (USA) LLC, 13910 Saint Charles nisolone Base 15 mg/5 mL. Rock Rd., Bridgeton, MO 63044. ANDA 077176 ......... Metoprolol Succinate Extended-Release Tablets, 50 mg ..... Do. ANDA 077779 ......... Metoprolol Sucinate Extended-Release Tablets, 25 mg ....... Do. ANDA 080391 ......... Edetate Calcium Disodium Injection ..................................... Watson Laboratories, 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 USP, 5 mg ............................................. Mutual Pharmaceutical Co., Inc. ANDA 081054 ......... Hydroxyzine HCl Tablets, 100 mg ........................................ Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA. ANDA 083729 ......... Imipramine HCl Tablets USP, 10 mg, 25 mg, and 50 mg .... Teva Pharmaceuticals USA. ANDA 083734 ......... Probenecid and Colchicine Tablets USP, 500 mg/0.5 mg ... Ivax Pharmaceuticals, Inc. ANDA 083740 ......... Probenecid Tablets USP, 500 mg ......................................... Do. ANDA 084106 ......... Hydralazine HCl Tablets USP, 25 mg ................................... Mutual Pharmaceutical Co., Inc. ANDA 084107 ......... Hydralazine HCl Tablets USP, 50 mg ................................... Do. ANDA 084506 ......... Diphenhydramine HCl Capsules USP, 25 mg ...................... Do. ANDA 084595 ......... Procainainde HCl Capsules USP, 375 mg ........................... Ivax Pharmaceuticals, Inc. ANDA 084606 ......... Procainamide HCl Capsules USP, 500 mg .......................... Do. ANDA 084634 ......... Prednisone Tablets USP, 20 mg ........................................... Mutual Pharmaceutical Co., Inc. ANDA 084978 ......... Micrainin (aspirin and meprobamate) Tablets, 325 mg/200 Meda Pharmaceuticals Inc. mg. ANDA 085627 ......... Amitriptyline HCl Tablets USP, 25 mg .................................. Mutual Pharmaceutical Co., Inc. ANDA 085742 ......... Amitriptyline HCl Tablets USP, 100 mg ................................ Do. ANDA 085743 ......... Amitriptyline HCl Tablets USP, 75 mg .................................. Do. ANDA 085744 ......... Amitriptyline HCl Tablets USP, 10 mg .................................. Do. ANDA 085745 ......... Amitriptyline HCl Tablets USP, 50 mg .................................. Do. ANDA 085836 ......... Amitriptyline HCl Tablets USP, 100 mg ................................ Teva Pharmaceuticals USA. ANDA 086595 ......... Prednisone Tablets USP, 10 mg ........................................... Mutual Pharmaceutical Co., Inc. ANDA 087265 ......... Spironolactone Tablets USP, 25 mg ..................................... Do. ANDA 087267 ......... Spironolactone and Hydrochlorothiazide Tablets USP, 25 Do. mg/25 mg. ANDA 087292 ......... Chlorthalidone Tablets USP, 25 mg ...................................... Do. ANDA 087293 ......... Chlorthalidone Tablets USP, 50 mg ...................................... Do. ANDA 087857 ......... Hydroxyzine HCl Tablets USP, 25 mg .................................. Do. ANDA 087860 ......... Hydroxyzine HCl Tablets USP, 50 mg .................................. Do. ANDA 087913 ......... Methyclothiazide Tablets USP, 2.5 mg ................................. Ivax Pharmaceuticals, Inc. ANDA 088409 ......... Hydroxyzine HCl Tablets USP, 10 mg .................................. Mutual Pharmaceutical Co., Inc. ANDA 088626 ......... Bromodiphenhydramine HCl and Codeine Phosphate Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Syrup, 12.5 mg/5 mL and 10 mg/5 mL. Inc., 6451 Main St., Morton Grove, IL 60053. ANDA 088728 ......... Hydralazine HCl Tablets USP, 10 mg ................................... Mutual Pharmaceutical Co., Inc. ANDA 088804 ......... Trimethobenzamide HCl Injection USP, 100 mg/mL ............ Hospira, Inc. ANDA 088883 ......... Amitriptyline HCl Tablets USP, 10 mg .................................. Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA. mstockstill on DSK4VPTVN1PROD with NOTICES ANDA 088884 ......... Amitriptyline HCl Tablets USP, 25 mg .................................. Pliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. ANDA 088885 ......... Amitriptyline HCl Tablets USP, 50 mg .................................. Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA. ANDA 088886 ......... Amitriptyline HCl Tablets USP, 75 mg .................................. Do. ANDA 088887 ......... Amitriptyline HCl Tablets USP, 100 mg ................................ Do. ANDA 088888 ......... Amitriptyline HCl Tablets USP, 150 mg ................................ Pliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceuticals USA. ANDA 088891 ......... Ergoloid Mesylates Tablets USP, 1 mg ................................ Mutual Pharmaceutical Co., Inc. VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00096 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1

61430 Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Notices TABLE 1—Continued Application No. Drug Applicant ANDA 089238 ......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318. mg/30 mg. ANDA 089244 ......... Acetaminophen and Codeine Phosphate Tablets USP, 300 Do. mg/60 mg. ANDA 089423 ......... Amitriptyline HCl Tablets USP, 150 mg ................................ Mutual Pharmaceutical Co., Inc. ANDA 090849 ......... Oxaliplatin for Injection USP, 50 mg/vial and 100 mg/vial .... Sandoz Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08540. Therefore, under section 505(e) of the information, including collections of Dockets Management (HFA–305), Food Federal Food, Drug, and Cosmetic Act information in current guidance and Drug Administration, 5630 Fishers (21 U.S.C. 355(e)) and under authority documents, and allow 60 days for Lane, Rm. 1061, Rockville, MD 20852. delegated to the Director of Food and public comment. This notice invites • For written/paper comments Drugs, Center for Drug Evaluation and comments on the recommended submitted to the Division of Dockets Research, by the Commissioner, recordkeeping associated with our draft Management, FDA will post your approval of the applications listed in guidance entitled, ‘‘Draft Guidance for comment, as well as any attachments, table 1 in this document, and all Industry: Cosmetic Good Manufacturing except for information submitted, amendments and supplements thereto, Practices.’’ Our draft guidance remains marked, and identified, as confidential, is hereby withdrawn, effective unchanged by this notice. We are if submitted as detailed in November 12, 2015. Introduction or publishing this notice in compliance ‘‘Instructions.’’ delivery for introduction into interstate with the PRA. This notice does not Instructions: All submissions received commerce of products without represent any new regulatory initiative. must include the Docket No. FDA– approved new drug applications DATES: Submit either electronic or 2015–N–3456 for ‘‘Agency Information violates section 301(a) and (d) of the Act written comments on the collection of Collection Activities; Proposed (21 U.S.C. 331(a) and (d)). Drug information by December 14, 2015. Collection; Comment Request; products that are listed in table 1 that ADDRESSES: You may submit comments Recommended Recordkeeping for are in inventory on the date that this as follows: Cosmetic Good Manufacturing notice becomes effective (see the DATES Practices.’’ Received comments will be section) may continue to be dispensed Electronic Submissions placed in the docket and, except for until the inventories have been depleted Submit electronic comments in the those submitted as ‘‘Confidential or the drug products have reached their following way: Submissions,’’ publicly viewable at expiration dates or otherwise become • Federal eRulemaking Portal: http:// http://www.regulations.gov or at the violative, whichever occurs first. www.regulations.gov. Follow the Division of Dockets Management Dated: October 6, 2015. instructions for submitting comments. between 9 a.m. and 4 p.m., Monday Comments submitted electronically, through Friday. Leslie Kux, • Confidential Submissions—To Associate Commissioner for Policy. including attachments, to http:// www.regulations.gov will be posted to submit a comment with confidential [FR Doc. 2015–25922 Filed 10–9–15; 8:45 am] information that you do not wish to be the docket unchanged. Because your BILLING CODE 4164–01–P comment will be made public, you are made publicly available, submit your solely responsible for ensuring that your comments only as a written/paper comment does not include any submission. You should submit two DEPARTMENT OF HEALTH AND copies total. One copy will include the HUMAN SERVICES confidential information that you or a third party may not wish to be posted, information you claim to be confidential such as medical information, your or with a heading or cover note that states Food and Drug Administration anyone else’s Social Security number, or ‘‘THIS DOCUMENT CONTAINS [Docket No. FDA–2015–N–3456] confidential business information, such CONFIDENTIAL INFORMATION’’. The as a manufacturing process. Please note Agency will review this copy, including Agency Information Collection the claimed confidential information, in Activities; Proposed Collection; that if you include your name, contact information, or other information that its consideration of comments. The Comment Request; Recommended second copy, which will have the Recordkeeping for Cosmetic Good identifies you in the body of your comments, that information will be claimed confidential information Manufacturing Practices redacted/blacked out, will be available posted on http://www.regulations.gov. AGENCY: Food and Drug Administration, • If you want to submit a comment for public viewing and posted on HHS. with confidential information that you http://www.regulations.gov. Submit ACTION: Notice. do not wish to be made available to the both copies to the Division of Dockets public, submit the comment as a Management. If you do not wish your SUMMARY: The Food and Drug written/paper submission and in the name and contact information to be mstockstill on DSK4VPTVN1PROD with NOTICES Administration (FDA or we) is manner detailed (see ‘‘Written/Paper made publicly available, you can announcing an opportunity for public Submissions’’ and ‘‘Instructions’’). provide this information on the cover comment on our proposed collection of sheet and not in the body of your certain information. Under the Written/Paper Submissions comments and you must identify this Paperwork Reduction Act of 1995 (the Submit written/paper submissions as information as ‘‘confidential.’’ Any PRA), Federal Agencies must publish a follows: information marked as ‘‘confidential’’ notice in the Federal Register • Mail/Hand delivery/Courier (for will not be disclosed except in concerning each proposed collection of written/paper submissions): Division of accordance with 21 CFR 10.20 and other VerDate Sep<11>2014 21:23 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\13OCN1.SGM 13OCN1


Document Created: 2018-02-27 08:48:07
Document Modified: 2018-02-27 08:48:07
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesEffective Date: November 12, 2015.
ContactFlorine 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.
FR Citation80 FR 61426 
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