| Page Range | 61426-61430 | |
| FR Document | 2015-25922 |
[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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Effective Date: November 12, 2015. | |
| 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. | |
| FR Citation | 80 FR 61426 |