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Notice

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

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Start Preamble

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

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 § 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 § 314.150(c) is without prejudice to refiling.

Table 1

Application No.DrugApplicant
NDA 001104Doca (desoxycorticosterone acetate) Injection, 5 milligrams (mg)/milliliter (mL)Organon USA Inc., Subsidiary of Merck Sharp & Dohme Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
NDA 004589Alcohol in Dextrose Injection USP, 10 mL/100 mL and 5 grams (g)/100 mLB. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 18109.
NDA 006170Hyprotigen (modified protein hydrolysate) Injection, 5%Do.
NDA 012154Ureaphil (urea) for Injection, 40 g/vialHospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
NDA 012449Oratrol (dichlorphenamide) Tablets, 50 mgAlcon Laboratories Inc., 6201 South Freeway, P.O. Box 1959, Fort Worth, TX 76134.
NDA 012699Lomotil (atropine sulfate and diphenoxylate hydrochloride (HCl)) Solution 0.025 mg/5 mL and 2.5 mg/5 mLG.D. Searle, LLC, 235 East 42nd St., New York, NY 10017.
NDA 012892Uracil Mustard CapsuleShire Development Inc., 725 Chesterbrook Blvd., Wayne, PA 19087-5637.
NDA 014738Mannitol Injection USP, 20%B. Braun Medical Inc.
NDA 016080Mannitol Injection USPDo.
NDA 016096Mintezol (thiabendazole) TabletsMerck Sharp & Dohme Corp., 1 Merck Drive, P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 016097Mintezol (thiabendazole) Oral SuspensionDo.
NDA 016695Dextrose Injection, 5% (in Ringer's)Baxter Healthcare Corp. 32650 N. Wilson Rd., Round Lake, IL 60073.
NDA 017390Plasma-Lyte M and Dextrose 5% InjectionDo.
NDA 017438Plasma-Lyte R InjectionDo.
NDA 017451Plasma Lyte 148 and Dextrose 5% InjectionDo.
NDA 017493Travasol (amino acids) Injection, 10%Do.
NDA 017510Dextrose 5% Injection (in lactated Ringer's)B. Braun Medical Inc.
NDA 017636Sorbitol-Mannitol Irrigation, 2.7 g/100 mL-540 mg/100 mLHospira, Inc.
NDA 017698Serile Urea InjectionDo.
NDA 017911Clinoril (sulindac) Tablets, 150 mg and 200 mgMerck Sharp & Dohme Corp.
NDA 017957Novamine (amino acids) InjectionHospira, Inc.
NDA 017995Dextrose Injection USP, 60%B. Braun Medical Inc.
NDA 018191Drixoral Non-Drowsy (pseudoephedrine sulfate) Extended-Release Tablets, 120 mgMSD Consumer Care, Inc., 556 Morris Ave., Summit, NJ 07901.
NDA 018242Sulfamethoxazole and Trimethorim Tablets USPTeva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
NDA 018258Dextrose Injection 5% (in acetated Ringer's)B. Braun Medical Inc.
NDA 018268Dextrose, Sodium Chloride, and Potassium Chloride Injection USP, 5%Do.
NDA 018307Thyro-Block (potassium iodide tablets USP)Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873.
NDA 018308Thyro-Block (potassium iodide solution), 21 mgDo.
NDA 018312Calderol (calcifediol) CapsulesOrganon USA Inc., Subsidiary of Merck & Co., Inc.
NDA 018376Dextrose and Sodium Chloride Injection, 2.5%/0.9%B. Braun Medical Inc.
NDA 018531Nitroglycerin Injection USP, 5 mg/mLHospira, Inc.
NDA 018533Nizoral (ketoconazole) Tablets, 200 mgJanssen Pharmaceuticals, Inc., c/o Janssen Research & Development, LLC, 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602.
NDA 018684Branchamin (amino acids) Injection, 4%Baxter Healthcare Corp.
NDA 018722Sodium Chloride 0.9%, and Potassium Chloride InjectionB. Braun Medical Inc.
NDA 018725Acetated Ringer's InjectionDo.
Start Printed Page 61427
NDA 018744Dextrose and Potassium Chloride InjectionDo.
NDA 018818Metronidazole Tablets USP, 250 mg and 500 mgMutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124.
NDA 018840Dextrose 5%, and Electrolyte No. 75 InjectionBaxter Healthcare Corp.
NDA 019037Imodium (loperamide HCl) Oral Solution, 1 mg/5 mLJanssen Pharmaceuticals, Inc., c/o Janssen Research & Development, LLC, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560.
NDA 019047Plasma-Lyte 56 (electrolyte solution) InjectionBaxter Healthcare Corp.
NDA 019439K-Dur (potassium chloride) Extended-Release Tablets, 10 milliequivalents (mEq) and 20 mEqMerck Sharp & Dohme Corp.
NDA 019645Toradol (ketorolac tromethamine) Tablets, 10 mgRoche Palo Alto LLC, c/o Genetech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990.
NDA 019681Aminosyn II in Dextrose InjectionHospira, Inc.
NDA 019682Aminosyn II with Electrolytes and Adjusted Phosphate in Dextrose InjectionDo.
NDA 019683Aminosyn II with Electrolytes in Dextrose with Calcium InjectionDo.
NDA 019718Isolyte E (multi-electrolyte) InjectionB. Braun Medical Inc.
NDA 019778Prinzide (lisinopril and hydrochlorothiazide) Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mgMerck Sharp & Dohme Corp.
NDA 019843Isolyte S (multi-electrolyte) in Dextrose 5% InjectionB. Braun Medical Inc.
NDA 019864Isolyte R (multi-electrolyte) in Dextrose 5% InjectionDo.
NDA 019867Isolyte E (multi-electrolyte) in Dextrose 5% InjectionDo.
NDA 020004Sodium Lactate Injection USP, 1/6 molarDo.
NDA 020173Travasol (amino acids) Injection With Electrolytes in DextroseBaxter Healthcare Corp.
NDA 020177Travasol (amino acids) Injection With ElectrolytesDo.
NDA 020536Nicotrol (nicotine transdermal system), 15 mgMcNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034.
NDA 020004Sodium Lactate Injection USP, 1/6 molarB. Braun Medical Inc.
NDA 020173Travasol (amino acids) Injection With Electrolytes in DextroseBaxter Healthcare Corp.
NDA 020177Travasol (amino acids) Injection With ElectrolytesDo.
NDA 020811Acular PF (ketorolac tromethamine) Ophthalmic Solution, 0.5%Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534.
NDA 021260Avinza (morphine sulfate) Extended-Release CapsulesKing Pharmaceuticals LLC, 235 East 42nd St., New York, NY 10017.
NDA 021415Metvixia (methyl aminolevulinate HCl) Cream, 16.8%Galderma Laboratories, L.P., 14501 North Freeway, Fort Worth, TX 76177.
NDA 021460Metaglip (glipizide and metformin HCl) Tablets, 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mgBristol-Myers Squibb, P.O. Box 4000 (Mailstop D12-02), Princeton, NJ 08543-4000.
NDA 021788Synthetic Conjugated Estrogens, A Vaginal Cream, 0.625 mg/gram (g)Teva Women's Health, Inc., 41 Moores Rd., P.O. Box 4011, Frazer, PA 19355.
NDA 021961Simvastatin Orally Disintegrating Tablets, 10 mg, 20 mg, 40 mg, and 80 mgSynthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709.
ANDA 040093Digoxin Injection USP Carpuject, 250 micrograms (mcg)/mLHospira, Inc.
ANDA 040233Methotrexate Tablets USP, 2.5 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 040285Hydrocodone Bitartrate and Homatropine Methylbromide Syrup, 5 mg/5 mL and 1.5 mg/5 mLIvax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 040287Prednisolone Syrup, 15 mg/5 mLDo.
ANDA 040435Extended Phenytoin Sodium Capsules USP, 100 mgANI Pharmaceuticals, Inc., 210 Main St. West, Baudette, MN 56623.
ANDA 040443Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mgWatson Laboratories, Inc.—Florida, 2945 West Corporate Lakes Blvd., Suite B, Weston, FL 33331.
NDA 050336Tao (troleandomycin) CapsulePfizer, Inc., 235 East 42nd St., New York, NY 10017.
NDA 050520Spectrobid (bacampicillin HCl) TabletsDo.
NDA 050556Spectrobid (bacampicillin HCl) Oral SuspensionDo.
NDA 050809Azithromycin for Injection, 500 mg/vial and 2.5 g/vialTeva Parenteral Medicines, Inc., Subsidiary of Teva Pharmaceuticals USA, 19 Hughes, Irvine, CA 92618-1902.
ANDA 061370Ampicillin Trihydrate for Oral Suspension, 125 mg/5 mL, 250 mg/5 mLTeva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 061461Erythromycin Stearate Tablets USP, 250 mg and 500 mgANI Pharmaceuticals, Inc.
ANDA 062338Eryc (erythromycin delayed-release capsules USP), 250 mgWarner Chilcott (US) Inc., 100 Enterprise Dr., Rockaway, NJ 07866.
ANDA 062391Doxycycline Hyclate Tablets USP, 100 mgMutual Pharmaceutical Co., Inc.
ANDA 062418Doxycycline Hyclate Capsules USP, 50 mg and 100 mgDo.
ANDA 062645Griseofulvin Tablets USP, 165 mgBarr Laboratories, Inc.
ANDA 062646Ultramicrosize Griseofulvin Tablets USP, 330 mgDo.
Start Printed Page 61428
ANDA 062777Cephalexin for Oral Suspension USP, 250 mg/5 mLBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 062778Cephalexin for Oral Suspension USP, 125 mg/5 mLDo.
ANDA 062826Cephalexin Tablets USP, 250 mgDo.
ANDA 062827Cephalexin Tablets USP, 500 mgDo.
ANDA 062895Cyclacillin Tablets, 250 mg and 500 mgTeva Pharmaceuticals, USA.
ANDA 062930Clindamycin Phosphate Topical Solution, 1%Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
ANDA 064061Cefaclor Capsules USP, 250 mg and 500 mgIvax Pharmaceuticals, Inc.
ANDA 064070Cefaclor Oral Suspension USP, 375 mg/5 mLDo.
ANDA 064085Cefaclor Oral Suspension USP, 250 mg/5 mLDo.
ANDA 064086Cefaclor Oral Suspension UPS, 187 mg/5 mLDo.
ANDA 064087Cefaclor Oral Suspension USP, 125 mg/5 mLDo.
ANDA 065297Azithromycin for Oral Suspension, 100 mg/5 mL and 200 mg/5 mLSandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 070067Indomethacin Capsules USP, 25 mgMutual Pharmaceutical Co., Inc.
ANDA 070068Indomethacin Capsules USP, 50 mgDo.
ANDA 070081Ibuprofen Tablets, 400 mgMcNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034.
ANDA 070215Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mgPliva Inc., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 070466Allopurinol Tablets USP, 100 mgMutual Pharmaceutical Co., Inc.
ANDA 070467Allopurinol Tablets USP, 300 mgDo.
ANDA 070472Lorazepam Tablets USP, 0.5 mgDo.
ANDA 070473Lorazepam Tablets USP, 1 mgDo.
ANDA 070474Lorazepam Tablets USP, 2 mgDo.
ANDA 070482Verapamil HCl Tablets, 80 mgDo.
ANDA 070483Verapamil HCl Tablets, 120 mgDo.
ANDA 070578Furosemide Injection USP, 10 mg/mLHospira, Inc.
ANDA 070795Amiloride HCl and Hydrochlorothiazide Tablets USP, 5 mg/50 mgTeva Pharmaceuticals USA.
ANDA 070819Metoclopramide Oral Solution USP, 5 mg/5 mLDo.
ANDA 071259Trimethoprim Tablets, 200 mgDo.
ANDA 071315Metoclopramide Oral Solution USP, 5 mg/5 mLDo.
ANDA 071769Ibuprofen Tablets USP, 800 mgIvax Pharmaceuticals, Inc.
ANDA 072126Methyldopa Tablets, 125 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 072127Methyldopa Tablets, 250 mgDo.
ANDA 072128Methyldopa Tablets, 500 mgDo.
ANDA 072557Fenoprofen Calcium Tablets USP, 600 mgIvax Pharmaceuticals, Inc.
ANDA 072779Albuterol Tablets USP, 2 mgTeva Pharmaceuticals USA.
ANDA 072780Albuterol Tablets USP, 4 mgDo.
ANDA 073115Amantadine HCl Oral Solution USP, 50 mg/5 mLDo.
ANDA 073478Loperamide HCl Oral Solution, 1 mg/5 mLDo.
ANDA 073497Lactulose Solution USP, 10 g/15 mL (Evalose)Do.
ANDA 073504Lactulose Solution USP, 10 g/15 mL (Heptalac)Do.
ANDA 074101Atenolol Tablets, 25 mg, 50 mg, and 100 mgPliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 074103Piroxicam Capsules USP, 10 mg and 20 mgTeva Pharmaceuticals USA.
ANDA 074148Piroxicam Capsules USP, 10 mg and 20 mgIvax Pharmaceuticals, Inc.
ANDA 074344Cimetidine Injection USP, 300 mg/2 mLHospira, Inc.
ANDA 074345Cimetidine Injection USP, 300 mg/2 mLDo.
ANDA 074347Cholestyramine for Oral Suspension USP, 4 gTeva Pharmaceuticals USA.
ANDA 074348Cholestyramine for Oral Suspension USP, 4 gDo.
ANDA 074368Nadolol Tablets USP, 80 mg, 120 mg, and 160 mgDo.
ANDA 074390Diclofenac Sodium Delayed-Release Tablets USP, 75 mgDo.
ANDA 074401Cimetidine Tablets USP, 200 mg, 300 mg, and 400 mgIvax Pharmaceuticals, Inc.
ANDA 074402Cimetidine Tablets USP, 800 mgDo.
ANDA 074411Flurbiprofen Tablets USP, 50 mg and 100 mgDo.
ANDA 074500Minoxidil Topical Solution, 2%Copley Pharmaceutical, Inc., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 074530Terazosin HCl Tablets, 1 mg, 2 mg, 5 mg, and 10 mgIvax Pharmaceuticals, Inc.
ANDA 074590Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mgDo.
ANDA 074619Glipizide Tablets USP, 5 mg and 10 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 074859Cimetidine HCl Oral Solution, 300 mg/5 mLANI Pharmaceuticals, Inc.
ANDA 074873Tretinoin Topical Solution USP, 0.05%Teva Pharmaceuticals USA.
ANDA 074899Etodolac Capsules USP, 200 mg and 300 mgANI Pharmaceuticals, Inc.
ANDA 074920Clonazepam Tablets USP, 0.5 mg, 1 mg, and 2 mgTeva Pharmaceuticals USA.
Start Printed Page 61429
ANDA 075020Hydroxyurea Capsule USP, 250 mg and 500 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 075055Captopril and Hydrochlorothiazide Tablets USP, 25/15 mg, 25/25 mg, 50/15 mg, and 50/25 mgIvax Pharmaceuticals, Inc.
ANDA 075110Cimetidine HCl Solution, 300 mg/5 mLANI Pharmaceuticals, Inc.
ANDA 075448Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 60 mg, and 120 mgIvax Pharmaceuticals, Inc.
ANDA 075482Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mgDo.
ANDA 075734Hydroxyurea Tablets USP, 1,000 mgBarr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 075763Nefazodone HCl Tablets USP, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mgIvax Pharmaceuticals, Inc.
ANDA 076136Ciprofloxacin Tablets USP, 250 mg, 500 mg, and 750 mgTeva Pharmaceuticals USA.
ANDA 076169Fexofenadine HCl Capsules, 60 mgBarr Laboratories, Inc., 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 076752Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcgMerck KGaA, c/o Icon Clinical Research, 212 Church Rd., North Wales, PA 19454.
ANDA 076988Prednisolone Sodium Phosphate Oral Solution USP, Prednisolone Base 15 mg/5 mLNesher Pharmaceuticals (USA) LLC, 13910 Saint Charles Rock Rd., Bridgeton, MO 63044.
ANDA 077176Metoprolol Succinate Extended-Release Tablets, 50 mgDo.
ANDA 077779Metoprolol Sucinate Extended-Release Tablets, 25 mgDo.
ANDA 080391Edetate Calcium Disodium InjectionWatson Laboratories, Inc., Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054.
ANDA 080505Carmol HC CreamFougera Pharmaceuticals Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747.
ANDA 080701Prednisone Tablets USP, 5 mgMutual Pharmaceutical Co., Inc.
ANDA 081054Hydroxyzine HCl Tablets, 100 mgPliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 083729Imipramine HCl Tablets USP, 10 mg, 25 mg, and 50 mgTeva Pharmaceuticals USA.
ANDA 083734Probenecid and Colchicine Tablets USP, 500 mg/0.5 mgIvax Pharmaceuticals, Inc.
ANDA 083740Probenecid Tablets USP, 500 mgDo.
ANDA 084106Hydralazine HCl Tablets USP, 25 mgMutual Pharmaceutical Co., Inc.
ANDA 084107Hydralazine HCl Tablets USP, 50 mgDo.
ANDA 084506Diphenhydramine HCl Capsules USP, 25 mgDo.
ANDA 084595Procainainde HCl Capsules USP, 375 mgIvax Pharmaceuticals, Inc.
ANDA 084606Procainamide HCl Capsules USP, 500 mgDo.
ANDA 084634Prednisone Tablets USP, 20 mgMutual Pharmaceutical Co., Inc.
ANDA 084978Micrainin (aspirin and meprobamate) Tablets, 325 mg/200 mgMeda Pharmaceuticals Inc.
ANDA 085627Amitriptyline HCl Tablets USP, 25 mgMutual Pharmaceutical Co., Inc.
ANDA 085742Amitriptyline HCl Tablets USP, 100 mgDo.
ANDA 085743Amitriptyline HCl Tablets USP, 75 mgDo.
ANDA 085744Amitriptyline HCl Tablets USP, 10 mgDo.
ANDA 085745Amitriptyline HCl Tablets USP, 50 mgDo.
ANDA 085836Amitriptyline HCl Tablets USP, 100 mgTeva Pharmaceuticals USA.
ANDA 086595Prednisone Tablets USP, 10 mgMutual Pharmaceutical Co., Inc.
ANDA 087265Spironolactone Tablets USP, 25 mgDo.
ANDA 087267Spironolactone and Hydrochlorothiazide Tablets USP, 25 mg/25 mgDo.
ANDA 087292Chlorthalidone Tablets USP, 25 mgDo.
ANDA 087293Chlorthalidone Tablets USP, 50 mgDo.
ANDA 087857Hydroxyzine HCl Tablets USP, 25 mgDo.
ANDA 087860Hydroxyzine HCl Tablets USP, 50 mgDo.
ANDA 087913Methyclothiazide Tablets USP, 2.5 mgIvax Pharmaceuticals, Inc.
ANDA 088409Hydroxyzine HCl Tablets USP, 10 mgMutual Pharmaceutical Co., Inc.
ANDA 088626Bromodiphenhydramine HCl and Codeine Phosphate Syrup, 12.5 mg/5 mL and 10 mg/5 mLWockhardt Bio AG, c/o Morton Grove Pharmaceuticals, Inc., 6451 Main St., Morton Grove, IL 60053.
ANDA 088728Hydralazine HCl Tablets USP, 10 mgMutual Pharmaceutical Co., Inc.
ANDA 088804Trimethobenzamide HCl Injection USP, 100 mg/mLHospira, Inc.
ANDA 088883Amitriptyline HCl Tablets USP, 10 mgPliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 088884Amitriptyline HCl Tablets USP, 25 mgPliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044.
ANDA 088885Amitriptyline HCl Tablets USP, 50 mgPliva, Inc., Subsidiary of Teva Pharmaceuticals USA.
ANDA 088886Amitriptyline HCl Tablets USP, 75 mgDo.
ANDA 088887Amitriptyline HCl Tablets USP, 100 mgDo.
ANDA 088888Amitriptyline HCl Tablets USP, 150 mgPliva Hrvatska d.o.o., Subsidiary of Teva Pharmaceuticals USA.
ANDA 088891Ergoloid Mesylates Tablets USP, 1 mgMutual Pharmaceutical Co., Inc.
Start Printed Page 61430
ANDA 089238Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mgMikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318.
ANDA 089244Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mgDo.
ANDA 089423Amitriptyline HCl Tablets USP, 150 mgMutual Pharmaceutical Co., Inc.
ANDA 090849Oxaliplatin for Injection USP, 50 mg/vial and 100 mg/vialSandoz Inc., 506 Carnegie Center, 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.

Start Signature

Dated: October 6, 2015.

Leslie Kux,

Associate Commissioner for Policy.

End Signature End Supplemental Information

[FR Doc. 2015-25922 Filed 10-9-15; 8:45 am]

BILLING CODE 4164-01-P