NDA 001104 | Doca (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 004589 | Alcohol in Dextrose Injection USP, 10 mL/100 mL and 5 grams (g)/100 mL | B. Braun Medical Inc., 901 Marcon Blvd., Allentown, PA 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 (HCl)) Solution 0.025 mg/5 mL and 2.5 mg/5 mL | G.D. Searle, LLC, 235 East 42nd St., New York, NY 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-Release Tablets, 120 mg | MSD Consumer Care, Inc., 556 Morris Ave., Summit, NJ 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 Injection USP, 5% | Do. |
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. |
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. |
Start Printed Page 61427 |
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., Philadelphia, 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 milliequivalents (mEq) and 20 mEq | Merck Sharp & Dohme Corp. |
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 Dextrose Injection | Do. |
NDA 019683 | Aminosyn II with Electrolytes in Dextrose with Calcium Injection | Do. |
NDA 019718 | Isolyte E (multi-electrolyte) Injection | B. Braun Medical Inc. |
NDA 019778 | Prinzide (lisinopril and hydrochlorothiazide) Tablets, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg | Merck Sharp & Dohme Corp. |
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 Dextrose | Baxter Healthcare Corp. |
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 Dextrose | Baxter Healthcare Corp. |
NDA 020177 | Travasol (amino acids) Injection With Electrolytes | Do. |
NDA 020811 | Acular PF (ketorolac tromethamine) Ophthalmic Solution, 0.5% | Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 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 mg, 2.5 mg/500 mg, and 5 mg/500 mg | Bristol-Myers Squibb, P.O. Box 4000 (Mailstop D12–02), Princeton, NJ 08543–4000. |
NDA 021788 | Synthetic 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 021961 | Simvastatin Orally Disintegrating Tablets, 10 mg, 20 mg, 40 mg, and 80 mg | Synthon Pharmaceuticals, Inc., 9000 Development Dr., 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 Syrup, 5 mg/5 mL and 1.5 mg/5 mL | Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals 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 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg | Watson Laboratories, Inc.—Florida, 2945 West Corporate 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 Pharmaceuticals USA, 19 Hughes, Irvine, CA 92618–1902. |
ANDA 061370 | Ampicillin Trihydrate for Oral Suspension, 125 mg/5 mL, 250 mg/5 mL | Teva Pharmaceuticals USA, 425 Privet Rd., Horsham, PA 19044. |
ANDA 061461 | Erythromycin Stearate Tablets USP, 250 mg and 500 mg | ANI Pharmaceuticals, Inc. |
ANDA 062338 | Eryc (erythromycin delayed-release capsules USP), 250 mg | Warner Chilcott (US) Inc., 100 Enterprise Dr., Rockaway, 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. |
Start Printed Page 61428 |
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 mg/5 mL | Sandoz Inc., 4700 Sandoz Dr., Wilson, NC 27893. |
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/80 mg | Pliva Inc., Subsidiary of Teva Pharmaceuticals USA, 425 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/50 mg | Teva Pharmaceuticals USA. |
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 Pharmaceuticals 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 mg | Do. |
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. |
Start Printed Page 61429 |
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, 25/25 mg, 50/15 mg, and 50/25 mg | Ivax Pharmaceuticals, Inc. |
ANDA 075110 | Cimetidine HCl Solution, 300 mg/5 mL | ANI Pharmaceuticals, Inc. |
ANDA 075448 | Isosorbide Mononitrate Extended-Release Tablets, 30 mg, 60 mg, and 120 mg | Ivax Pharmaceuticals, Inc. |
ANDA 075482 | Enalapril Maleate Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg | Do. |
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, 200 mg, and 250 mg | Ivax Pharmaceuticals, Inc. |
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 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg | Merck KGaA, c/o Icon Clinical Research, 212 Church Rd., North Wales, PA 19454. |
ANDA 076988 | Prednisolone Sodium Phosphate Oral Solution USP, Prednisolone Base 15 mg/5 mL | Nesher Pharmaceuticals (USA) LLC, 13910 Saint Charles 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 mg | Meda Pharmaceuticals Inc. |
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 mg/25 mg | Do. |
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 Syrup, 12.5 mg/5 mL and 10 mg/5 mL | Wockhardt Bio AG, c/o Morton Grove Pharmaceuticals, 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. |
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. |
Start Printed Page 61430 |
ANDA 089238 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/30 mg | Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318. |
ANDA 089244 | Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/60 mg | Do. |
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. |