|
New! As of May 1, 2004, New and Generic Drug Approvals 1998-2004,
will not be updated. |
| Product Name | Company | Application # |
Approval
Date |
Letter
|
Label
Posted |
Review
Posted |
|---|---|---|---|---|---|---|
| Nabumetone Tablets, 500 mg, Rx Second (Tentative Approval) | Copley Pharmaceutical, Inc. | ANDA 75-179 | 6/6/00 | 6/9/00 | 12/31/01 | |
| Nabumetone Tablets, 500 mg & 750 mg, Rx | Teva Pharmaceuticals USA | ANDA 75-189 S-01, S-02 | 9/24/01 | 4/9/03 | ||
| Nabumetone Tablets, 500 mg & 750 mg, Rx | Teva Pharmaceuticals USA | ANDA 75-189 | 5/26/00 | 6/6/00 | 12/28/01 | |
| Nabumetone Tablets, 500 mg and 750 mg, Rx, (Tentatively approved 12/24/98) | Teva Pharmaceuticals USA | ANDA 75-189 | 12/24/98 | 12/24/98 | ||
| Nabumetone Tablets, 500 mg and 750 mg, Rx | Eon Labs Manufacturing | ANDA 75-280 | 2/25/02 | 4/10/03 | ||
| Nabumetone Tablets, 500 mg and 750 mg, Rx, Tentatively approved August 6 | Eon Labs Manufacturing | ANDA 75-280 | 8/6/98 | 8/7/98 | ||
| Nabumetone Tablets, 500 mg and 750 mg, Rx | Invamed Inc. | ANDA 75-590 | 2/25/02 | |||
| Nabumetone Tablets, 500 mg and 750 mg, Rx, Tentatively approved 3/21/01 | Invamed Inc. | ANDA 75-590 | 3/21/01 | 3/30/01 | ||
| Nabumetone Tablets, 500 mg and 750 mg, Rx | IVAX Pharmaceuticals, Inc. | ANDA 76-009 | 1/24/03 | |||
| Nafcillin Injection, USP, in Galaxy Plastic Container, | Baxter Healthcare Corporation | NDA 50-665/S-012 | 8/23/02 | 8/30/02 | ||
| Nalbuphine Hydrochloride Injection, 10 mg/mL & 20 mg/mL. | King Pharmaceuticals, Inc. | ANDA 74-471 | 3/19/98 | 3/15/99 | ||
| Nallpen (nafcillin sodium) Injection, in Plastic Container, PL 2040, | Baxter Healthcare Corporation | NDA 50-655/S13 | 8/7/03 | 8/15/03 | ||
| Naltrexone Hydrochloride Tablets, 25, 50 & 100mg, Rx | Mallinckrodt, Inc. | ANDA 76-264 | 3/22/02 | 4/11/03 | ||
| Naltrexone Hydrochloride Tablets, 50 mg | Barr Laboratories | ANDA 74-918 | 5/8/98 | 5/8/98 | 3/19/99 | |
| Naltrexone Hydrochloride Tablets USP, 50 mg, Rx | Eon Labs Manufacturing, Inc. | ANDA 75-434 | 3/8/00 | 3/9/00 | 12/6/01 | |
| Naltrexone Hydrochloride Tablets, 50 mg | Amide Pharmaceutical, Inc. | ANDA 75-274 | 5/26/99 | 6/1/99 | 7/11/01 | |
| Namenda (Memantine Hydrochloride) Tablets, | Forest Laboratories | NDA 21-487 | 10/16/03 | 10/22/03 | 10/20/03 | 12/30/03 |
| Naprosyn (naproxen), Suspension and Anaprox (naproxen sodium), Rx | Syntex Development Research | NDA 17-581/S-098, 18-965/S-007 & 18-164/S-049 | 4/14/03 | |||
| Naproxen Delayed-release Tablets, 375 mg & 500 mg. | Purepac Pharmaceutical Co. | ANDA 74-936 | 2/24/98 | 3/19/99 | ||
| Naproxen Tablets, 250 mg, 375 mg and 500 mg, Rx | Interpharm, Inc. | ANDA 75-927 | 12/18/01 | |||
| Naproxen Delayed-release Tablets, 375 mg and 500 mg, Rx | Alphapharm Pty. Ltd. | ANDA 75-390 | 4/19/01 | 4/24/01 | 12/17/01 | |
| Naproxen Delayed-release Tablets, 375 mg and 500 mg, Rx | Alphapharm Pty. Ltd. | ANDA 75-390 | 4/19/01 | 4/24/01 | 12/17/01 | |
| Naproxen Delayed-release Tablets, 375 mg and 500 mg, Rx | Sidmak Laboratories, Inc. | ANDA 75-337 | 5/26/99 | 6/1/99 | ||
| Naproxen Delayed-release Tablets, 375 mg and 500 mg, Rx | Teva Pharmaceuticals | ANDA 75-227 | 6/30/98 | 6/30/98 | ||
| Naproxen Delayed-release Tablets, 375 mg & 500 mg. | Invamed, Inc. | ANDA 75-061 | 2/18/98 | 3/19/99 | ||
| Naproxen Sodium Extended-release Tablets, 375 & 500 mg, Rx | Andrx Pharmaceuticals, Inc. | ANDA 75-416/S2, S3 | 4/23/03 | |||
| Naproxen Sodium Extended-release Tablets, 500 mg, Rx | Andrx Pharmaceuticals, Inc. | ANDA 75-416 | 8/27/02 | |||
| Naproxen Sodium Extended-release Tablets, 375 mg and 500 mg, Rx, Tentatively Approved 7/5/2001 | Andrx Pharmaceuticals, Inc. | ANDA 75-416 | 7/5/01 | |||
| Naproxen Sodium Extended-release Tablets, 500 mg (base), Rx Tentatively Approved 3/17/00 | Andrx Pharmaceuticals, Inc. | ANDA 75-416 | 3/17/00 | 3/21/00 | ||
| Naproxen Sodium Tablets, 275 & 550 mg, Rx | Able Laboratories | ANDA 76-544 | 8/22/03 | |||
| Naproxen Sodium Pseudoephedrine Extended-Release Tablets, 200 mg (120 mg base), OTC | L. Perrigo Co. |
ANDA 76-518 | 3/17/04 | 3/17/04 | ||
| Naproxen Tablets, Rx | West-Ward Pharmaceutical |
ANDA 76-494 | 1/14/04 | |||
| Narcan (naloxone hydrochloride) Injection USP, | Endo Pharmaceuticals, Inc. | NDA 16-636/S-052, S-054 | 2/11/02 | 3/8/02 | ||
| Nardil (phenelzine sulfate) Tablets, 15 mg | Pfizer Inc. | NDA 11-909/S-033 | 9/2/03 | 09/09/03 | 09/09/03 | |
| Naropin (ropivacaine HCI) Injection,Rx | AstraZeneca L.P. | NDA 20-533/S-002 | 11/2/00 | |||
| Naropin Indication:for the production of local or regional anesthesia for surgery and for acute pain management. | ||||||
| Nasacort AQ (triamcinolone acetonide) Nasal Aerosol, | Aventis Pharmaceuticals | NDA 20-784 | 4/7/04 | |||
| Nasacort AQ (triamcinolone acetonide) Nasal Spray, | Aventis Pharmaceuticals | NDA 20-468/S13 | 3/8/04 | 3/10/04 | 4/7/04 | |
| Nasacort AQ (triamcinolone acetonide) Nasal Spray, | Aventis Pharmaceuticals | NDA 20-468/S-012 | 12/23/03 | 1/9/04 | 1/15/04 | |
| Nasacort AQ (triamcinolone acetonide) Nasal Spray, | Aventis Pharmaceuticals | NDA 20-468/S-011 | 12/17/03 | 12/22/03 | 12/29/03 | |
| NasalCrom Nasal Solution (cromolyn sodium nasal solution) Nasal Spray. | Pharmacia Consumer Healthcare | NDA 20-463/S-002 | 3/27/01 | 4/27/01 | 8/21/01 | |
| Nasalide (Flunisolide) Nasal Spray, | Ivax Research, Inc. | NDA 18-148/S30, S35 & 20-409/S-005, S11 | 5/9/02 | 5/16/02 | ||
| Nasalide (Flunisolide) Nasal Spray, 25 mcg | Dura Pharmaceuticals | NDA 18-148/S023 | 2/25/99 | 6/22/01 | ||
| Nasarel (flunisolide) Nasal Spray, 25 mcg. | Dura Pharmaceuticals | NDA 20-409/S-006 | 3/27/01 | 4/27/01 | ||
| Nascobal (cyanocobalamin, USP) Gel for Intranasal Administration, | Questcor Pharmaceuticals | NDA 19-722/S-006 | 8/21/03 | 8/28/03 | 8/28/03 | |
| Nascobal (cyanocobalamin, USP) Gel for Intranasal Administration, | Nastech Pharmaceutical Co. | NDA 19-722/S-004 | 6/14/02 | 6/17/02 | ||
| Nasonex (Mometasone Furoate Monohydrate) Aqueous Nasal Spray, Rx | Schering Corp. | NDA 20-762/S21 | 12/18/03 | 12/23/03 | 12/29/03 | |
| Nasonex (Mometasone Furoate Monohydrate) Aqueous Nasal Spray, Rx | Schering Corp. | NDA 20-762/S-014 | 3/3/03 | 3/10/03 | ||
| Nasonex Nasal Spray, 50 mcg., Rx | Schering Corp. | NDA 20-762/S-001 | 11/19/98 | 1/12/99 | 5/25/01 | |
| Nasonex Indication: Prophylaxis and treatment of the nasal symptoms of seasonal allergic rhinitis and the treatment of the nasal symptoms of perennial allergic rhinitis, in adults and children 12 years of age and older. | ||||||
| Natrecor (nesiritide) for injection, 1.5 mg/vial | Scios, Inc. | NDA 20-920 | 8/10/01 | 8/14/01 | 8/14/01 | 10/17/01 |
| Navane (thiothixene HCI) Capsules and Oral Concentrate, Rx | Pfizer, Inc. | NDA 16-584/S56
16-758/S17
|
5/19/03 | 6/16/03 | ||
| Navane (thiothixene HCI) Capsules and Oral Concentrate, Rx | Pfizer, Inc. | NDA
16-584/S-055/S-047 NDA 16-758/S-016/S-011
|
7/31/01 | 11/21/02 | ||
| Navelbine (vinorelbine tartrate) Injection. | SmithKlineBeecham | 20-388/S-010 | 10/2/01 | 7/24/03 | 4/23/03 | |
| Navelbine (vinorelbine tartrate) Injection. | SmithKlineBeecham | 20-388/S-014 | 11/5/02 | 11/18/02 | 11/8/02 | |
| Navelbine (Vinorelbine) Injection, | Glaxo Wellcome Inc. | NDA 20-388/S8 | 6/8/00 | 6/19/02 | 6/19/02 | 6/19/02 |
| Nebcin (tobramycin sulfate injection, USP)-Vials and Hyporets, Rx | Eli Lilly and Company | NDA 50-477/S-024 & 50-519/S-024 | 4/2/03 | 4/18/03 | ||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Ranbaxy | ANDA 76-409 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Ranbaxy | ANDA 76-409 | 4/17/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Dr. Reddy's Laboratories | ANDA 76-309 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Dr. Reddy's Laboratories | ANDA 76-309 | 7/7/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Eon Labs, Inc. | ANDA 76-302 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Eon Labs, Inc. | ANDA 76-302 | 10/28/02 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Roxane Laboratories, Inc. | ANDA 76-196 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Roxane Laboratories, Inc. | ANDA 76-196 | 1/14/03 | |||
| Nefazodone Hydrochloride Tablets, 100, 150, 200 & 250 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 76-129 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Mylan Pharmaceuticals, Inc. | ANDA 76-129 | 10/29/02 | |||
| Nefazodone Hydrochloride Tablets, 150, 200 & 250 mg, Rx | Watson Laboratories, Inc. | ANDA 76-073 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Watson Laboratories, Inc. | ANDA 76-073 | 10/29/02 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Geneva Pharmaceuticals, Inc. | ANDA 76-072 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Geneva Pharmaceuticals, Inc. | ANDA 76-072 | 1/30/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Teva Pharmaceuticals | ANDA 76-037 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx | Ivax Pharmaceuticals | ANDA 75-763 | 9/16/03 | |||
| Nefazodone Hydrochloride Tablets, 50, 100, 150, 200 & 250 mg, Rx, Tentatively Approved | Ivax Pharmaceuticals | ANDA 75-763 | 6/11/03 | |||
| Neomycin Sulfate Oral Solution USP, 125 mg/5 mL, Rx | Pharma-Tek, Inc. | ANDA 65-010 | 2/6/04 | |||
| Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment USP, Rx | Akorn, Inc. | ANDA 65-088 | 5/23/02 | 4/9/03 | ||
| Neoral (cyclosporine) Soft Gelatin Capsules USP, MODIFIED, 25 mg, 100 mg, | Novartis Pharmaceuticals Corporation | NDA 50-715/S19, S20 & 50-716/S20, S21 | 2/6/04 | 2/27/04 | 4/5/04 | |
| Neoral (cyclosporine) Soft Gelatin Capsules USP, MODIFIED, 25 mg, 100 mg, | Novartis Pharmaceuticals Corporation | NDA 50-715/S-010, S-014 & 50-716/S-014, S-018 | 6/12/02 | 6/17/02 | 6/13/02 | |
| NeoTect (Kit for the Preparation of Technetium Tc 99m Depreotide) | Diatide Inc. | NDA 21-012 | 8/3/99 | 7/3/00 | 8/6/99 | 7/3/00 |
| NephrAmine (essential amino acid injection), | B. Braun Medical Inc. | NDA 17-766/S-028 | 6/12/02 | 6/17/02 | ||
| Neurontin (gabapentin) tablets, capsules and oral solution, Rx | Parke-Davis Pharmaceutical Research | NDA 21-397, 21-423 & 21-424 | 5/24/02 | 6/3/02 | 5/28/02 | |
| Neurontin (gabapentin) Capsules, Rx | Parke-Davis | NDA 20-235 /S11 |
9/29/98 | 1/8/99 | 1/8/99 | 7/14/99 |
| Neurontin Indication: As adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy. | ||||||
| Neurontin (gabapentin) Capsules, Tablets, and Oral Solution, | Parke-Davis Pharmaceuticals Ltd. | NDA 20-235/S-023, 20-882/S-009, 21-129/S-010 | 8/15/02 | 8/21/02 | ||
| Neurontin (gabapentin) Capsules, Tablets, and Oral Solution, | Pfizer Inc. | NDA 20-235/S-022, 20-882/S-008, 21-129/S-009 & 21-216/S-001 | 1/30/02 | 3/6/02 | ||
| Neurontin (gabapentin) oral solution, capsule & tablet, Rx | Parke-Davis Pharmaceutical Research | NDA 21-216, 20-235/S015, 20-882/S002 | 10/11/00 | 11/16/00 | 11/16/00 | |
Neurontin Indication: Adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. |
||||||
| Neurontin (gabapentin) oral solution,Rx | Parke-Davis Pharmaceutical Research | NDA 21-129 | 3/2/00 | |||
Neurontin Indication: Adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy (This NDA provided bioequivalency data to support an oral liquid dosage form of gabapentin for the same indications as the already approved Neurontin capsule.) |
||||||
| Neurontin (gabapentin) Tablets, 600 and 800 mg, Rx | Parke-Davis | NDA 20-882 | 10/9/98 | 10/13/98 | 12/14/98 | |
| Neurontin Indication:Anticonvulsant | ||||||
| Neutrexin (trimetrexate glucuronate) Injection, 25 mg, 200 mg, | MedImmune Oncology, Inc. | NDA 20-326/S-011, S-013 | 6/26/02 | 7/2/02 | 6/27/02 | |
| Nexium (esomeprazole magnesium) Delayed-Release Capsules, Rx | AstraZeneca L.P. | NDA 21-153/S15 | 4/23/04 | |||
| Nexium (esomeprazole magnesium) Delayed-Release Capsules, Rx | AstraZeneca L.P. | NDA 21-153/S8 | 1/9/04 | 1/14/04 | 1/15/04 | |
| Nexium (esomeprazole magnesium) Delayed-Release Capsules, Rx | AstraZeneca L.P. | NDA 21-153/S-5 | 9/19/02 | 9/24/02 | 10/15/03 | |
| Nexium (esomeprazole magnesium) Delayed-Release Capsules, Rx | AstraZeneca L.P. | NDA 21-153/S-4 | 2/27/03 | 3/10/03 | ||
| Nexium (esomeprazole magnesium) Delayed-Release Capsules, Rx | AstraZeneca L.P. | NDA 21-153 & 21-154 | 2/20/01 | 4/23/03 | 9/7/01 | |
|
Nexium Indications:
N21-153: 1) healing of erosive esophagits; 2) maintenance of healing
of erosive esophagitis; and 3) treatment of symptomatic
gastroesophageal reflux disease. N21-154: Nexium in combination with clarithromycin and amoxicillin for the eradication of Helicobacter pylori in patients with duodenal ulcer disease or a history of duodenal ulcer disease. |
||||||
| Niacin Extended-Release Tablets, 500 & 750mg, Rx Tentative Approval | Barr Laboratories, Inc. | ANDA 76-378 | 6/13/03 | |||
| Niacin Extended-Release Tablets, 1000mg, Rx Tentative Approval | Barr Laboratories, Inc. | ANDA 76-250 | 5/9/03 | |||
| Niacor (Niacin) Tablets USP, 500 mg, Rx | Upsher-Smith Laboratories, Inc. | ANDA 40-378 | 5/3/00 | 5/22/00 | 8/4/03 | |
| Niaspan (niacin extended-release) Tablets, 500 mg, 750 mg, 1000 mg, Rx | Kos Pharmaceuticals | NDA 20-381/S-13 | 1/31/03 | 2/12/03 | 2/13/03 | |
| Niaspan (niacin extended-release tablets), Rx | Kos Pharmaceuticals | NDA 20-381/S-007 | 9/13/99 | 9/24/99 | ||
| Niaspan (niacin extended-release tablets), Rx | Kos Pharmaceuticals | NDA 20-381/S-006 | 10/28/99 | 12/29/99 | ||
| Nicardipine Hydrochloride Capsules, 20 mg & 20 mg. | Genpharm, Inc. | ANDA 74-928 | 3/19/98 | 3/19/99 | ||
| NicoDerm CQ (nicotine transdermal system) clear and opaque, 21mg, 14mg, and 7 mg | GlaxoSmithKline Consumer Healthcare | NDA 20-165/S-020 | 8/13/02 | 8/14/02 | ||
| Nicorette Gum, 4 mg | GlaxoSmithKline | NDA 20-066/S16 | 4/23/04 | |||
| Nicorette Gum, 4 mg | SmithKline Beecham Consumer Healthcare | NDA 20-066/S10 | 9/25/00 | 5/1/02 | 5/1/02 | 5/1/02 |
| Nicorette (Nicotine Polacrilex) Gum, 2 mg | GlaxoSmithKline | NDA 18-612/S34 | 4/23/04 | |||
| Nicorette (Nicotine Polacrilex) Gum, 2 & 4 mg | SmithKline Beecham Consumer Healthcare | NDA 18-612/S031 & 20-066/S13 | 8/9/02 | 8/12/02 | ||
| Nicorette 2 & 4 mg (Nicotine Polacrilex) Gum, | SmithKline Beecham Consumer Healthcare | NDA 18-612/S025 & 20-066/S7 | 12/23/1998 | 5/1/02 | 5/1/02 | 5/1/02 |
| Nicotine Polacrilex Gum USP, 2 mg (base) | Circa Pharmaceuticals, Inc. | NDA 74-507 | 3/15/99 | 3/16/99 | 4/23/03 | |
| Nicotine Polacrilex Gum USP, 4 mg (base). | Circa Pharmaceuticals, Inc. | NDA 74-707 | 3/19/99 | 3/22/99 | 4/22/03 | |
| Nicotrol Inhaler (nicotine inhalation system), | Pharmacia Consumer HealthCare | NDA 20-714/S-010 | 9/8/02 | 9/11/02 | ||
| Nicotrol Patch (nicotine transdermal system), 15 mg | Pharmacia and Upjohn Company | NDA 20-536/S-010 | 7/23/02 | 7/24/02 | ||
| Nicotrol NS & Inhaler, | Pharmacia Consumer Healthcare | NDA 20-385/S5 & 20-714/S11 | 11/6/03 | 11/25/03 | ||
| Nicotrol NS (nicotine nasal spray), | Pharmacia Consumer Healthcare | NDA 20-385/S-005 | 9/8/02 | 9/11/02 | ||
| Nicotrol TD (nicotine transdermal system), | Pharmacia Consumer Healthcare | NDA 20-150/S-011 | 3/21/02 | 3/29/02 | ||
| Nifedipine Extended-release Tablets, 90 mg. , Rx | Biovial Laboratories Inc. | ANDA 76-070 | 8/16/02 | |||
| Nifedipine Extended-release Tablets, 60 mg. ,Rx (Tentatively approved 3/20/01) | Elan Pharmaceutical Research Corp. | ANDA 75-659 | 3/20/01 | 3/30/01 | ||
| Nifedipine Extended-release Tablets, 90 mg. ,Rx | Martec Scientific | ANDA 75-414 | 3/23/04 | |||
| Nifedipine Extended-release Tablets, 30 mg. ,Rx | Biovail Laboratories Inc. | ANDA 75-289/S1 | 2/6/01 | 3/6/01 | ||
| Nifedipine Extended-release Tablets, 60 mg. ,Rx, 30mg strength remains Tentatively Approved | Biovail Laboratories Inc. | ANDA 75-289 | 9/28/00 | 10/30/00 | ||
| Nifedipine Extended-release Tablets, 30 mg & 60 mg. ,Rx (Tentatively approved 7/24/00) | Biovail Laboratories Inc. | ANDA 75-289 | 7/24/00 | 10/30/00 | ||
| Nifedipine Extended-release Tablets, 30 mg & 60 mg., Rx | Biovail Laboratories Inc. | ANDA 75-269 | 12/4/00 | 2/28/01 | ||
| Nifedipine Extended-release Tablets, 30 mg & 60 mg. (Tentatively approved 6/29/99) | Biovail Laboratories Inc. | ANDA 75-269 | 6/29/99 | 6/30/99 | ||
| Nifedipine Extended-release Tablets, 30 mg., Rx | Elan Pharmaceutical | ANDA 75-128 | 3/10/00 | 3/15/00 | ||
| Nifedipine Extended-release Tablets, 30 mg. (Tentatively Approved 5/28/99) | Elan Pharmaceutical | ANDA 75-128 | 5/28/99 | 6/1/99 | ||
| Nifedipine Extended-release Tablets, 30 mg (Tentatively approved 3/15/99) | Mylan Pharmaceuticals, Inc. | ANDA 75-108 | 3/15/99 | 3/16/99 | ||
| Nifedipine Extended-release Tablets, 30 mg | Mylan Pharmaceuticals, Inc. | ANDA 75-108 | 12/17/99 | 12/27/99 | 8/23/01 | |
| Nimbex (cisatracurium besylate) injection, | Abbott Laboratories | NDA 20-551/S-010 | 6/4/02 | 6/14/02 | ||
| Nimbex (cisatracurium besylate) injection, | Abbott Laboratories | NDA 20-551/S-009 | 7/18/03 | 7/28/03 | ||
| NIMOTOP (nimodipine) Capsules,30 mg, Rx | Bayer Corporation Pharmaceutical Division | NDA 18-869/S10 | 8/22/00 | 8/23/00 | 8/23/00 | |
| NIMOTOP (nimodipine) Capsules,Rx | Bayer Corporation Pharmaceutical Division | NDA 18-869 | 8/22/00 | |||
| Nimotop Indications: for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranialberry aneurysms regardless of their post-ictus neurologic condition. | ||||||
| Nitro-Dur (nitroglycerin) Transdermal Infusion System, 0.1 mg/hr, 0.2 mg/ hr, 0.3 mg/hr, 0.4 mg/hr, 0.6 mg/hr and 0.8 mg/ hr., | Schering Corporation | NDA 20-145 / S-016 | 10/18/02 | 10/28/02 | ||
| Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, 100mg, Rx | Mylan Pharmaceuticals | ANDA 76-648 | 3/22/04 | 3/23/04 | ||
| Nitroglycerin Transdermal System, 0.6 mg/hr. | Mylan Technologies, Inc. | ANDA 74-992 | 11/12/99 | 7/11/01 | ||
| Nitroglycerin Transdermal System, 0.1 mg/hr. | Mylan Pharmaceuticals, Inc. | ANDA 75-033 | 2/6/98 | 3/19/99 | ||
| Nitroglycerin Transdermal Systems, Rx | Mylan Technologies, Inc. | ANDA 75-073, 75-075, & 75-076 | 11/12/99 | 7/11/01 | ||
| Nitroglycerin Transdermal Systems, 0.2 mg/hr, Rx | Hercon Laboratories Corporation | ANDA 89-884 | 10/30/98 | 11/2/98 | 8/4/03 | |
| Nitroglycerin Transdermal Systems, 0.4 mg/hr, Rx | Hercon Laboratories Corporation | ANDA 89-885 | 10/30/98 | 11/2/98 | 8/4/03 | |
| Nitroglycerin Transdermal Systems, 0.6 mg/hr, Rx | Hercon Laboratories Corporation | ANDA 89-886 | 10/30/98 | 11/2/98 | 8/4/03 | |
| Nitrolingual Pumpspray (nitroglycerin lingual spray), 400 mcg per spray. | G. Pohl Boskamp GmbH & Co. | NDA 18-705/S-012 | 11/5/02 | 11/19/02 | ||
| Nitrostat (nitroglycerin sublingual Tablets, 0.3, 0.4, & 0.6 mg, Rx | Parke-Davis | NDA 21-134 | 5/1/00 | 5/1/00 | 5/1/00 | 6/7/01 |
| Nix Creme Rinse (1% permethrin shampoo) | Pfizer Incorporated | NDA 19-918/S-009 | 1/17/02 | 2/5/02 | ||
| Nizatidine Capsules USP, 150 & 300 mg, Rx | Torpharm | ANDA 76-383 | 1/23/03 | |||
| Nizatidine Capsules USP, 150 & 300 mg, Rx | Eon Labs Manufacturing, Inc. | ANDA 76-178 | 7/5/02 | |||
| Nizatidine Capsules USP, 150 & 300 mg, Rx Tentatively Approved | Eon Labs Manufacturing, Inc. | ANDA 76-178 | 3/12/02 | 4/11/03 | ||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx | Genpharm Inc. | ANDA 75-934 | 7/9/02 | |||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx Tentatively Approved | Genpharm Inc. | ANDA 75-934 | 9/28/01 | 4/16/03 | ||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx | Mylan Pharmaceuticals, Inc. | ANDA 75-806 | 7/5/02 | |||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx Tentatively Approved | Mylan Pharmaceuticals, Inc. | ANDA 75-806 | 11/15/00 | 11/17/00 | ||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx | TEVA Pharmaceuticals | ANDA 75-668 | 9/12/02 | |||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx | Watson Laboratories, Inc. | ANDA 75-616 | 7/9/02 | |||
| Nizatidine Capsules USP, 150 mg & 300 mg, Rx Tentatively Approved | Danbury Pharmacal, Inc. | ANDA 75-616 | 10/25/00 | 11/7/00 | ||
| Nizatidine Capsules USP, 150 mg & 300 mg | Zenith Goldline Pharmaceuticals, Inc. | ANDA 75-461 | 7/8/02 | |||
| Nizatidine Capsules USP, 150 mg & 300 mg Tentatively Approved | Zenith Goldline Pharmaceuticals, Inc. | ANDA 75-461 | 8/26/99 | 9/2/99 | ||
| Nolvadex (tamoxifen citrate) Tablets, 20 mg, Rx. | Astra Zeneca Pharmaceuticals | NDA 21-109 17-970/S50 | 8/30/02 | 9/12/02 | 8/30/02 | 2/20/03 |
| Nolvadex (tamoxifen citrate) Tablets, Rx. | AstraZeneca Pharmaceuticals | NDA 17-970/S49 FA, S51 | 1/30/03 | 2/12/03 | 7/5/03 | |
| Nolvadex (tamoxifen citrate) Tablets, Rx. | Astra Zeneca Pharmaceuticals | NDA 17-970/S37, S44 & S49 | 5/16/02 | 5/21/02 | 5/16/02 | |
| Nolvadex (tamoxifen citrate) Tablets, Rx. | Astra Zeneca Pharmaceuticals | NDA 17-970/S048 | 6/10/03 | 7/8/03 | 7/8/03 | |
| Nolvadex (tamoxifen citrate) Tablets, Rx. | Astra Zeneca Pharmaceuticals | NDA 17-970/S046 | 6/29/00 | 7/14/00 | 7/6/00 | 12/18/01 |
| Nolvadex Indication: - In women with DCIS, following breast surgery and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer. | ||||||
| Nolvadex (tamoxifen citrate) Tablets, Rx. Tamoxifen Information Page | Zeneca Pharmaceuticals | NDA 17-970/SE1-040 | 10/29/98 | 10/29/98 | 10/29/98 | 11/10/98 |
| Nolvadex Indication- Reduce the incidence of breast cancer in women at high risk for breast cancer. | ||||||
| Nolvadex (tamoxifen citrate) Tablets, Rx | Zeneca Pharmaceuticals | NDA 17-970/SE1-039 | 10/29/98 | 10/29/98 | 10/29/98 | 6/28/99 |
| Nolvadex Indication- reduce the occurrence of contralateral breast cancer in patients receiving adjuvant Nolvadex therapy for breast cancer. | ||||||
| Norcuron (vecuronium bromide) Injection, | Organon, Inc. | NDA 18-776/S-027 | 5/19/03 | |||
| Norditropin (somatropin [rDNA origin] injection) Cartridges,5mg/1.5mL, 10mg/1.5mL, & 15mg/1.5mL, Rx | Novo Nordisk Pharmaceuticals, Inc. | NDA 21-148 | 6/20/00 | 7/24/00 | 7/24/00 | |
| Norditropin Indications: long-term treatment of children who have growth failure due to inadequate secretion of endogenous growth hormone. | ||||||
| Norditropin (somatropin [rDNA origin] injection) Cartridges,5mg/1.5mL, 10mg/1.5mL, & 15mg/1.5mL, Rx | Novo Nordisk Pharmaceuticals, Inc. | NDA 21-148/S1 | 4/10/01 | 4/9/03 | ||
| Norepinephrine Bitartrate Injection USP, 1 mg (base)/mL, Rx | Bedford Laboratories | ANDA 40-462 | 10/31/03 | |||
| Norepinephrine Bitartrate Injection USP, 1 mg (base)/mL, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 40-455 | 3/3/03 | |||
| Norethindrone Acetate Tablets USP, 5 mg, Rx | Barr Laboratories, Inc. | ANDA 75-951 | 5/25/01 | 6/5/01 | 12/24/03 | |
| Norfloxacin Tablets USP, 400 mg, Rx Tentatively Approved 4/26/00 | Novopharm Limited | ANDA 74-690 | 4/26/00 | 4/28/00 | ||
| Norgesic/Norgesic Forte Tablets, Rx | Riker Laboratories, Inc. | NDA 13-416/S21 | 11/25/02 | 12/6/02 | 11/26/02 | |
| Norgestimate
and Ethinyl Estradiol Tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg,
and 0.25 mg/0.035 mg, packaged in 28-day cycle regimens, Rx Tentatively Approved 1/6/2004 |
Andrx Pharmaceuticals | ANDA 76-335 | 1/6/04 | |||
| Norgestrel and Ethinyl Estradiol | SCS Pharmaceuticals | ANDA 075288 | 07/28/1999 | 12/23/03 | ||
| Noritate (metronidazole cream) Cream, 1%, Rx | Dermik Laboratories | NDA 20-743/S002 | 4/4/03 | 4/18/03 | 4/18/03 | |
| Noroxin (norfloxacin) Tablets, 400 mg, Rx | Merck & Co., Inc. | NDA 19-384/S-037, S-038, S-039 | 4/23/01 | 4/7/03 | ||
| NORPLANT SYSTEM
(levonorgestrel implant), Rx |
Wyeth Pharmaceuticals | NDA 20-088/S18 | 1/6/04 | 1/9/04 | ||
| NORPLANT SYSTEM (levonorgestrel implant) | Wyeth Ayerst Laboratories, Inc. | NDA 20-088/S-016 | 1/15/02 | 2/7/02 | ||
| Nortrel 7/7/7 (Norethindrone and Ethinyl Estradiol) Tablets USP, 0.5mg/0.035 mg, 0.75 mg/0.035 mg, and 1 mg/0.0.35 mg, Rx | Barr Laboratories, Inc. | |||||