This listing is sorted by product name. When the drug approval or tentative approval letter, labeling text or review are available, a hyperlink posting date will take you to the source document.
|
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 |
|---|---|---|---|---|---|---|
| 8-MOP (methoxsalen) Capsules, USP, 10 mg, Rx | ICN Pharmaceuticals, Inc. | NDA 9-048/S-037 | 3/26/03 | 4/15/03 | 4/1/03 | |
| (17-beta-estradiol transdermal), patch 3 sizes 13.5, 20, and 27cm2, with normal delivery of .05, .075 and 0.1mg per day for 7 days., Rx Trade name not established | Wyeth-Ayerst | NDA 21-048 | 9/20/99 | 9/24/99 | 9/24/99 | |
| 17-beta-estradiol transdermal Indication: Treatment of vulvar vaginal atrophy and vasomotor symptoms | ||||||
| Abilify (aripiprazole) Tablets, Rx | Otsuka | NDA 21-436/S6 | 4/8/04 | |||
| Abilify (aripiprazole) Tablets, Rx | Otsuka Pharmaceutical Co., Ltd. | NDA 21-436/S1 | 8/28/03 | 09/09/03 | 09/09/03 | |
| Abilify (aripiprazole) Tablets, 2, 5, 10, 15, 20 and 30 mg, Rx | Otsuka Pharmaceutical Co., Ltd. | NDA 21-436 | 11/15/02 | 11/22/02 | 11/18/02 | 3/7/03 |
Abreva Cream , Topical, OTC |
Avanir Pharmaceutical | NDA 20 941 | 7/25/00 | 12/6/00 | 12/6/00 | 8/21/01 |
| Abreva Indication: cold sore/fever blister treatment | ||||||
| Accolate (Zafirlukast) Tablets, | AstraZeneca LP | NDA 20-547/S19 | 3/26/04 | 4/7/04 | ||
| Accolate (Zafirlukast) Tablets, | AstraZeneca LP | NDA 20-547/S17 | 3/26/04 | 4/7/04 | ||
| Accolate (Zafirlukast) Tablets, | AstraZeneca LP | NDA 20-547/S17 | 10/31/03 | 11/25/03 | ||
| Accolate Tablets, 10 mg & 20 mg | AstraZeneca LP | NDA 20-547/S-014 | 4/27/01 | 7/29/03 | ||
| Accolate (Zafirlukast) Tablets, 10 mg & 20 mg | Zeneca Pharmaceuticals | NDA 20-547/S-011 | 2/7/00 | 6/8/01 | ||
| Accolate Tablets, 20 mg | Zeneca Pharmaceuticals | NDA 20-547/S-008 | 3/17/99 | 6/22/01 | ||
| Accolate Tablets, 10 mg | Zeneca Pharmaceuticals | NDA 20-547/S-007 | 9/17/99 | 9/24/99 | 4/14/04 | |
| Accolate Indication: For the use of Accolate 10 mg oral Tablets for the prophylaxis and chronic treatment of asthma in pediatric patients 7 - 11 years of age. | ||||||
| AccuNeb Inhalation Solution,Rx | Dey L.P. | NDA 20-949 | 4/30/01 | 7/23/03 | ||
| AccuNeb Indications: relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease). | ||||||
| Accupril and Accuretic (quinapril hydrochloride & hydrochlorothiazide) Tablets, | Pfizer Inc. | NDA 19-885/S23 & 20-125/S3 | 10/29/03 | 11/5/03 | ||
| Accupril (quinapril hydrochloride) Tablets, | Pfizer Inc. | NDA 19-885/S-019 | 7/22/02 | 7/24/02 | ||
| Accupril (quinapril hydrochloride) Tablets. | Pfizer Inc. | NDA 19-885/S-018 | 4/17/01 | 5/3/01 | 12/24/03 | |
| Accuretic Tablets, Rx | Parke-Davis | NDA 20-125 | 12/28/99 | 1/3/00 | 1/3/00 | 5/31/01 |
| Accuretic Indication:Treatment of hypertension | ||||||
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S48 & S52 | 8/27/03 | 8/29/03 | 8/29/03 | |
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-051 | 6/20/02 | 6/24/02 | 6/21/02 | |
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. (Patient Information) | Hoffmann-La Roche Inc. | NDA 18-662/S-047 | 4/12/02 | 4/16/02 | ||
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-046 | 2/15/02 | 2/21/02 | 2/21/02 | |
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-044 | 10/30/01 | 11/2/01 | 11/2/01 | |
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-043 | 5/2/02 | 5/16/02 | 5/3/02 | |
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-041/045 | 12/31/01 | 1/23/02 | 1/23/02 | |
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-040 | 5/1/00 | 1/17/01 | ||
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-039 | 5/1/00 | 1/17/01 | ||
| Accutane (isotretinoin) Capsules, 10 mg, 20 mg, and 40 mg. | Hoffmann-La Roche Inc. | NDA 18-662/S-038 | 5/1/00 | 1/17/01 | ||
| Acebutolol Hydrochloride Capsules,200 mg (base) and 400 mg (base). | Par Pharmaceutical, Inc. | ANDA 75-047 | 12/30/99 | 1/3/00 | ||
| Aceon (perindopril erbumine) Tablets, | Solvay Pharmaceuticals | NDA 20-184/S-009 | 10/29/03 | 11/25/03 | ||
| Acetadote (acetylcysteine) Injection, | Cumberland Pharmaceuticals, Inc. | NDA 21-539/S2 | 4/28/04 | |||
| Acetadote (acetylcysteine) Injection, | Cumberland Pharmaceuticals, Inc. | NDA 21-539/S1 | 4/28/04 | |||
| Acetadote (acetylcysteine) Injection, | Cumberland Pharmaceuticals, Inc. | NDA 21-539 | 1/23/04 | 2/2/04 | 2/2/04 | |
| Acetaminophen Extended-release Tablets, 650 mg, OTC | Coerpharma LLC | ANDA 76-200 | 3/19/02 | 5/23/02 | ||
| Acetaminophen Extended-release Tablets, 650 mg, OTC | L. Perrigo Company | ANDA 75-077 | 2/25/00 | 2/29/00 | 6/7/01 | |
| Acetaminophen, Aspirin & Caffeine Tablets, 250 mg/250 mg/65 mg, OTC | L. Perrigo Company | ANDA 75-794 | 11/26/01 | 4/15/03 | ||
| Acetaminophen, Aspirin & Caffeine Tablets, 250 mg/250 mg/65 mg, OTC | L. Perrigo Company | ANDA 75-794 | 7/12/01 | |||
| Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablets,712.8 mg, 60 mg, & 32 mg., Rx | Mikart, Inc. | ANDA 40-316 | 4/28/99 | 5/3/99 | ||
| Acetaminophen and Codeine Tablets, 300 mg/60 mg, Rx | Able Laboratories, Inc. | ANDA 40-459 | 8/1/02 | 4/9/03 | ||
| Acetaminophen and Codeine Tablets, 300 mg/30 mg, Rx | Able Laboratories, Inc. | ANDA 40-452 | 8/1/02 | 4/9/03 | ||
| Acetaminophen and Codeine Phosphate Tablets, 500 mg/15 mg, Rx | Andrx Pharmaceuticals, L.L.C | ANDA 40-447 | 2/26/03 | |||
| Acetaminophen and Codeine Phosphate Tablets, 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg, Rx | Andrx Pharmaceuticals, Inc. | ANDA 40-443 | 1/22/03 | |||
| Acetaminophen and Codeine Tablets, 500 mg/30 mg, Rx | Andrx | ANDA 40-441 | 3/27/03 | |||
| Acetaminophen and Codeine Tablets, 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg, Rx | Mallinckrodt Inc. | ANDA 40-419 | 5/31/01 | 6/5/01 | ||
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973/S16 | 8/1/03 | 8/15/03 | ||
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973/S15 | 9/30/02 | 10/2/02 | ||
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973/S14 | 9/23/02 | 9/27/02 | ||
| ACIPHEX (rabeprazole sodium) Delayed-Release Tablets, 20 mg. | Eisai Medical Research Inc.
|
NDA 21-456 NDA 20-973/S-013 |
11/8/02 | 11/18/02 | 11/8/02 | 4/25/03 |
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973/S12 | 5/29/02 | 6/3/02 | ||
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973/S9 | 2/12/02 | 2/21/02 | 2/21/02 | |
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973/S8 | 08/15/01 | 04/25/03 | ||
| Aciphex (Rabeprazole Sodium) Delayed-Release Tablets, Rx | Eisai Inc. | NDA 20-973 | 8/19/99 | 9/24/99 | 2/8/00 | 7/3/00 |
| Aciphex Indications: 1)healing of erosive or ulcerative gastroesophageal reflux disease (GERD); 2) maintenance of healing of erosive or ulcerative GERD; 3) healing of duodenal ulcer; 4) treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. | ||||||
| ACLOVATE (alclometasone dipropionate cream) Cream, 0.05% and ACLOVATE (alclometasone dipropionate ointment) Ointment, 0.05%. | GlaxoSmithKline Consumer Health | NDA
18-702/S-007 NDA 18-707/S-008
|
3/31/03 | 4/16/03 | 4/16/03 | |
| ACOVA (argatroban) Injection, Rx | Texas Biotechnology Corporation | NDA 20-883 | 6/30/00 | 7/24/00 | 7/24/00 | 4/5/02 |
| ACOVA Indications: Anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. | ||||||
| Actigall (ursodiol) Capsules, | Novartis Pharmaceuticals Corporation | NDA 19-594/S-021 | 8/14/02 | 8/21/02 | ||
|
Actiq (oral transmucosal fentanyl
citrate), Rx (Consumer Safety Alert) |
Cephalon, Inc. | NDA 20-747/S11 | 6/10/02 | 6/17/02 | ||
| Actiq (oral transmucosal fentanyl citrate), Rx | Anesta Corporation | NDA 20-747/S10 | 3/7/02 | 3/12/02 | ||
| Actiq (oral transmucosal fentanyl citrate), Rx | Anesta Corporation | NDA 20-747/S9 | 1/29/03 | 1/30/03 | ||
| Actiq (oral transmucosal fentanyl citrate), Rx | Anesta Corporation | NDA 20-747/S8 | 2/19/03 | 2/25/03 | ||
| Actiq (oral transmucosal fentanyl citrate), Rx | Anesta Corporation | NDA 20-747/S6 | 4/11/01 | 4/8/03 | ||
| Actiq (oral transmucosal fentanyl citrate), 200, 400, 600, 800, 1200, and 1600 mcg (fentanyl base)/ (transmucosal), Rx, (Patient Package Insert) | Anesta Corporation | NDA 20-747 | 11/4/98 | 11/12/98 | 11/12/98 | 7/19/00 |
| Actiq Indication: For the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. | ||||||
| Ativan (Lorazepam) Injection, | Wyeth Laboratories | NDA 96-989/S35 & S36 | 12/12/01 | 4/11/03 | ||
| Activella (Estradiol/Norethindrone Acetate) Tablets, Rx | Novo Nordisk Pharmaceuticals, Inc. | NDA 21-103 | 4/11/00 | 4/13/00 | 4/13/00 | 10/9/02 |
| Activella Indications: for women with an intact uterus for the prevention of postmenopausal osteoporosis. | ||||||
| Activelle (estradiol/norethindrone acetate tablets), 1 mg/0.5 mg, Rx | Novo Nordisk Pharmaceuticals | NDA 20-907 | 11/18/98 | 11/18 | 11/18 | 7/8/99 |
| Actonel (risedronate sodium) Tablet, Rx | Procter & Gamble Pharmaceuticals | NDA 20-835/S14 | 2/24/04 | 2/25/04 | 4/5/04 | |
| Actonel (risedronate sodium) Tablet, 35 mg, Rx | Procter & Gamble Pharmaceuticals | NDA 20-835/S8 & S9 | 5/17/02 | 5/23/02 | ||
| Actonel (risedronate sodium) Tablet, 30 mg, Rx | Procter & Gamble | NDA 20-835 | 3/27/98 | 4/10/02 | 4/10/02 | |
| Actonel (risedronate sodium) Oral Tablet, 5 mg., Rx | Procter & Gamble | NDA 20-835/S-001, 002, 003, & 004 | 4/14/00 | 4/24/00 | 8/16/01 | 8/17/01 |
| Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Rx | Takeda | NDA 21-073/S-021 | 6/11/03 | 7/8/03 | 7/8/03 | |
| Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Rx | Takeda | NDA 21-073/S-020 | 11/26/03 | 12/4/03 | 12/8/03 | |
| Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Rx | Takeda | NDA 21-073/S-017 | 1/17/03 | 1/23/03 | ||
| Actos (pioglitazone HCl) Tablets, Rx | Takeda | NDA 21-073/S16 | 1/7/02 | 2/8/02 | ||
| Actos (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg, Rx | Takeda Pharmaceuticals North America, Inc | NDA 21-073/S-018 | 12/3/02 | 12/9/02 | ||
| Actos (pioglitazone) Tablets, Rx | Takeda | NDA 21-073/S10 | 7/12/02 | 7/15/02 | 7/15/02 | |
| Actos (or pioglitazone HCl) oral Tablets, 15 mg, 30 mg, and 45 mg, Rx | Takeda | NDA 21-073 | 7/15/99 | 7/28/99 | 7/28/99 | 6/30/00 |
| Actos Indicated: for the improvement of glycemic control in patients with Type 2 diabetes as monotherapy, or in combination with a sulfonylurea, metformin or insulin when diet and the single agent does not result in adequate glycemic control. | ||||||
| ACULAR (ketorolac tromethamine) ophthalmic solution, 0.5% | Allergan | NDA 19700/S18 | 7/6/01 | 6/16/03 | ||
| ACULAR LS (ketorolac tromethamine) ophthalmic solution, 0.4% | Allergan, Inc. | NDA 21-528 | 5/30/03 | 6/9/03 | 6/9/03 | 10/15/03 |
| Acular (Ketorolac Tromethamine Ophthalmic Solution) Sterile & Preservative-Free Sterile, 5% | Allergan, Inc. | NDA 19-700/S-019 & 20-811/S-003 | 2/8/02 | 2/19/02 | 2/19/02 | |
| AcuTect (Kit for the Preparation of Technetium Tc 99m Apcitide), Injection, 100 ug peptide, Rx | Diatide | NDA 20-887 | 9/14/98 | 9/14/98 | 9/14/98 | 7/7/99 |
| Acyclovir Capsules, 200 mg, Rx | Ranbaxy Laboratories Limited | ANDA 74-975 | 9/30/98 | 9/30/98 | 9/25/02 | |
| Acyclovir Capsules, 200 mg. | Genpharm, Inc. | ANDA 74-977 | 4/13/98 | 3/19/99 | ||
| Acyclovir Capsules USP, 200 mg | Stason Industrial Corporation | ANDA 75-090 | 1/26/99 | 1/26/99 | ||
| Acyclovir Capsules, 200 mg. | Chelsea Laboratories, Inc. | ANDA 75-101 | 4/15/98 | 3/22/99 | ||
| Acyclovir Injection, 50 mg/mL, Rx | Gensia Sicor Pharmaceuticals, Inc. | ANDA 75-627 | 3/28/01 | 3/30/01 | ||
| Acyclovir Injection, 50 mg/mL (500 mg/10 mL & 1 g/20 mL vials) | Abbott Laboratories | ANDA 75-114 | 7/26/99 | 7/29/99 | ||
| Acyclovir Tablets, 400 mg & 800 mg. | Copley Pharmaceutical, Inc. | ANDA 75-021 | 3/18/98 | 3/19/99 | ||
| Acyclovir Sodium Injection, 500 mg (base)/vial & 1 g (base)/vial | Apothecon, Inc. | ANDA 74-897 | 2/27/98 | 3/15/99 | ||
| Acyclovir Sodium Injection, 10 mL and 20 mL vials, 50 mg (base)/mL | Fujisawa USA | ANDA 74-930 | 5/13/98 | 5/13/98 | 12/17/98 | |
| Acyclovir Sodium Injection, 10 mL and 20 mL vials, 50 mg (base)/mL | Meridian Medical Technologies | ANDA 75-065 | 2/25/99 | 3/4/99 | ||
|
Acyclovir Tablets, 400 mg and
800 mg, Rx |
Mylan Pharmaceuticals | ANDA 75-211 | 9/28/98 | 9/28/98 | 8/6/03 | |
|
Acyclovir Tablets, 400 mg and
800 mg, Rx |
Ranbaxy Laboratories Limited | ANDA 74-980 | 9/30/98 | 9/30 | ||
|
Acyclovir Tablets, 400 mg and
800 mg, Rx |
Genpharm, Inc. | ANDA 74-976 | 4/13/98 | 1/8/02 | 1/8/02 | 1/8/02 |
| Acyclovir Tablets USP,400 mg & 800 mg. | Carlsbad Technology Inc. | ANDA 75-382 | 4/30/99 | 5/4/99 | ||
| ADDERALL (Mixed Salts of a Single-Entity Amphetamine Product) Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg Tablets. | Shire Pharmaceutical Development Inc. | NDA 11-522/S-030 | 11/8/02 | 11/19/02 | 10/9/03 | |
| ADDERALL CII (Mixed Salts of a Single-Entity Amphetamine Product) Tablets, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg and 30 mg, Rx | Shire Pharmaceutical Development Inc. | NDA 11-522/S-029 | 4/11/02 | |||
| Adderall XR Oral Capsule, Rx | Shire Laboratories | NDA 21-303/S1 | 5/22/02 | 5/29/02 | 5/23/02 | |
| Adderall XR Oral Capsule, Rx | Shire Laboratories | NDA 21-303 | 10/11/01 | 2/12/02 | 2/12/02 | 2/12/02 |
| Adderall Indications: ADHD (Attention Deficit Hyperactive Disorder) | ||||||
| Adenoscan (Adenosine) Injection, Rx | Fujisawa Healthcare, Inc. | NDA 20-059/S7 | 8/31/01 | 11/5/01 | 11/5/01 | 11/7/01 |
| Adenoscan Indications: Adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately. | ||||||
| Adenosine Injection, 3 mg/mL, Rx Tentatively Approved | Sicor Pharmaceuticals | ANDA 76-564 | 9/23/03 | |||
| Adenosine Injection, 3 mg/mL, Rx Tentatively Approved | Baxter Healthcare | ANDA 76-500 | 5/14/03 | |||
| Adenosine Injection, 3 mg/mL, Rx Tentatively Approved | Baxter Healthcare | ANDA 76-501 | 5/14/03 | |||
| Adenosine Injection, 3 mg/mL, 2 mL & 4 mL, Rx Tentatively Approved | Bedford Laboratories | ANDA 76-404 | ||||
| ADRIAMYCIN PFS (doxorubicin hydrochloride injection), | Pharmacia & Upjohn Company | NDA 50-467/S-064/S-067 & 50-629/S-010/S-013 | 9/25/02 | 10/2/02 | 9/27/02 | |
| Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder, | GlaxoSmithKline | NDA 21-077/S19 | 8/11/03 | 8/15/03 | 8/15/03 | |
| Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder, | GlaxoSmithKline | NDA 21-077/S17 | 4/21/04 | |||
| Advair Diskus (fluticasone propionate/salmeterol) Inhalation Powder, | GlaxoSmithKline | NDA 21-077/S8 | 8/21/02 | 8/26/02 | ||
| Advair Diskus, | GlaxoSmithKline | NDA 21-077/S3 | 11/17/03 | 11/25/03 | 12/2/03 | |
| Advair Diskus,100/50, 250/50 and 500/50, | Glaxo Wellcome. | NDA 21-077 | 8/24/00 | 2/3/03 | ||
| Advair Indications: for the long-term, twice-daily, maintenance treatment of asthma in patients 12 years of age and older. | ||||||
| Advicor (Niacin Extended Release & Lovastatin) Tablets, Rx | Kos Pharmaceuticals, Inc. | NDA 21-249/S1 | 11/4/03 | 11/13/03 | ||
| Advicor (Niacin & Lovastatin) Tablets, Rx | Kos Pharmaceuticals, Inc. | NDA 21-249 | 12/17/01 | 9/13/02 | 9/13/02 | 9/13/02 |
|
Advil, Children's Suspension |
Whitehall-Robins Healthcare | NDA 20-589/S13 | 8/2/01 | 4/25/03 | ||
| Advil, | Wyeth Consumer | NDA 18-989/S56 | 9/26/03 | |||
| Advil | Wyeth Consumer | NDA 18-989/S55 | 9/26/03 | 9/30/03 | 9/30/03 | |
| Advil | Whitehall-Robins Healthcare | NDA 18-989/S53 | 9/07/01 | 4/23/03 | ||
| Advil, Children's Suspension | Whitehall-Robins Healthcare | NDA 18-822/S11 | 1/26/98 | 9/11/03 | ||
| Advil Allergy Sinus (ibuprofen 200 mg, pseudoephedrine 30 mg and chlorpheniramine 2 mg) Caplet, OTC | Wyeth Consumer Healthcare | NDA 21-441 | 12/19/02 | 1/29/03 | 4/9/03 | 4/21/04 |
| Advil Chewable Tablets (ibuprofen tablet), 50 mg and 100 mg | Whitehall-Robins Healthcare | NDA 20-944 | 12/18/98 | 7/18/01 | 7/18/01 | 7/18/01 |
| Advil Indication: Temporary reduction of fever and relief of minor aches and pains due the common cold, flu, sore throat, headaches and toothaches. | ||||||
| Advil Cold & Sinus Caplets, | Wyeth Consumer Healthcare | NDA 19-771/S22 | 10/17/03 | 10/22/03 | ||
| Advil Cold & Sinus, OTC | Wyeth Consumer Healthcare | NDA 19-971/S20 | 5/23/01 | 6/10/03 | ||
| Advil Cold & Sinus Liquigels (200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride capsules), | Wyeth Consumer Healthcare | NDA 21-374/S1 | 10/17/03 | 10/22/03 | 10/22/03 | |
| Advil Cold & Sinus Liquigels (200 mg ibuprofen and 30 mg pseudoephedrine hydrochloride capsules), | Wyeth Consumer Healthcare | NDA 21-374 | 5/30/02 | 6/17/02 | 5/31/02 | 2/3/03 |
| Advil Liqui- Gels & Migraine Liqui-Gels (ibuprofen), 200 mg, OTC | Wyeth Consumer | NDA 20-402/S11 | 2/26/04 | 2/27/04 | ||
| Advil Migraine Liqui-Gels (solubolized ibuprofen), 200 mg, OTC | Whitehall-Robins Healthcare | NDA 20-402/S-005 | 3/16/00 | 3/31/00 | 3/31/00 | 7/8/03 |
| Advil Indication: Treats migraine | ||||||
| Aerobid/Aerobid M (flunisolide) Inhaler System, | Syntex (USA) Inc. | NDA 18-340/S-021 | 11/26/03 | 12/2/03 | ||
| Agenerase (amprenavir) Capsules and Oral Solution, | GlaxoSmithKline | NDA 21-007/S16 NDA 21-039/S16 |
2/12/04 | 3/3/04 | 4/5/04 | |
| Agenerase (amprenavir) Capsules and Oral Solution, | GlaxoSmithKline | NDA 21-007/S14
& S15 NDA 21-039/S13 & S14 |
10/2/02 | 10/11/01 | 10/3/02 | |
| Agenerase (amprenavir) Capsules and Oral Solution, | GlaxoSmithKline | NDA 21-007/S11 NDA 21-039/S10 |
8/2/02 | 8/6/02 | 8/5/02 | |
| Agenerase (amprenavir) Capsules and Oral Solution, | GlaxoSmithKline | NDA 21-007/S10, & 13 NDA 21-039/S9 & 12 |
2/5/02 | 4/17/02 | ||
| Agenerase (amprenavir) Capsules and Oral Solution, 50mg, 150mg | Glaxo Wellcome | NDA 21-007 NDA 21-039 |
4/15/99 | 7/24/02 | 5/25/99 | 7/24/02 |
| Agenerase Indication: for the treatment of HIV-1 infection. | ||||||
| Agenerase (amprenavir) Capsules and Oral Solution, Rx | GlaxoSmithKline | NDA 21-007/S6 NDA 21-039/S6 |
5/11/01 | 12/18/01 | 12/18/01 | 12/18/01 |
| Aggrastat (tirofiban hydrochloride) Premixed Injection, 0.05 mg/mL, Rx | Merck & Co., Inc. | NDA 20-913/S10 | 5/17/02 | 5/23/02 | ||
| Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Rx | Merck & Co., Inc. | NDA 20-913/S9 & 20-912/S12 | 6/17/02 | 7/24/03 | ||
| Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Rx | Merck & Co., Inc. | NDA 20-913/S8 & 20-912/S9 | 7/24/02 | 8/6/02 | ||
| Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Rx | Merck & Co., Inc. | NDA 20-913/S7 & 20-912/S8 | 9/25/01 | 4/22/02 | 4/22/02 | |
| Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection,12.5 mg per 50 mL vial & Premixed 25 mg per 500 mL single dose container, Rx | Merck | NDA 20-913/S6 & 20-912/S7 | 3/23/01 | 4/25/01 | ||
| Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Rx | Merck | NDA 20-913/S4 & 20-912/S4 | 1/11/00 | 6/6/01 | ||
| Aggrastat (tirofiban hydrochloride) Injection & Premixed Injection, Rx | Merck | NDA 20-913/S1 & 20-912/S1 | 7/9/99 | 7/2/01 | 7/2/01 | 7/2/01 |
| Aggrastat (tirofiban hydrochloride) Premixed Injection, Rx | Merck | NDA 20-912/S13 | 2/28/03 | 3/10/03 | ||
| Aggrastat (tirofiban hydrochloride) Injection Premixed 25 mg per 500 mL single dose container | Merck | NDA 20- 912 & 20-913 | 5/14/98 | 5/15/98 | 5/15/98 | |
| Aggrenox (aspirin/extended-release dipyridamole) Capsules, | Boehringer Ingelheim Pharmaceuticals | NDA 20-884/S7 | 1/28/04 | 2/2/04 | ||
| Aggrenox (aspirin/extended-release dipyridamole) Capsules | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA 20-884A | 11/23/99 | 4/23/03 | ||
| Aggrenox (aspirin/extended-release dipyridamole) Capsules. | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA 20-884 | 11/23/99 | 12/30/99 | 12/30/99 | 7/2/01 |
| Aggrenox (aspirin/extended-release dipyridamole) Capsules | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA 20-884/S1 | 08/10/01 | 04/24/03 | ||
| Aggrenox (aspirin/extended-release dipyridamole) Capsules,25 mg/200 mg. | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA 20-884/S-003 | 5/1/01 | |||
|
Agrylin (anagrelide hydrochloride)
Capsules(not a new route of administration), Rx |
Roberts Laboratories, Inc. | NDA 20-333/SE1-002 | 12/16/98 | 12/16 | 12/16 | 5/22/01 |
|
Agrylin Indication: Agrylin
Capsules are indicated for the treatment of patients with Essential Thrombocythemia to
reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated
symptoms. Expanded indication: Agrylin Capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events. |
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| Akineton (biperiden HCI) 2 mg Tablets | Knoll Pharmaceutical Company | NDA 12-003/S-018/S-019/S-020/S-021 & 12-418/S-006/S-007/S-008/S-009 | 7/23/01 | 10/10/02 | ||
| Akineton (biperiden) Tablet, 2 mg | Abbott Laboratories | NDA 12-003/S-024 | 2/4/02 | 4/16/02 | ||
| Alamast (pemirolast potassium ophthalmic solution), 0.1%, Rx | Santen Inc. | NDA 21-079 | 9/24/99 | 6/5/00 | 6/5/00 | 7/31/02 |
| Alavert (loratadine) Orally Disintegrating Tablets, Rx (Tentative Approval) | Whitehall-Robbins | NDA 21-375 | 12/12/02 | |||
| Alavert (loratadine) Orally Disintegrating Tablets, OTC | Wyeth Consumer Healthcare | NDA 21-375 | 12/19/02 | 1/29/03 | 10/14/02 | 3/24/04 |
| Albuterol Extended-release Tablets, 4 & 8 mg, Rx | Sidmak Laboratories, Inc. | ANDA 76-130 | 9/26/02 | |||
| Albuterol Sulfate Inhalation Solution, 0.083% (base), | Breath Limited | ANDA 76-370 | 11/24/03 | |||
| Albuterol Sulfate Inhalation Solution, 0.0417% (base), Tentatively Approved | Nephron Pharmaceuticals Corporation | ANDA 76-355 | 11/7/03 | |||
| Albuterol Sulfate Inhalation Solution, 0.5% (base) | Nephron Pharmaceuticals Corporation | ANDA 74-664 | 6/26/01 | 4/14/03 | ||
| Albuterol Sulfate Inhalation Solution, 0.5% (base) | Hi-Tech Pharmacal | ANDA 74-543 | 1/15/98 | 4/27/98 | ||
| Albuterol Sulfate Inhalation Solution, 0.5% (Base) | Bausch & Lomb Pharmaceuticals | ANDA 75-050 | 6/18/98 | 6/18/98 | ||
| Albuterol Sulfate Inhalation Solution, 0.083% (base) | Hi-Tech Pharmacal | ANDA 75-063 | 2/9/99 | 2/10/99 | 4/27/99 | |
| Albuterol Sulfate Inhalation Solution, 0.083% (base), Rx | Roxane Laboratories, Inc. | ANDA 75-129 | 2/13/01 | 3/6/01 | ||
| Albuterol Sulfate Inhalation Solution, 0.083% (base) | Zenith Goldline Pharmaceuticals, Inc. | ANDA 75-343 | 11/9/99 | 12/30/99 | 7/11/01 | |
| Albuterol Sulfate Inhalation Solution, 0.083% (base), Rx | Bausch & Lomb Pharmaceuticals | ANDA 75-358 | 3/29/00 | 3/31/00 | 12/18/01 | 12/18/01 |
| Albuterol Sulfate I | ||||||