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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 |
|---|---|---|---|---|---|---|
| Warfarin Sodium Tablets USP, 1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 7.5mg, 10mg | Taro Pharmaceuticals USA Inc. | ANDA 40-301 | 6/15/99 | 7/29/99 | 7/23/03 | |
| Welchol (colesevelam hydrochloride) Tablets, Rx | Sankyo Pharma | NDA 21-176/S10 | 11/17/03 | 11/25/03 | 12/2/03 | |
| Welchol (colesevelam hydrochloride) Tablets, Rx | Sankyo Pharma Inc. | NDA 21-176/S9 | 10/10/03 | 10/16/03 | 10/16/03 | |
| Welchol (colesevelam hydrochloride) Tablets, Rx | Sankyo Pharma Inc. | NDA 21-176/S-008 | 8/21/03 | 8/28/03 | 8/28/03 | |
| Welchol (colesevelam hydrochloride) Tablets, Rx | Sankyo Pharma Inc. | NDA 21-176/S-005 | 10/17/02 | 10/21/02 | 10/17/02 | |
| Welchol (colesevelam hydrochloride) Tablets, Rx | Sankyo Pharma Inc. | NDA 21-176/S-004 | 2/11/03 | 2/12/03 | 2/13/03 | |
| Welchol (colesevelam hydrochloride), 375mg oral capsules, 625mg oral tablets, Rx | GelTex Pharmaceuticals Inc. | NDA 21-141 NDA 21-176 |
5/26/00 | 6/6/00 | 6/6/00 | 4/11/02 |
| Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, Rx | GlaxoSmithKline | NDA 18-644/S-026 & 20-358/S-029 | 10/22/02 | 10/28/02 | ||
| Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, 75 mg and 100 mg & 100 mg and 150 mg respectively | GlaxoSmithKline | NDA 18-644/S-022/S-024 & 20-358/S-018/S-024 | 10/2/02 | 10/2/02 | ||
| Wellbutrin (bupropion hydrochloride) Immediate-Release & Sustained-Release Tablets, 75 mg and 100 mg & 100 mg and 150 mg respectively | Glaxo SmithKline | NDA 18-644/S-022/S-023 & 20-358/S-018/S-023 | 6/20/02 | 6/24/02 | ||
| Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100, 150 & 200 mg, | GlaxoSmithKline | NDA 20-358/S30 | 4/26/04 | |||
| Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100 & 150 mg, | GlaxoSmithKline | NDA 20-358/S28 | 7/12/02 | 7/15/02 | ||
| Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, | Glaxo Wellcome Inc. | NDA 20-358/S27 | 6/14/02 | 6/17/02 | 6/14/02 | |
| Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100 & 150 mg | Glaxo Wellcome | NDA 20-358/S25 | 2/13/02 | |||
| Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets, 100 & 150 mg | Glaxo Wellcome | NDA 20-358/S19 | 6/11/01 | 11/6/01 | 11/6/01 | 11/28/01 |
| Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, | GlaxoSmithKline | NDA 21-515 | 8/28/03 | 09/09/03 | ||
| Wellbutrin (bupropion hydrochloride) Tablets | GlaxoSmithKline | NDA 18644/SCM-025 | 2/12/02 | 3/7/02 | ||
| Westcort (hydrocortisone valerate) Cream, 0.2% | Bristol-Myers Squibb Pharmaceutical Research Institute | NDA 17-950/S021 | 3/24/03 | 3/25/03 | 3/25/03 | |
| Westcort (hydrocortisone valerate) Ointment, 0.2% | Bristol-Myers Squibb Pharmaceutical Research Institute | NDA 18-726/S9 & S12 | 9/3/02 | 9/11/02 | 9/5/02 | |
| Winstrol (stanozolol) Tablets, | Ovation Pharmaceuticals | NDA 12-885/S-037 | 11/17/03 | 11/25/03 |
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