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Tentative Approvals - November 2003
| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-355 |
ALBUTEROL SULFATE INHALATION SOLUTION, USP 0.042% (BASE) PACKAGED IN 1.5 MG (BASE)/3 ML UNIT-DOSE VIALS |
NEPHRON PHARMACEUTICALS CORPORATION |
11/7/2003 |
| 2 |
76-118 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
KV PHARMACEUTICAL COMPANY |
11/7/2003 |
| 3 |
76-211 |
BENAZEPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND 40 MG |
TEVA PHARMACEUTICALS USA |
11/7/2003 |
| 4 |
76-507 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
11/12/2003 |
| 5 |
75-477 |
GABAPENTIN CAPSULES 100 MG, 300 MG, AND 400 MG |
IVAX PHARMACEUTICALS, INC. |
11/24/2003 |
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Date created: 12/8/2003 |
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