Drug Information |
ANDA Number | Drug Name | Applicant | Tentative Approval Date | |
---|---|---|---|---|
1 | 75-416 | NAPROXEN SODIUM EXTENDED-RELEASE TABLETS 375 MG (BASE) | ANDRX PHARMACEUTICALS, INC. | 7/5/01 |
2 | 75-794 | ACETAMINOPHEN, ASPIRIN, AND CAFFEINE TABLETS 250 MG/250 MG/65 MG | PERRIGO COMPANY | 7/12/01 |
3 | 75-300 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | GENEVA PHARMACEUTICALS, INC. | 7/18/01 |
4 | 75-451 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | MYLAN PHARMACEUTICALS, INC. | 7/18/01 |
5 | 75-551 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | TEVA PHARMACEUTICALS USA | 7/18/01 |
6 | 75-636 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | EON LABS MANUFACTURING, INC. | 7/18/01 |
7 | 75-685 | CIPROFLOXACIN TABLETS, USP 250 MG, AND 500 MG (NOTE: 750 MG STRENGTH WAS PREVIOUSLY T/A'ED) | MYLAN PHARMACEUTICALS, INC. | 7/18/01 |
8 | 75-935 | LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG | GENPHARM INC. | 7/18/01 |
9 | 75-565 | LORATADINE SYRUP 10 MG/10 ML | NOVEX PHARMA | 7/30/01 |
10 | 75-882 | FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG | BARR LABORATORIES, INC. | 7/31/01 |
FDA/Center for Drug Evaluation and Research
Last Updated: August 15, 200125 Apr 2006 08:49:29 -0400
Originator: OGC
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