|
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 |