| |
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
75-852 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML |
BAXTER PHARMACEUTICAL PRODUCTS, INC. |
8/2/01 |
| 2 |
75-022 |
BUSPIRONE HYDROCHLORIDE TABLETS, USP 15 MG (NOTE: 5 MG & 10 MG STRENGTHS WERE PREVIOUSLY
TENTATIVELY APPROVED). |
TEVA PHARMACEUTICALS, USA |
8/3/01 |
| 3 |
75-903 |
LISINOPRIL TABLETS, USP 2.5 MG 5 MG 10 MG, 20 MG 30 MG AND 40 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
8/14/01 |
| 4 |
76-030 |
FLECAINIDE ACETATE TABLETS, USP 50 MG, 100 MG, AND 150 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
8/20/01 |
| 5 |
75-761 |
AMIODARONE HYDROCHLORIDE INJECTION 50 MG/ML (3 ML VIALS) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
8/23/01 |
| 6 |
76-006 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) |
DR. REDDY'S LABORATORIES LIMITED |
8/23/01 |
| 7 |
75-773 |
PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
8/24/01 |
| 8 |
76-016 |
FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML |
ESI LEDERLE |
8/24/01 |
| 9 |
75-810 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) |
BARR LABORATORIES, INC. |
8/31/01 |
| 10 |
75-817 |
CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG |
GENPHARM INC. |
8/31/01 |
