Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: September 06, 200125 Apr 2006 08:49:40 -0400
Originator: OGC
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