Drug Information |
ANDA Number | Generic Drug Name | Applicant | Approval Date | |
---|---|---|---|---|
1 | 40-452 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/30 MG | ABLE LABORATORIES, INC. | 8/1/02 |
2 | 40-459 | ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300 MG/60 MG | ABLE LABORATORIES, INC. | 8/1/02 |
3 | 76-233 | PACLITAXEL INJECTION 6 MG/ML (PACKAGED IN 30 MG/5 ML, 100 MG/16.7 ML, 150 MG/25 ML, AND 300 MG/50 ML MULTIPLE-DOSE VIALS) | NAPRO BIOTHERAPEUTICS, INC. | 8/1/02 |
4 | 75-942 | FAMOTIDINE INJECTION 10 MG/ML (PACKAGED IN 40 MG/4 ML AND 200 MG/20 ML MULTIPLE-DOSE VIALS) | APOTEX CORP. | 8/2/02 |
5 | 76-002 | CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM, USP 1%/0.05% | ALPHARMA | 8/2/02 |
6 | 76-013 | MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; PACKAGED IN 10 MG (BASE)/10 ML AND 20 MG (BASE)/20 ML SINGLE-DOSE VIALS | INTERNATIONAL MEDICATION SYSTEMS, LTD. | 8/2/02 |
7 | 76-202 | PENTAZOCINE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS 25 MG (BASE)/650 MG | AMIDE PHARMACEUTICAL, INC. | 8/2/02 |
8 | 40-446 | MEPERIDINE HYDROCHLORIDE TABLETS, USP 50 MG AND 100 MG | CARACO PHARMACEUTICAL LABORATORIES LTD. | 8/8/02 |
9 | 76-259 | MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML | ESI LEDERLE | 8/8/02 |
10 | 76-070 | NIFEDIPINE EXTENDED-RELEASE TABLETS, USP 90 MG | BIOVAIL LABORATORIES, INC. | 8/16/02 |
11 | 40-454 | PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML AND 50 MG/ML | GENSIA SICOR PHARMACEUTICALS, INC. | 8/22/02 |
12 | 76-021 | TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) | RANBAXY LABORATORIES LIMITED | 8/22/02 |
13 | 75-514 | FLUOXETINE ORAL SOLUTION, USP 20 MG (BASE)/5 ML | MORTON GROVE PHARMACEUTICALS, INC. | 8/29/02 |
14 | 65-079 | PENICILLIN G POTASSIUM FOR INJECTION, USP 1 MILLION UNITS/VIAL, 5 MILLION UNITS/VIAL, AND 20 MILLION UNITS/VIAL. | BIOCHEMIE GmbH | 8/30/02 |
15 | 75-478 | NORETHINDRONE AND ETHINYL ESTRADIOL TABLETS, USP 0.5 MG/0.035 MG; 0.75 MG/0.035 MG; AND 1 MG/0.035 MG PACKAGED IN 21-DAY AND 28-DAY REGIMENS | BARR LABORATORIES, INC. | 8/30/02 |
16 | 76-029 | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE CHEWABLE TABLETS 2 MG/125 MG | L. PERRIGO COMPANY | 8/30/02 |
17 | 76-132 | RIMANTADINE HYDROCHLORIDE TABLETS 100 MG | IMPAX LABORATORIES, INC. | 8/30/02 |
18 | 76-195 | RANITIDINE TABLETS, USP (OTC) 75 MG (BASE) | L. PERRIGO COMPANY | 8/30/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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