|
| 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 |
