| |
ANDA Number |
Drug Name |
Applicant |
Approval Date |
| 1 |
74-803 |
FLUOXETINE CAPSULES, USP 20 MG |
BARR LABORATORIES, INC. |
8/2/01 |
| 2 |
75-049 |
FLUOXETINE CAPSULES, USP 10 MG |
GENEVA PHARMACEUTICALS, INC. |
8/2/01 |
| 3 |
75-465 |
FLUOXETINE CAPSULES, USP 40 MG |
DR. REDDY'S LABORATORIES LIMITED |
8/2/01 |
| 4 |
75-506 |
FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML |
TEVA PHARMACEUTICALS, USA |
8/2/01 |
| 5 |
75-755 |
FLUOXETINE HYDROCHLORIDE TABLETS 10 MG, AND 20 MG |
ALPHAPHARM PTY. LTD. |
8/2/01 |
| 6 |
75-720 |
METIPRANOLOL OPHTHALMIC SOLUTION 0.3% |
FALCON PHARMACEUTICALS, LTD. |
8/6/01 |
| 7 |
75-759 |
BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML (1 MG/SPRAY); 2.5 ML METERED-DOSE SPRAY PUMP |
ESI LEDERLE |
8/8/01 |
| 8 |
65-013 |
TOBRAMYCIN FOR INJECTION, USP 1.2 G PHARMACY BULK PACKAGE |
PHARMA-TEK INC. |
8/17/01 |
| 9 |
75-758 |
FAMOTIDINE TABLETS, USP (OTC) 10 MG |
DR. REDDY'S LABORATORIES LIMITED |
8/17/01 |
| 10 |
75-851 |
OXAPROZIN TABLETS 600 MG |
MYLAN PHARMACEUTICALS, INC. |
8/17/01 |
| 11 |
75-918 |
FLUPHENAZINE DECANOATE INJECTION, USP 25 MG/ML |
APOTEX CORP. |
8/17/01 |
| 12 |
40-424 |
SPIRONOLACTONE TABLETS, USP 25 MG, 50 MG, AND 100 MG |
MYLAN PHARMACEUTICALS, INC. |
8/20/01 |
| 13 |
74-911 |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE & CODEINE PHOSPHATE CAPS 50MG/325MG/40MG/30MG |
AMARIN PHARMACEUTICALS, INC. |
8/22/01 |
| 14 |
75-733 |
CLOBETASOL PROPIONATE CREAM, USP (EMOLLIENT) 0.05% |
STIEFEL LABORATORIES, INC. |
8/22/01 |
| 15 |
40-362 |
PREDNISONE TABLETS, USP 5 MG, AND 10 MG |
TRIGEN LABORATORIES, INC. |
8/29/01 |
| 16 |
76-035 |
HALOPERIDOL INJECTION, USP 5 MG (BASE)/ML; 1 ML SINGLE-DOSE VIALS AND 10 ML MULTIPLE-DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
8/29/01 |
| 17 |
76-045 |
LORAZEPAM TABLETS, USP 0.5 MG, 1 MG, AND 2 MG |
RANBAXY LABORATORIES LIMITED |
8/29/01 |
| 18 |
40-402 |
PHENTERMINE HYDROCHLORIDE TABLETS, USP 37.5 MG |
ABLE LABORATORIES, INC. |
8/30/01 |
| 19 |
40-403 |
PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG (YELLOW) |
ABLE LABORATORIES, INC. |
8/30/01 |
| 20 |
40-427 |
PHENTERMINE HYDROCHLORIDE CAPSULES, USP 30 MG (BLUE/CLEAR) |
ABLE LABORATORIES, INC. |
8/30/01 |
| 21 |
75-826 |
PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 MG/ML (1 ML VIAL) |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
8/31/01 |
