|
| ANDA Number
| Generic Drug Name
| Applicant
| Approval Date
|
| 1 |
65-116 |
BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
12/3/02 |
| 2 |
76-004 |
TABLETS, USP 400 MG AND 500 MG |
TORPHARM |
12/3/02 |
| 3 |
65-119 |
AMOXICILLIN FOR ORAL SUSPENSION, USP 200 MG/5 ML AND 400 MG/5 ML |
TEVA PHARMACEUTICALS USA |
12/4/02 |
| 4 |
75-499 |
BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML; 2.5 ML METERED-DOSE SPRAY PUMP |
NOVEX PHARMA |
12/4/02 |
| 5 |
65-098 |
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG
(BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML |
LEK PHARMACEUTICALS, D.D. |
12/16/02 |
| 6 |
76-186 |
AMANTADINE HYDROCHLORIDE TABLETS 100 MG |
UPSHER-SMITH LABORATORIES, INC. |
12/16/02 |
| 7 |
76-328 |
METFORMIN HYDROCHLORIDE TABLETS 500 MG 850 MG 1000 MG |
TEVA PHARMACEUTICALS USA |
12/16/02 |
| 8 |
65-111 |
KANAMYCIN INJECTION, USP 500 MG/2 ML VIAL, AND 1 G/3 ML VIAL |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
12/17/02 |
| 9 |
75-853 |
DILTIAZEM HYDROCHLORIDE FOR INJECTION 100 MG ADD-VANTAGE VIALS |
ABBOTT LABORATORIES |
12/17/02 |
| 10 |
75-638 |
KETOCONAZOLE CREAM 2% |
TARO PHARMACEUTICALS USA, INC. |
12/18/02 |
| 11 |
75-808 |
NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.180 MG/0.035 MG; 0.215 MG/0.035 MG;
0.250 MG/0.035 MG PACKAGED IN A 28-DAY REGIMEN |
BARR LABORATORIES, INC. |
12/18/02 |
| 12 |
76-263 |
DIFLORASONE DIACETATE CREAM, USP (EMOLLIENT) 0.05% |
ALTANA INC. |
12/20/02 |
| 13 |
76-296 |
VINCRISTINE SULFATE INJECTION, USP (PRESERVATIVE-FREE) 1 MG/ML AND 2 MG/2ML
SINGLE-DOSE VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
12/20/02 |
| 14 |
75-181 |
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML |
WE PHARMACEUTICALS, INC. |
12/23/02 |
| 15 |
75-791 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG AND 20 MG |
EON LABS, INC. |
12/23/02 |
| 16 |
76-123 |
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML |
PHARMACEUTICAL ASSOCIATES, INC. |
12/23/02 |
| 17 |
76-041 |
ISOTRETINOIN CAPSULES, USP 10 MG, 20 MG, AND 40 MG |
RANBAXY LABORATORIES LIMITED |
12/24/02 |
| 18 |
40-457 |
PYRIDOSTIGMINE BROMIDE TABLETS, USP 60 MG |
COREPHARMA LLC |
12/26/02 |
| 19 |
75-836 |
CALCITRIOL INJECTION 0.001 MG/ML, AND 0.002 MG/ML |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
12/31/02 |
