Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: January 2, 2003
Originator: OTCOM/OGD
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