Drug Information |
ANDA Number | Generic Drug Name | Applicant | Approval Date | |
---|---|---|---|---|
1 | 75-410 | OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG | KREMERS URBAN DEVELOPMENT COMPANY | 11/1/02 |
2 | 40-376 | EDETATE DISODIUM INJECTION, USP 150 MG/ML; PACKAGED IN 20 ML SINGLE-DOSE VIALS | APOTEX CORP. | 11/4/02 |
3 | 65-109 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE) | RANBAXY LABORATORIES LIMITED | 11/4/02 |
4 | 40-473 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 10 MG/500 MG | ABLE LABORATORIES, INC. | 11/6/02 |
5 | 40-477 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/500 MG | ABLE LABORATORIES, INC. | 11/6/02 |
6 | 76-201 | DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS 100 MG | DEXCEL LTD. | 11/6/02 |
7 | 76-329 | AMCINONIDE LOTION 0.1% | ALTANA INC. | 11/6/02 |
8 | 40-478 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MG | ABLE LABORATORIES, INC. | 11/8/02 |
9 | 75-785 | OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG | IMPAX LABORATORIES, INC. | 11/8/02 |
10 | 75-945 | ISOTRETINOIN CAPSULES, USP 10 MG, 20 MG, AND 40 MG | GENPHARM INC. | 11/8/02 |
11 | 75-947 | GLYBURIDE TABLETS USP (MICRONIZED) 1.5 MG, 3 MG, AND 6 MG | AMIDE PHARMACEUTICAL, INC. | 11/14/02 |
12 | 76-295 | VALPROATE SODIUM INJECTION 500 MG/5 ML SINGLE-USE VIAL | BEDFORD LABORATORIES | 11/14/02 |
13 | 75-713 | CLOZAPINE TABLETS 25 MG AND 100 MG | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 11/15/02 |
14 | 76-096 | AMCINONIDE OINTMENT, USP 0.1% | ALTANA INC. | 11/19/02 |
15 | 65-071 | CEFOTAXIME FOR INJECTION, USP 10 G PHARMACY BULK PACKAGE | HIKMA FARMACEUTICA (PORTUGAL), LDA. | 11/20/02 |
16 | 65-072 | CEFOTAXIME FOR INJECTION, USP 500 MG, 1 G, AND 2 G VIALS; AND 1 G AND 2 G INFUSION BOTTLES | HIKMA FARMACEUTICA (PORTUGAL), LDA. | 11/20/02 |
17 | 40-471 | PROMETHAZINE HYDROCHLORIDE INJECTION, USP 25 MG/ML, PACKAGED IN 10 ML MULTIPLE-DOSE VIALS | PHARMAFORCE , INC. | 11/21/02 |
18 | 65-093 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG/125 MG (BASE) | LEK PHARMACEUTICALS, D.D. | 11/21/02 |
19 | 75-980 | TRAMADOL HYDROCHLORIDE TABLETS 50 MG | ALPHAPHARM PTY. LTD. | 11/21/02 |
20 | 76-005 | ECONAZOLE NITRATE CREAM 1% | TARO PHARMACEUTICALS USA, INC. | 11/26/02 |
21 | 76-075 | ECONAZOLE NITRATE CREAM 1% | ALTANA INC. | 11/26/02 |
22 | 76-399 | TIZANIDINE HYDROCHLORIDE TABLETS 2 MG (BASE) | EON LABS, INC. | 11/26/02 |
23 | 65-117 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG/125 MG (BASE) | LEK PHARMACEUTICALS D.D. | 11/27/02 |
24 | 75-769 | DIPYRIDAMOLE INJECTION 5 MG/ML (PACKAGED IN 10 MG/2 ML & 50 MG/10 ML SINGLE-USE VIALS | APOTEX CORP. | 11/27/02 |
25 | 76-061 | PERGOLIDE MESYLATE TABLETS 0.05 MG (BASE), 0.25 MG (BASE), AND 1 MG (BASE) | TEVA PHARMACEUTICALS USA | 11/27/02 |
26 | 76-322 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML PACKAGED IN 500 MG/50 ML PHARMACY BULK PACKAGES | APOTEX CORP. | 11/27/02 |
27 | 76-324 | FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (PACKAGED IN 20 MG/2 ML SINGLE-USE VIALS) | APOTEX CORP. | 11/27/02 |
28 | 65-113 | AMOXICILLIN FOR ORAL SUSPENSION, USP 200 MG/5 ML AND 400 MG/5 ML | RANBAXY LABORATORIES LIMITED | 11/29/02 |
29 | 65-120 | TOBRAMYCIN INJECTION, USP (PHARMACY BULK PACKAGE) 40 MG/ML, PACKAGED IN 2 G/50 ML VIALS | AMERICAN PHARMACEUTICAL PARTNERS, INC. | 11/29/02 |
30 | 65-122 | TOBRAMYCIN INJECTION, USP 10 MG/ML (20 MG/2 ML MULTIPLE- DOSE VIALS); AND 40 MG/ML (80 MG/2 ML MULTIPLE-DOSE VIALS) | AMERICAN PHARMACEUTICAL PARTNERS, INC. | 11/29/02 |
31 | 76-185 | DIMETHYL SULFOXIDE IRRIGATION, USP 50% | BIONICHE PHARMA (CANADA) LTD. | 11/29/02 |
32 | 76-362 | AMIODARONE HYDROCHLORIDE TABLETS 400 MG | TARO PHARMACEUTICAL INDUSTRIES, LTD. | 11/29/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: December 10, 2002
Originator: OTCOM/OGD
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