Drug Information |
ANDA Number | Drug Name | Applicant | Approval Date | |
---|---|---|---|---|
1 | 75-810 | FLUOXETINE HYDROCHLORIDE TABLETS 10 MG (BASE) | BARR LABORATORIES, INC. | 2/1/02 |
2 | 76-165 | FLUOXETINE CAPSULES, USP 10 MG, AND 20 MG | RANBAXY LABORATORIES LIMITED | 2/1/02 |
3 | 40-321 | METHYLPHENIDATE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 20 MG | PUREPAC PHARMACEUTICAL CO. | 2/5/02 |
4 | 40-428 | PROMETHAZINE HYDROCHLORIDE SUPPOSITORIES, USP 25 MG | G &W LABORATORIES, INC. | 2/5/02 |
5 | 76-097 | CARTEOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, USP 1% | NOVEX PHARMA | 2/6/02 |
6 | 76-114 | INDOMETHACIN EXTENDED-RELEASE CAPSULES, USP 75 MG | ABLE LABORATORIES, INC. | 2/6/02 |
7 | 75-292 | FLUOXETINE ORAL SOLUTION, USP 20 MG(BASE)/5 ML | NOVEX PHARMA | 2/7/02 |
8 | 75-364 | KETOPROFEN TABLETS 12.5 MG TABLETS AND CAPLETS | L. PERRIGO COMPANY | 2/7/02 |
9 | 76-193 | PROPAFENONE HYDROCHLORIDE TABLETS 150 MG, 225 MG, AND 300 MG | KV PHARMACEUTICAL COMPANY | 2/7/02 |
10 | 40-422 | AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL), 20 MG (TOTAL) AND 30 MG (TOTAL) | BARR LABORATORIES, INC. | 2/11/02 |
11 | 75-281 | DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 50 MG, AND 75 MG | ALPHAPHARM PTY. LTD. | 2/12/02 |
12 | 65-043 | CEFUROXIME AXETIL TABLETS , USP 125 MG (BASE), 250 MG (BASE), AND 500 MG (BASE). | RANBAXY LABORATORIES, LTD. | 2/15/02 |
13 | 75-997 | MEGESTROL ACETATE ORAL SUSPENSION 40 MG/ML | ROXANE LABORATORIES, INC. | 2/15/02 |
14 | 74-805 | FLUNISOLIDE NASAL SOLUTION, USP 0.025% (25 MCG/SPRAY), 200 METERED SPRAY CONTAINER | BAUSCH & LOMB PHARMACEUTICALS | 2/20/02 |
15 | 75-679 | KETOPROFEN EXTENDED-RELEASE CAPSULES 100 MG, 150 MG, AND 200 MG | MYLAN PHARMACEUTICALS, INC. | 2/20/02 |
16 | 76-175 | MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG | GENEVA PHARMACEUTICALS TECHNOLOGY CORP. | 2/20/02 |
17 | 75-470 | DICLOFENAC POTASSIUM TABLETS 50 MG | MUTUAL PHARMACEUTICAL COMPANY, INC. | 2/21/02 |
18 | 75-911 | LACTULOSE SOLUTION, USP 10 G/15 ML | NOVEX PHARMA | 2/21/02 |
19 | 76-038 | METFORMIN HYDROCHLORIDE TABLETS 500 MG, 850 MG, AND 1000 MG | MUTUAL PHARMACEUTICAL COMPANY, INC. | 2/21/02 |
20 | 65-087 | TOBRAMYCIN OPHTHALMIC SOLUTION, USP 0.3% | NOVEX PHARMA | 2/25/02 |
21 | 75-280 | NABUMETONE TABLETS 500 MG 750 MG | EON LABS MANUFACTURING, INC. | 2/25/02 |
22 | 75-590 | NABUMETONE TABLETS 500 MG AND 750 MG | GENEVA PHARMACEUTICALS TECHNOLOGY CORP. | 2/25/02 |
23 | 75-874 | IFOSFAMIDE INJECTION/MESNA INJECTION KIT 50 MG/ML (1 G/20 ML OR 3 G/60 ML), AND 100 MG/ML (1 G/10 ML), RESPECTIVELY | GENSIA SICOR PHARMACEUTICALS, INC. | 2/26/02 |
24 | 65-022 | BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINT, USP 500 UNITS/G AND 10,000 UNITS/G, RESPECTIVELY | ALTANA INC. | 2/27/02 |
25 | 75-572 | BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG | KV PHARMACEUTICAL CO. | 2/27/02 |
26 | 75-948 | CARBAMAZEPINE TABLETS, USP 200 MG | APOTEX INC. | 2/27/02 |
27 | 75-022 | BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG | TEVA PHARMACEUTICALS USA | 2/28/02 |
28 | 75-865 | FLUOXETINE HYDROCHLORIDE TABLETS 10 MG | ZENITH GOLDLINE PHARMACEUTICALS, INC. | 2/28/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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