Drug Information |
ANDA Number | Generic Drug Name | Applicant | Approval Date | |
---|---|---|---|---|
1 | 65-058 | CEFACLOR EXTENDED-RELEASE TABLETS, USP 375 MG 500 MG | TEVA PHARMACEUTICALS USA | 9/4/02 |
2 | 75-163 | TIMOLOL MALEATE OPHTHALMIC SOLUTION, USP 0.5% (BASE) | HI-TECH PHARMACAL CO., INC. | 9/10/02 |
3 | 75-893 | FLUVOXAMINE MALEATE TABLETS 25 MG 50 MG 100 MG | TEVA PHARMACEUTICALS USA | 9/10/02 |
4 | 76-350 | POTASSIUM IODIDE TABLETS, USP 65 MG | RECIP, AB | 9/10/02 |
5 | 75-819 | AMANTADINE HYDROCHLORIDE SYRUP, USP 50 MG/5 ML | CAROLINA MEDICAL PRODUCTS COMPANY, INC. | 9/11/02 |
6 | 75-668 | NIZATIDINE CAPSULES, USP 150 MG AND 300 MG | TEVA PHARMACEUTICALS USA | 9/12/02 |
7 | 65-102 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG AND 125 MG (BASE), RESPECTIVELY | RANBAXY LABORATORIES, LTD. | 9/17/02 |
8 | 75-907 | HYDROCHLOROTHIAZIDE CAPSULES 12.5 MG | VINTAGE PHARMACEUTICALS, INC. | 9/17/02 |
9 | 75-804 | NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS 0.25 MG/0.035 MG, RESPECTIVELY, 28-DAY REGIMEN. | BARR LABORATORIES, INC. | 9/25/02 |
10 | 75-519 | RANITIDINE TABLETS, USP (OTC) 75 MG | GENEVA PHARMACEUTICALS, INC. | 9/26/02 |
11 | 75-526 | TICLOPIDINE HYDROCHLORIDE TABLETS 250 MG | CARACO PHARMACEUTICAL LABORATORIES, LTD. | 9/26/02 |
12 | 76-130 | ALBUTEROL EXTENDED-RELEASE TABLETS 4 MG AND 8 MG | SIDMAK LABORATORIES, INC. | 9/26/02 |
13 | 76-140 | SOTALOL HYDROCHLORIDE TABLETS 80 MG, 120 MG, 160 MG, AND 240 MG | TORPHARM | 9/26/02 |
14 | 40-470 | AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) TABLETS 5 MG (TOTAL) | EON LABS, INC. | 9/27/02 |
15 | 76-102 | LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, 30 MG, AND 40 MG |
FDA/Center for Drug Evaluation and Research
Last Updated: October 15, 2002
Originator: OTCOM/OGD
HTML by SJW