|
| 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 |
|
|
