|
| ANDA Number
| Drug Name
| Applicant
| Approval Date
|
| 1 |
65-066 |
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, U 200 MG/28.5 MG (BASE)/5 ML, AND 400 MG/57 MG (BASE)/5 ML |
GENEVA PHARMACEUTICALS, INC. |
6/5/02 |
| 2 |
75-714 |
CARBAMAZEPINE ORAL SUSPENSION, USP 100 MG/5 ML |
MORTON GROVE PHARMACEUTICALS, INC. |
6/5/02 |
| 3 |
75-991 |
LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG |
CARLSBAD TECHNOLOGY, INC. |
6/5/02 |
| 4 |
76-187 |
LEVOTHYROXINE SODIUM TABLETS, USP 0.025 MG, 0.05 MG, 0.075 MG, 0.088 MG, 0.1 MG, 0.112 MG, 0.125 MG, 0.15 MG, 0.175 MG, 0.2 MG, AND 0.3 MG |
MYLAN PHARMACEUTICALS INC. |
6/5/02 |
| 5 |
76-170 |
LITHIUM CARBONATE EXTENDED-RELEASE TABLETS, USP 300 MG |
BARR LABORATORIES, INC. |
6/10/02 |
| 6 |
75-575 |
AMMONIUM LACTATE LOTION 12% (BASE) |
PADDOCK LABORATORIES, INC. |
6/11/02 |
| 7 |
75-589 |
TRETINOIN GEL, USP 0.01% |
SPEAR PHARMACEUTICALS, INC. |
6/11/02 |
| 8 |
75-856 |
MIDAZOLAM HYDROCHLORIDE INJECTION (PRESERVATIVE-FREE) 1 MG (BASE)/ML AND 5 MG (BASE)/ML PACKAGED IN CARPUJECT SYRINGE |
ABBOTT LABORATORIES |
6/13/02 |
| 9 |
40-439 |
AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 10 MG (TOTAL), 20 MG (TOTAL), AND 30 MG (TOTAL) |
EON LABS, INC. |
6/14/02 |
| 10 |
40-444 |
AMPHETAMINE AND DEXTROAMPHETAMINE (MIXED SALTS) 5 MG (TOTAL), 10 MG (TOTAL), 20 MG (TOTAL), AND 30 MG (TOTAL) |
COREPHARMA LLC |
6/19/02 |
| 11 |
75-960 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
PUREPAC PHARMACEUTICAL CO. |
6/19/02 |
| 12 |
75-964 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
6/19/02 |
| 13 |
75-977 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
TEVA PHARMACEUTICALS USA |
6/19/02 |
| 14 |
76-003 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
COREPHARMA LLC |
6/20/02 |
| 15 |
76-100 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
MUTUAL PHARMACEUTICAL COMPANY |
6/20/02 |
| 16 |
75-986 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
MYLAN PHARMACEUTICALS, INC. |
6/21/02 |
| 17 |
75-962 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
WATSON LABORATORIES, INC. |
6/24/02 |
| 18 |
75-968 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
EON LABS, INC. |
6/25/02 |
| 19 |
75-983 |
TRAMADOL HYDROCHLORIDE TABLETS 50 MG |
MALLINCKRODT INC. |
6/25/02 |
| 20 |
75-525 |
FLUOXETINE ORAL SOLUTION, USP 20 MG/5 ML |
HI-TECH PHARMACAL CO., INC. |
6/27/02 |
| 21 |
75-841 |
PAMIDRONATE DISODIUM INJECTION 3 MG/ML (30 MG/10 ML), 6 MG/ML (60 MG/10 ML), AND 9 MG/ML (90 MG/10 ML) SINGLE-USE VIALS |
FAULDING PHARMACEUTICAL COMPANY |
6/27/02 |
| 22 |
76-243 |
LITHIUM CARBONATE CAPSULES, USP 300 MG |
WEST-WARD PHARMACEUTICAL CORP. |
6/27/02 |
| 23 |
76-257 |
GLYBURIDE TABLETS, USP (NONMICRONIZED) 1.25 MG, 2.5 MG, AND 5 MG |
COREPHARMA LLC |
6/27/02 |
| 24 |
76-280 |
TIZANIDINE HYDROCHLORIDE TABLETS 4 MG (BASE) |
EON LABS, INC. |
6/27/02 |
| 25 |
75-099 |
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 5 MG (BASE)/5 ML |
MORTON GROVE PHARMACEUTICALS, INC. |
6/28/02 |
