Drug Information |
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 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
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