Drug Information |
ANDA Number | Drug Name | Applicant | Approval Date | |
1 | 75-385 | BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG, 10 MG, AND 15 MG | ZENITH GOLDLINE PHARMACEUTICALS, INC. | 3/1/02 |
2 | 75-610 | FAMOTIDINE TABLETS, USP (OTC) 10 MG | TORPHARM | 3/12/02 |
3 | 75-824 | BUTORPHANOL TARTRATE NASAL SPRAY 10 MG/ML (1 MG/SPRAY), METERED-DOSE SPRAY PUMP | ROXANE LABORATORIES, INC. | 3/12/02 |
4 | 65-063 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 875 MG AND 125 MG (BASE), RESPECTIVELY | GENEVA PHARMACEUTICALS, INC. | 3/14/02 |
5 | 75-119 | BUSPIRONE HYDROCHLORIDE TABLETS, USP 5 MG AND 10 MG | EGIS PHARMACEUTICALS, LTD. | 3/14/02 |
6 | 75-995 | IBUPROFEN TABLETS 200 MG | L. PERRIGO COMPANY | 3/14/02 |
7 | 65-064 | AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP 500 MG AND 125 MG (BASE), RESPECTIVELY | GENEVA PHARMACEUTICALS, INC. | 3/15/02 |
8 | 75-737 | MINOXIDIL TOPICAL SOLUTION, USP (FOR MEN) 5% | CLAY-PARK LABS, INC. | 3/15/02 |
9 | 76-058 | MIDAZOLAM HYDROCHLORIDE SYRUP 2 MG (BASE)/ML | RANBAXY LABORATORIES, LIMITED | 3/15/02 |
10 | 40-431 | FLUDROCORTISONE ACETATE TABLETS, USP 0.1 MG | IMPAX LABORATORIES | 3/18/02 |
11 | 65-009 | ERYTHROMYCIN TOPICAL GEL, USP 2% | GLADES PHARMACEUTICALS, INC. | 3/18/02 |
12 | 76-067 | MOMETASONE FUROATE OINTMENT, USP 0.1% | CLAY-PARK LABS, INC. | 3/18/02 |
13 | 65-074 | AMPICILLIN AND SULBACTAM FOR INJECTION, USP 1.5 G [1 G (BASE)/500 MG (BASE)], AND 3 G [2 G (BASE)/1 G (BASE)] | ESI LEDERLE | 3/19/02 |
14 | 65-076 | AMPICILLIN AND SULBACTAM FOR INJECTION, USP 10 G (BASE)/5 G (BASE) SUPPLIED AS A 15 G PHARMACY BULK PACKAGE | ESI LEDERLE | 3/19/02 |
15 | 75-413 | BUSPIRONE TABLETS, USP 5 MG, 10 MG, AND 15 MG | GENEVA PHARMACEUTICALS, INC. | 3/19/02 |
16 | 75-860 | DESONIDE LOTION 0.05% | ALTANA INC. | 3/19/02 |
17 | 76-200 | ACETAMINOPHEN EXTENDED-RELEASE TABLETS (OTC) 650 MG | COREPHARMA LLC | 3/19/02 |
18 | 75-803 | LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG (21- AND 28-DAY CYCLES) | BARR LABORATORIES, INC. | 3/20/02 |
19 | 76-264 | NALTREXONE HYDROCHLORIDE TABLETS, USP 25 MG, 50 MG, AND 100 MG | MALLINCKRODT INC. | 3/22/02 |
20 | 76-153 | PAMIDRONATE DISODIUM INJECTION 3 MG/ML 9 MG/ML | GENSIA SICOR PHARMACEUTICALS, INC. | 3/27/02 |
21 | 40-398 | HYDROCORTISONE ACETATE CREAM, USP 2% | FERNDALE LABORATORIES, INC. | 3/29/02 |
22 | 40-412 | HYDROCHLOROTHIAZIDE TABLETS, USP 25 MG, AND 50 MG | VINTAGE PHARMACEUTICALS, INC. | 3/29/02 |
FDA/Center for Drug Evaluation and Research
Last Updated: April 25, 2006
Originator: OGC
HTML by PKS, TA