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Approvals - March 2002

  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

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Last Updated: April 25, 2006
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