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Drug Information

Approvals April 2001

  ANDA Number Drug Name Applicant Approval Date
1 75-547 THIOTEPA FOR INJECTION, USP 15 MG/VIAL BEDFORD LABORATORIES 4/2/01
2 75-498 TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE) 2 MG (BASE) 5 MG (BASE) 10 MG (BASE) TORPHARM 4/12/01
3 75-630 BETAXOLOL OPHTHALMIC SOLUTION, USP 0.5% (5 ML, 10 ML, & 15 ML) BAUSCH & LOMB PHARMACEUTICALS, INC. 4/12/01
4 75-842 OXAPROZIN TABLETS 600 MG INVAMED, INC. 4/12/01
5 75-062 FAMOTIDINE TABLETS, USP 20 MG 40 MG DANBURY PHARMACAL, INC. 4/16/01
6 75-302 FAMOTIDINE TABLETS, USP 20 MG 40 MG GENEVA PHARMACEUTICALS, INC. 4/16/01
7 75-311 FAMOTIDINE TABLETS, USP 20 MG 40 MG TEVA PHARMACEUTICALS USA 4/16/01
8 75-486 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS ESI LEDERLE 4/16/01
9 75-488 FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) ESI LEDERLE 4/16/01
10 75-511 FAMOTIDINE TABLETS, USP 20 MG 40 MG ZENITH GOLDLINE PHARMACEUTICALS, INC. 4/16/01
11 75-622 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML VIALS) BEDFORD LABORATORIES 4/16/01
12 75-651 FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) BEDFORD LABORATORIES 4/16/01
13 75-669 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS FAULDING PHARMACEUTICAL COMPANY 4/16/01
14 75-684 FAMOTIDINE INJECTION 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGE BEDFORD LABORATORIES 4/16/01
15 75-704 FAMOTIDINE TABLETS, USP 20 MG 40 MG MYLAN PHARMACEUTICALS, INC. 4/16/01
16 75-705 FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) FAULDING PHARMACEUTICAL COMPANY 4/16/01
17 75-707 FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) APOTHECON INC. 4/16/01
18 75-708 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS APOTHECON INC. 4/16/01
19 75-709 FAMOTIDINE INJECTION 10 MG/ML (MULTIPLE-DOSE VIALS) AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/16/01
20 75-718 FAMOTIDINE TABLETS, USP 20 MG 40 MG DR. REDDY'S LABORATORIES LIMITED 4/16/01
21 75-786 FAMOTIDINE TABLETS, USP 20 MG 40 MG WOCKHARDT AMERICAS, INC. 4/16/01
22 75-793 FAMOTIDINE TABLETS, USP 20 MG 40 MG EON LABS MANUFACTURING, INC. 4/16/01
23 75-805 FAMOTIDINE TABLETS, USP 20 MG 40 MG CARLSBAD TECHNOLOGY, INC. 4/16/01
24 75-813 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (20 MG/2 ML) VIALS AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/16/01
25 74-567 IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLETS, USP 200 MG/30 MG OHM LABORATORIES, INC. 4/17/01
26 75-825 FAMOTIDINE INJECTION (PRESERVATIVE-FREE) 10 MG/ML (500 MG/50 ML) PHARMACY BULK PACKAGE BEN VENUE LABORATORIES, INC. 4/17/01
27 75-457 FAMOTIDINE TABLETS, USP 20 MG 40 MG GENPHARM INC. 4/18/01
28 75-894 FLUVOXAMINE MALEATE TABLETS 25 MG, 50 MG, AND 100 MG WATSON LABORATORIES, INC. 4/18/01
29 75-390 NAPROXEN DELAYED RELEASE TABLETS 375 MG 500 MG ALPHAPHARM PTY. LTD. 4/19/01
30 75-730 THIOTEPA FOR INJECTION, USP 15 MG/VIAL 30 MG/VIAL GENSIA SICOR PHARMACEUTICALS, INC. 4/20/01
31 75-906 PROGESTERONE INJECTION, USP 50 MG/ML (MULTIPLE-DOSE VIAL) AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/25/01
32 75-811 MESNA INJECTION 100 MG/ML; (10 ML MULTIPLE-DOSE VIAL) AMERICAN PHARMACEUTICAL PARTNERS, INC. 4/26/01
33 75-058 FLURBIPROFEN TABLETS, USP 50 MG 100 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 4/27/01
34 75-423 CLONAZEPAM TABLETS, USP 0.5 MG, 1 MG, AND 2 MG CARACO PHARMACEUTICAL LABORATORIES, LTD. 4/27/01
35 75-500 SOTALOL HYDROCHLORIDE TABLETS 80 MG 120 MG 160 MG 240 MG UPSHER-SMITH LABORATORIES, INC. 4/27/01
36 75-764 MESNA INJECTION 100 MG/ML (10 ML MULTIPLE-DOSE VIAL) GENSIA SICOR PHARMACEUTICALS, INC. 4/27/01
37 75-850 OXAPROZIN TABLETS 600 MG GENEVA PHARMACEUTICALS, INC. 4/27/01
38 75-290 PAMIDRONATE DISODIUM FOR INJECTION 30 MG/VIAL, AND 90 MG/VIAL BEDFORD LABORATORIES 4/30/01
39 75-796 LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.1 MG/0.02 MG, RESPECTIVELY; (21-DAY AND 28-DAY CYCLES) DURAMED PHARMACEUTICALS, INC. 4/30/01

 

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