|
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 |