|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
75-681 |
MEGESTROL ACETATE ORAL SUSPENSION, USP 40 MG/ML |
COPLEY PHARMACEUTICAL, INC. |
5/5/2003 |
2 |
76-353 |
DEXTROAMPHETAMINE SULFATE EXTENDED-RELEASE CAPSULES 5
MG, 10 MG, AND 15 MG |
MALLINCKRODT INC. |
5/6/2003 |
3 |
40-456 |
AMPHETAMINE AND DEXTROAMPHETAMINE TABLETS (MIXED SALTS)
5 MG, 10 MG, 20 MG, AND 30 MG |
WATSON LABORATORIES, INC. |
5/6/2003 |
4 |
76-204 |
MOEXIPRIL HYDROCHLORIDE TABLETS 7.5 MG AND 15 MG |
TEVA PHARMACEUTICALS USA |
5/8/2003 |
5 |
76-224 |
FLUTAMIDE CAPSULES, USP 125 MG |
GENPHARM INC. |
5/9/2003 |
6 |
75-276 |
BETAMETHASONE DIPROPIONATE GEL 0.05% (BASE) |
ALTANA INC. |
5/13/2003 |
7 |
76-065 |
AMCINONIDE CREAM, USP 0.1% |
ALTANA INC. |
5/15/2003 |
8 |
40-490 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
7.5 MG/500 MG |
ABLE LABORATORIES, INC. |
5/21/2003 |
9 |
76-226 |
TORSEMIDE TABLETS 5 MG, 10 MG, 20 MG, AND 100 MG |
PAR PHARMACEUTICAL, INC. |
5/27/2003 |
10 |
40-494 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
7.5 MG/750 MG |
ANDRX PHARMACEUTICALS, LLC |
5/28/2003 |
11 |
40-495 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
10 MG/660 MG |
ANDRX PHARMACEUTICALS, LLC |
5/28/2003 |
12 |
76-260 |
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION 0.2% |
BAUSCH & LOMB PHARMACEUTICALS, INC. |
5/28/2003 |
13 |
40-493 |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 5
MG/500 MG |
ANDRX PHARMACEUTICALS, LLC |
5/28/2003 |
14 |
75-876 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES 10 MG, AND 20 MG |
MYLAN PHARMACEUTICALS, INC. |
5/29/2003 |
15 |
75-504 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG, 10 MG, 20 MG, AND
40 MG |
TEVA PHARMACEUTICALS USA |
5/30/2003 |
16 |
40-405 |
PROCHLORPERAZINE EDISYLATE INJECTION, USP 5 MG
(BASE)/ML PACKAGED IN 10 MG (BASE)'2 ML VIALS AND 50 MG (BASE)/10 ML
MULTIPLE DOSE VIALS |
GENSIA SICOR PHARMACEUTICALS, INC. |
5/30/2003 |
17 |
76-381 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS,
USP 1.5 MG/0.03 MG (21-DAY CYCLE) |
BARR LABORATORIES, INC. |
5/30/2003 |
18 |
76-380 |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS,
USP 1 MG/0.02 MG (21-DAY CYCLE) |
BARR LABORATORIES, INC. |
5/30/2003 |
19 |
76-346 |
TORSEMIDE TABLETS 5 MG, 10 MG, AND 20 MG |
PLIVA PHARMACEUTICAL INDUSTRY, INC. |
5/30/2003 |