|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
76-608 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG |
ANDRX PHARMACEUTICALS,LLC |
12/3/2004 |
2 |
76-624 |
MOMETASONE FUROATE OINTMENT, USP 0.1% |
TARO PHARMACEUTICALS USA, INC. |
12/3/2004 |
3 |
76-711 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, USP 200 MG |
IMPAX LABORATORIES, INC. |
12/3/2004 |
4 |
77-167 |
DIDANOSINE DELAYED-RELEASE CAPSULES 200
MG, 250 MG, AND 400 MG |
BARR LABORATORIES, INC. |
12/3/2004 |
5 |
77-030 |
CILOSTAZOL TABLETS 50 MG AND 100 MG |
APOTEX , INC. |
12/10/2004 |
6 |
65-171 |
DEMECLOCYCLINE HYDROCHLORIDE TABLETS, USP
150 MG AND 300 MG |
BARR LABORATORIES, INC. |
12/13/2004 |
7 |
76-990 |
FLUOXETINE CAPSULES, USP 40 MG |
RANBAXY LABORATORIES LIMITED |
12/13/2004 |
8 |
77-043 |
CITALOPRAM HYDROBROMIDE ORAL SOLUTION 10
MG (BASE)/ 5 ML |
ROXANE LABORATORIES, INC. |
12/13/2004 |
9 |
76-223 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
SANDOZ INC. |
12/14/2004 |
10 |
76-706 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
APOTEX INC. |
12/14/2004 |
11 |
76-818 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
COBALT PHARMACEUTICALS, INC. |
12/14/2004 |
12 |
76-873 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE
TABLETS 500 MG |
EON LABS, INC. |
12/14/2004 |
13 |
75-827 |
GABAPENTIN TABLETS 600 MG AND 800 MG |
TEVA PHARMACEUTICALS USA |
12/15/2004 |
14 |
76-607 |
QUINAPRIL TABLETS, USP 5 MG, 10 MG, 20
MG, AND 40 MG |
RANBAXY LABORATORIES LIMITED |
12/15/2004 |
15 |
40-569 |
PROPOXYPHENE HYDROCHLORIDE CAPSULES, USP
65 MG |
MYLAN PHARMACEUTICALS, INC. |
12/16/2004 |
16 |
76-831 |
FLAVOXATE HYDROCHLORIDE TABLETS 100 MG |
PADDOCK LABORATORIES, INC. |
12/16/2004 |
17 |
76-872 |
HALOBETASOL PROPIONATE OINTMENT 0.05% |
AGIS INDUSTRIES (1983) LTD. |
12/16/2004 |
18 |
76-903 |
HALOBETASOL PROPIONATE OINTMENT 0.05% |
ALTANA INC. |
12/16/2004 |
19 |
76-922 |
FLUOXETINE CAPSULES, USP 10 MG, 20 MG,
AND 40 MG |
PAR PHARMACEUTICAL, INC. |
12/16/2004 |
20 |
76-994 |
HALOBETASOL PROPIONATE OINTMENT 0.05% |
TARO PHARMACEUTICALS USA, INC. |
12/16/2004 |
21 |
77-001 |
HALOBETASOL PROPIONATE CREAM 0.05% |
ALTANA INC. |
12/16/2004 |
22 |
77-123 |
HALOBETASOL PROPIONATE CREAM 0.05% |
AGIS INDUSTRIES (1983) LTD. |
12/16/2004 |
23 |
65-175 |
NYSTATIN TOPICAL POWDER, USP 100,000
UNITS/GRAM |
X-GEN PHARMACEUTICALS, INC. |
12/17/2004 |
24 |
76-574 |
ECONAZOLE NITRATE CREAM 1% |
HEALTHPOINT, LTD. |
12/17/2004 |
25 |
76-739 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
TABLETS 10 MG/12.5 MG AND 20 MG/12.5 MG |
RANBAXY LABORATORIES LIMITED |
12/17/2004 |
26 |
75-317 |
TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG
(BASE), 2 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) |
TRIGEN LABORATORIES, INC. |
12/20/2004 |
27 |
40-581 |
PREDNISONE TABLETS, USP 2.5 MG |
VINTAGE PHARMACEUTICALS, INC. |
12/21/2004 |
28 |
40-584 |
PREDNISONE TABLETS, USP 1 MG |
VINTAGE PHARMACEUTICALS, INC. |
12/21/2004 |
29 |
76-679 |
MOMETASONE FUROATE CREAM, USP 0.1% |
TARO PHARMACEUTICALS U.S.A., INC. |
12/21/2004 |
30 |
40-568 |
GLYCOPYRROLATE TABLETS, USP 1 MG AND 2 MG
|
COREPHARMA LLC |
12/22/2004 |
31 |
76-459 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG
(BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
AMIDE PHARMACEUTICAL, INC. |
12/22/2004 |
32 |
76-963 |
PILOCARPINE HYDROCHLORIDE TABLETS 5 MG |
ROXANE LABORATORIES, INC. |
12/22/2004 |
33 |
76-694 |
QUINAPRIL HYDROCHLORIDE TABLETS 5 MG
(BASE), 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
MYLAN PHARMACEUTICALS, INC. |
12/23/2004 |
34 |
76-855 |
HYDROMORPHONE HYDROCHLORIDE TABLETS, USP
8 MG |
MALLINCKRODT, INC. |
12/23/2004 |
35 |
76-987 |
FOSINOPRIL SODIUM TABLETS 10 MG, 20 MG
AND 40 MG |
WATSON LABORATORIES, INC. |
12/23/2004 |
36 |
65-139 |
CLINDAMYCIN PHOSPHATE VAGINAL CREAM, USP
2% (BASE) |
ALTANA INC. |
12/27/2004 |
37 |
76-842 |
HYDROCORTISONE BUTYRATE OINTMENT, USP
0.1% |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
12/27/2004 |
38 |
40-600 |
HYDROXYZINE HYDROCHLORIDE TABLETS, USP 10
MG |
AMIDE PHARMACEUTICAL, INC. |
12/28/2004 |
39 |
40-602 |
HYDROXYZINE HYDROCHLORIDE TABLETS, USP 25
MG |
AMIDE PHARMACEUTICAL, INC. |
12/28/2004 |
40 |
40-604 |
HYDROXYZINE HYDROCHLORIDE TABLETS, USP 50
MG |
AMIDE PHARMACEUTICAL, INC. |
12/28/2004 |
41 |
76-682 |
OXYBUTYNIN CHLORIDE SYRUP, USP 5 MG/5 ML
|
VINTAGE PHARMACEUTICALS, LLC |
12/28/2004 |
42 |
76-435 |
CICLOPIROX OLAMINE CREAM, USP 0.77% |
ALTANA INC. |
12/29/2004 |