|
ANDA Number |
Generic Drug Name |
Applicant |
Approval Date |
1 |
77-052 |
CITALOPRAM HYDROBROMIDE TABLETS, 10 MG (BASE), 20 MG (BASE), AND 40 MG (BASE) |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
7/3/2006 |
2 |
40-616 |
WARFARIN SODIUM TABLETS USP, 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MG |
PLIVA INC. |
7/5/2006 |
3 |
65-246 |
AZITHROMYCIN FOR ORAL SUSPENSION USP, 100 MG/5 ML AND 200 MG/5 ML |
PLIVA, INC. |
7/5/2006 |
4 |
76-232 |
AMIODARONE HYDROCHLORIDE INJECTION, 50 MG/ML; 3 ML AMPULES |
AKORN INC. |
7/5/2006 |
5 |
76-945 |
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, 10 MG/12.5 MG AND 20 MG/12.5 MG |
TEVA PHARMACEUTICALS USA |
7/5/2006 |
6 |
76-877 |
GABAPENTIN TABLETS, 600 MG AND 800 MG |
SANDOZ INC. |
7/6/2006 |
7 |
65-326 |
CEPHALEXIN FOR ORAL SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML |
ORCHID HEALTHCARE |
7/10/2006 |
8 |
77-820 |
GLIPIZIDE TABLETS USP, 5 MG AND 10 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
7/11/2006 |
9 |
76-850 |
TERCONAZOLE VAGINAL SUPPOSITORIES, 80 MG |
ALTANA INC. |
7/12/2006 |
10 |
77-547 |
METRONIDAZOLE TOPICAL GEL USP, 0.75% |
QLT USA, INC. |
7/13/2006 |
11 |
40-622 |
PROMETHAZINE HYDROCHLORIDE TABLETS USP, 12.5 MG, 25 MG, AND 50 MG |
VINTAGE PHARMACEUTICALS, LLC |
7/18/2006 |
12 |
77-819 |
METRONIDAZOLE TOPICAL GEL USP, 0.75% |
TARO PHARMACEUTICAL INDUSTRIES LTD. |
7/18/2006 |
13 |
77-920 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
BRECKENRIDGE PHARMACEUTICAL, INC. |
7/19/2006 |
14 |
77-921 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
7/19/2006 |
15 |
77-923 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
MYLAN PHARMACEUTICALS, INC. |
7/19/2006 |
16 |
77-925 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
ROXANE LABORATORIES, INC. |
7/19/2006 |
17 |
77-929 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
WATSON LABORATORIES, INC. |
7/19/2006 |
18 |
77-930 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
COREPHARMA LLC |
7/19/2006 |
19 |
77-932 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
GLENMARK PHARMACEUTICALS LTD. |
7/19/2006 |
20 |
77-933 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
PAR PHARMACEUTICAL |
7/19/2006 |
21 |
77-935 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
7/19/2006 |
22 |
77-936 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
TEVA PHARMACEUTICALS, USA |
7/19/2006 |
23 |
77-937 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
CARACO PHARMACEUTICAL LABORATORIES, LTD. |
7/19/2006 |
24 |
77-938 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
ACTAVIS TOTOWA LLC |
7/19/2006 |
25 |
77-944 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
LUPIN LIMITED |
7/19/2006 |
26 |
77-882 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
APOTEX INC. |
7/20/2006 |
27 |
77-934 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
GENPHARM INC. |
7/20/2006 |
28 |
65-240 |
AMPICILLIN AND SULBACTAM FOR INJECTION USP, 10 G(BASE) AND 5 G(BASE), RESPECTIVELY, (PHARMACY BULK PACKAGE) |
SANDOZ INC. |
7/25/2006 |
29 |
65-241 |
AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1.5 G AND 3 MG; PACKAGED IN VIALS |
SANDOZ INC. |
7/25/2006 |
30 |
65-310 |
AMPICILLIN AND SULBACTAM FOR INJECTION USP, 1.5 G AND 3 G; PACKAGED IN ADD-VANTAGE VIALS |
SANDOZ INC. |
7/25/2006 |
31 |
65-320 |
ERYTHROMYCIN PLEDGETS USP, 2% |
ALTANA INC. |
7/25/2006 |
32 |
77-931 |
MELOXICAM TABLETS, 7.5 MG AND 15 MG |
DR. REDDY'S LABORATORIES LIMITED |
7/25/2006 |
33 |
76-756 |
METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 500 MG |
SYNOVICS LABORATORIES, INC. |
7/26/2006 |
34 |
76-914 |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, 37.5 MG/325 MG |
BARR LABORATORIES, INC. |
7/26/2006 |
35 |
40-667 |
PRIMIDONE TABLETS USP, 50 MG AND 250 MG |
WEST-WARD PHARMACEUTICAL CORP. |
7/27/2006 |
36 |
77-836 |
GEMFIBROZIL TABLETS USP, 600 MG |
INVAGEN PHARMACEUTICALS, INC. |
7/27/2006 |
37 |
77-895 |
URSODIOL CAPSULES USP, 300 MG |
COREPHARMA LLC |
7/27/2006 |
38 |
65-220 |
NEOMYCIN SULFATE TABLETS USP, 500 MG [350 MG (BASE)] |
X-GEN PHARMACEUTICALS, INC. |
7/28/2006 |
39 |
76-436 |
FINASTERIDE TABLETS USP, 1 MG |
DR. REDDY'S LABORATORIES LIMITED |
7/28/2006 |
40 |
77-853 |
METFORMIN HYDROCHLORIDE TABLETS USP, 500 MG, 850 MG, AND 1000 MG |
AMNEAL PHARMACEUTICALS LLC |
7/28/2006 |
41 |
40-712 |
PROMETHAZINE HYDROCHLORIDE TABLETS USP, 25 MG |
KVK-TECH, INC. |
7/31/2006 |
42 |
40-713 |
PROMETHAZINE HYDROCHLORIDE TABLETS USP, 50 MG |
KVK-TECH, INC. |
7/31/2006 |
43 |
76-969 |
METOPROLOL SUCCINATE EXTENDED-RELEASE TABLETS, USP 25 MG |
SANDOZ INC. |
7/31/2006 |
44 |
77-725 |
ALPRAZOLAM EXTENDED-RELEASE TABLETS 0.5 MG, 1 MG, 2 MG, AND 3 MG |
BARR LABORATORIES, INC. |
7/31/2006 |