|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-318 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG |
IMPAX LABORATORIES, INC. |
9/4/2003 |
2 |
76-467 |
GLIPIZIDE EXTENDED-RELEASE TABLETS 10 MG |
WATSON LABORATORIES, INC. |
9/8/2003 |
3 |
76-306 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
ROXANE LABORATORIES, INC. |
9/8/2003 |
4 |
76-523 |
MEFLOQUINE HYDROCHLORIDE TABLETS 250 MG |
ROXANE LABORATORIES, INC. |
9/12/2003 |
5 |
76-564 |
ADENOSINE INJECTION, USP 3 MG/ML PACKAGED IN 6 MG/2 ML AND 12 MG/4 ML SINGLE-DOSE VIALS |
SICOR PHARMACEUTICALS, INC. |
9/23/2003 |
6 |
76-583 |
KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION 0.5% |
ALCON INC. |
9/24/2003 |
7 |
76-089 |
CIPROFLOXACIN TABLETS, USP 100 MG, 250 MG, 500 MG, AND 750 MG |
IVAX PHARMACEUTICALS, INC. |
9/25/2003 |
8 |
76-432 |
FLUCONAZOLE TABLETS 50 MG, 100 MG, 150 MG, AND 200 MG |
GEDEON RICHTER LTD. |
9/25/2003 |
9 |
76-285 |
SIMVASTATIN TABLETS, USP 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG |
RANBAXY LABORATORIES, LIMITED |
9/26/2003 |
10 |
76-343 |
TOPIRAMATE TABLETS 25 MG, 100 MG, AND 200 MG |
IVAX PHARMACEUTICALS, INC. |
9/26/2003 |
11 |
76-168 |
OXYCODONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS 80 MG |
TEVA PHARMACEUTICALS USA |
9/29/2003 |
12 |
75-716 |
PAROXETINE HYDROCHLORIDE TABLETS 10 MG, 20 MG, 30 MG, AND 40 MG |
ALPHAPHARM PTY., LTD. |
9/29/2003 |
13 |
76-445 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, 40 MG, AND 80 MG |
RANBAXY LABORATORIES LIMITED |
9/30/2003 |
14 |
76-341 |
PRAVASTATIN SODIUM TABLETS 10 MG, 20 MG, AND 40 MG |
TORPHARM INC. |
9/30/2003 |
15 |
76-342 |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLETS 5 MG/6.25 MG, 10 MG/12.5 MG, 20
MG/12.5 MG, AND 20 MG/25 MG |
ANDRX PHARMACEUTICALS, INC. |
9/30/2003 |