| |
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
76-692 |
AMLODIPINE BESYLATE TABLETS, 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) |
DR. REDDY'S LABORATORIES, LTD. |
4/3/2006 |
| 2 |
77-513 |
RAMIPRIL CAPSULES 1.25 MG 2.5 MG 5 MG 10 MG |
PUREPAC PHARMACEUTICAL CO. |
4/10/2006 |
| 3 |
77-081 |
FEXOFENADINE HYDROCHLORIDE TABLETS 30 MG 60 MG 180 MG |
MYLAN PHARMACEUTICALS, INC. |
4/11/2006 |
| 4 |
77-729 |
ONDANSETRON HYDROCHLORIDE TABLETS 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE) |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
4/14/2006 |
| 5 |
77-387 |
ONDANSETRON INJECTION USP, (PRESERVATIVE-FREE) 2 MG/ML; PACKAGED IN 4 MG/2 ML SINGLE-DOSE VIALS. |
PHARMAFORCE, INC. |
4/14/2006 |
| 6 |
77-578 |
FINASTERIDE TABLETS USP, 5 MG |
MYLAN PHARMACEUTICALS, INC. |
4/14/2006 |
| 7 |
77-691 |
SIMVASTATIN TABLETS USP, 5 MG, 10 MG, 20 MG, 40 MG, AND 80 MG |
AUROBINDO PHARMA LIMITED |
4/19/2006 |
| 8 |
77-057 |
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 20 MG (BASE) AND 40 MG (BASE) |
SANDOZ INC. |
4/19/2006 |
| 9 |
77-056 |
PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS 20 MG (BASE) AND 40 MG (BASE) |
TEVA PHARMACEUTICALS USA |
4/19/2006 |
| 10 |
77-652 |
LEVOFLOXACIN TABLETS 250 MG, 500 MG, AND 750 MG |
ZYDUS PHARMACEUTICALS USA, INC. |
4/20/2006 |
| 11 |
76-287 |
FLUOXETINE CAPSULES USP, 10 MG AND 20 MG (RLD = SARAFEM CAPSULES/LILLY) |
TEVA PHARMACEUTICALS USA |
4/20/2006 |
| 12 |
77-780 |
CARVEDILOL TABLETS 2.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
TARO PHARMACEUTICAL INDUSTRIES, LTD. |
4/21/2006 |
| 13 |
76-311 |
TOPIRAMATE TABLETS 50 MG |
PAR PHARMACEUTICAL |
4/24/2006 |
| 14 |
76-341 |
PRAVASTATIN SODIUM TABLETS 80 MG |
APOTEX INC. |
4/25/2006 |
| 15 |
77-245 |
CIPROFLOXACIN INJECTION USP, 200 MG/20 ML AND 400 MG/40 ML SINGLE-USE VIALS |
HOSPIRA INC. |
4/27/2006 |
