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Tentative Approvals - February 2006
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-210 |
PIOGLITAZONE HYDROCHLORIDE TABLETS, 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE) |
TEVA PHARMACEUTICALS USA |
2/7/2006 |
| 2 |
77-425 |
ADENOSINE INJECTION USP, 3 MG/ML; 20 ML AND 30 ML VIALS |
SICOR PHARMACEUTICALS, INC. |
2/10/2006 |
| 3 |
75-576 |
OMEPRAZOLE DELAYED-RELEASE CAPSULES USP, 10 MG AND 20 MG |
DR. REDDY'S LABORATORIES LIMITED |
2/13/2006 |
| 4 |
76-893 |
DONEPEZIL HYDROCHLORIDE TABLETS, 5 MG AND 10 MG |
PAR PHARMACEUTICAL, INC. |
2/13/2006 |
| 5 |
77-481 |
FOSPHENYTOIN SODIUM INJECTION USP, 75 MG/ML (50 MG PE/ML); 100 MG PE/2 ML AND 500 MG PE/10 ML VIALS [PE=PHENYTOIN SODIUM EQUIVALENTS] |
BEDFORD LABORATORIES |
2/14/2006 |
| 6 |
76-882 |
RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS, 20 MG |
TEVA PHARMACEUTICALS USA |
2/15/2006 |
| 7 |
77-316 |
CARVEDILOL TABLETS, 3.125 MG, 6.25 MG, 12.5 MG, AND 25 MG |
MYLAN PHARMACEUTICALS, INC. |
2/22/2006 |
| 8 |
77-106 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
ZYDUS PHARMACEUTICALS USA, INC. |
2/24/2006 |
| 9 |
76-759 |
ONDANSETRON INJECTION USP, 2 MG/ML; 2 ML VIALS |
TEVA PHARMACEUTICALS USA |
2/24/2006 |
| 10 |
76-876 |
ONDANSETRON INJECTION USP, 2 MG/ML; 20 ML VIALS |
TEVA PHARMACEUTICALS USA |
2/24/2006 |
| 11 |
76-797 |
RISPERIDONE ORAL SOLUTION, 1 MG/ML |
PAR PHARMACEUTICAL, INC. |
2/24/2006 |
| 12 |
77-303 |
ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), 16 MG (BASE), AND 24 MG (BASE) |
KALI LABORATORIES, INC. |
2/27/2006 |
| 13 |
76-252 |
ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE) |
TEVA PHARMACEUTICALS USA |
2/28/2006 |
| 14 |
76-810 |
ONDANSETRON ORALLY DISINTEGRATING TABLETS, 4 MG AND 8 MG |
TEVA PHARMACEUTICALS USA |
2/28/2006 |
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Date created: March 2, 2006 |
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