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Tentative Approvals - July 2006
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-112 |
ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE), 8 MG (BASE), AND 24 MG (BASE) |
PLIVA HRVATSKA D.O.O. |
7/5/2006 |
| 2 |
77-275 |
DIDANOSINE TABELTS, 100 MG, 150 MG, AND 200 MG |
AUROBINDO PHARMA LIMITED INC. |
7/10/2006 |
| 3 |
77-375 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, 2.5 MG(BASE)/10 MG, 5 MG(BASE)/10 MG, 5 MG(BASE)/20 MG, AND 10 MG(BASE)/20 MG |
MYLAN PHARMACEUTICALS, INC. |
7/11/2006 |
| 4 |
77-179 |
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, 2.5 MG(BASE)/10 MG, 5 MG(BASE)/10 MG, 5 MG (BASE)/20 MG, AND 10 MG (BASE)/20 MG |
TEVA PHARMACEUTICALS, USA |
7/11/2006 |
| 5 |
77-469 |
FLUOXETINE CAPSULES USP, 10 MG AND 20 MG |
SANDOZ INC. |
7/14/2006 |
| 6 |
77-818 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
7/14/2006 |
| 7 |
77-557 |
ONDANSETRON ORALLY DISINTEGRATING TABLETS, 4 MG AND 8 MG |
SUN PHARMACEUTICAL INDUSTRIES LTD. |
7/17/2006 |
| 8 |
77-288 |
ZOLPIDEM TARTRATE TABLETS, 5 MG AND 10 MG |
MUTUAL PHARMACEUTICAL COMPANY, INC. |
7/17/2006 |
| 9 |
77-412 |
ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MG |
TEVA PHARMACEUTICALS USA |
7/26/2006 |
| 10 |
77-238 |
ZALEPLON CAPSULES, 5 MG AND 10 MG |
GENPHARM INC. |
7/26/2006 |
| 11 |
77-533 |
TERBINAFINE HYDROCHLORIDE TABLETS, 250 MG (BASE) |
INVAGEN PHARMACEUTICALS, INC. |
7/28/2006 |
| 12 |
76-969 |
METOPROLOL SUCCINATE EXTENDED- RELEASE TABLETS, USP 50 MG, 100 MG, AND 200 MG |
SANDOZ INC. |
7/31/2006 |
| 13 |
77-582 |
ONDANSETRON INJECTION USP, 2 MG/ML, PACKAGED IN 40 MG/20 ML MULTIPLE-DOSE VIALS |
PHARMAFORCE, INC. |
7/31/2006 |
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Date created: August 3, 2006 |
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