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Tentative Approvals - December 2006
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ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
| 1 |
77-842 |
GRANISETRON HYDROCHLORIDE TABLETS, 1 MG (BASE) |
ROXANE LABORATORIES, INC. |
12/7/2006 |
| 2 |
78-127 |
ONDANSETRON ORAL SOLUTION USP, 4 MG/5 ML |
APOTEX INC. |
12/11/2006 |
| 3 |
77-522 |
TRANDOLAPRIL TABLETS, 1 MG 2 MG 4 MG |
LUPIN PHARMACEUTICALS, INC |
12/12/2006 |
| 4 |
77-415 |
BUPROPION HCL EXTENDED-RELEASE TABLETS USP, 150 MG |
IMPAX LABORATORIES, INC. |
12/15/2006 |
| 5 |
77-512 |
ESCITALOPRAM OXALATE TABLETS, 5 MG (BASE), 10 MG (BASE), AND 20 MG (BASE) |
ACTAVIS ELIZABETH LLC |
12/18/2006 |
| 6 |
77-306 |
ONDANSETRON HYDROCHLORIDE TABLETS, 4 MG (BASE) AND 8 MG (BASE) |
APOTEX INC. |
12/19/2006 |
| 7 |
78-064 |
EFAVIRENZ CAPSULES, 50 MG, 100 MG, AND 200 MG |
AUROBINDO PHARMA LIMITED |
12/19/2006 |
| 8 |
78-026 |
PAROXETINE TABLETS USP, 10 MG, 20 MG, 30 MG, AND 40 MG |
ROXANE LABORATORIES, INC. |
12/19/2006 |
| 9 |
78-032 |
ESCITALOPRAM OXALATE TABLETS, 5 MG (BASE), 10 MG (BASE), AND 20 MG (BASE) |
KALI LABORATORIES, INC. |
12/27/2006 |
| 10 |
77-670 |
SERTRALINE HYDROCHLORIDE TABLETS, 25 MG (BASE), 50 MG (BASE), AND 100 MG (BASE) |
LUPIN LIMITED |
12/28/2006 |
| 11 |
77-410 |
NIFEDIPINE EXTENDED-RELEASE TABLETS USP, 90 MG |
OSMOTICA PHARMACEUTICAL CORP. |
12/28/2006 |
| 12 |
77-107 |
DEXMETHYLPHENIDATE HYDROCHLORIDE TABLETS, 2.5 MG, 5 MG, AND 10 MG |
TEVA PHARMACEUTICALS USA |
12/29/2006 |
| 13 |
76-935 |
MODAFINIL TABLETS, 100 MG AND 200 MG |
SANDOZ INC. |
12/29/2006 |
| 14 |
77-667 |
MODAFINIL TABLETS, 100 MG AND 200 MG |
APOTEX INC. |
12/29/2006 |
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Date created: January 4, 2007 |
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