Tentative Approvals -
March 2005
|
ANDA Number |
Generic Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-520 |
FENOFIBRATE TABLETS 54 MG, 107 MG, AND 160 MG |
PAR PHARMACEUTICAL |
3/3/2005 |
2 |
76-575 |
TOPIRAMATE CAPSULES 15 MG AND 25 MG |
TEVA PHARMACEUTICALS USA |
3/9/2005 |
3 |
77-065 |
TERBINAFINE HYDROCHLORIDE TABLETS 250 MG (BASE) |
GEDEON RICHTER LTD. |
3/10/2005 |
4 |
76-799 |
PIOGLITAZONE HYDROCHLORIDE TABLETS 15 MG (BASE), 30 MG (BASE), AND 45 MG (BASE) |
ALPHAPHARM PTY, LTD. |
3/15/2005 |
5 |
76-415 |
OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG |
TEVA PHARMACEUTICALS USA |
3/24/2005 |
6 |
76-846 |
AMLODIPINE BESYLATE TABLETS 2.5 MG (BASE), 5 MG (BASE), AND 10 MG (BASE) |
TEVA PHARMACEUTICALS USA |
3/24/2005 |
7 |
76-866 |
OLANZAPINE TABLETS 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, AND 20 MG |
MYLAN PHARMACEUTICALS INC. |
3/25/2005 |
8 |
76-826 |
LEVOFLOXACIN OPHTHALMIC SOLUTION 0.5% |
HI-TECH PHARMACAL CO., INC. |
3/28/2005 |
9 |
75-959 |
OCTREOTIDE ACETATE INJECTION (MULTIPLE DOSE VIALS) 0.2 MG/ML AND 1.0 MG/ML |
SICOR PHARMACEUTICALS, INC. |
3/28/2005 |
10 |
75-957 |
OCTREOTIDE ACETATE INJECTION 0.05 MG/ML, 0.1 MG/ML, AND 0.5 MG/ML |
SICOR PHARMACEUTICALS, INC. |
3/28/2005 |
11 |
76-904 |
RISPERIDONE ORAL SOLUTION 1 MG/ML |
ROXANE LABORATORIES, INC. |
3/30/2005 |
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Date created:
April 8, 2005 |