Tentative Approvals - January 2002
|
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
1 |
76-007 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG |
RANBAXY LABORATORIES LIMITED |
1/4/02 |
2 |
76-113 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG |
MYLAN PHARMACEUTICALS, INC. |
1/7/02 |
3 |
76-119 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
TEVA PHARMACEUTICALS USA |
1/15/02 |
4 |
76-122 |
MIRTAZAPINE TABLETS 15 MG, 30 MG, AND 45 MG |
MYLAN PHARMACEUTICALS, INC. |
1/15/02 |
5 |
75-250 |
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION 15 MG (BASE)/5 ML |
WE PHARMACEUTICALS, INC. |
1/17/02 |
6 |
76-180 |
LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, AND 10 MG |
PUREPAC PHARMACEUTICAL CO. |
1/18/02 |
7 |
75-932 |
BUPROPION HYDROCHLORIDE EXTENDED-RELEASE TABLETS 100 MG, AND 150 MG |
EON LABS MANUFACTURING, INC. |
1/24/02 |
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