Tentative Approvals - October 2001
|
ANDA Number |
Drug Name |
Applicant |
Tentative Approval Date |
1 |
75-944 |
LISINOPRIL TABLETS, USP 2.5 MG, 5 MG, 10 MG, 20 MG, AND 40 MG |
RANBAXY LABORATORIES LIMITED |
10/9/01 |
2 |
75-674 |
FAMOTIDINE TABLETS, USP (OTC) 10 MG |
GENPHARM INC. |
10/12/01 |
3 |
76-001 |
FLUOXETINE CAPSULES, USP 10 MG AND 20 MG |
SIDMAK LABORATORIES, INC. |
10/16/01 |
4 |
75-926 |
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS 10 MG/12.5 MG, 20 MG/12.5 MG, AND 20 MG/25 MG |
GENEVA PHARMACEUTICALS TECHNOLOGY CORP. |
10/17/01 |
5 |
75-936 |
MILRINONE LACTATE INJECTION 1 MG (BASE)/ML; 10 MG(BASE)/10 ML, 20 MG (BASE)/20 ML, AND 50 MG (BASE)/50 ML SINGLE-UNIT VIALS |
AMERICAN PHARMACEUTICAL PARTNERS, INC. |
10/17/01 |
6 |
75-834 |
MILRINONE LACTATE IN 5% DEXTROSE INJECTION 0.2 MG (BASE)/ML; PACKAGED IN 20 MG/100 ML AND 40 MG/200 ML PLASTIC CONTAINERS |
BAXTER HEALTHCARE CORPORATION |
10/30/01 |
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