Drugs

First-Time Generic Drug Approvals - July 2013

  Generic Drug Name Generic Manufacturer Brand Name Approval Date
1 RASAGILINE MESYLATE TABLETS, 0.5 MG (BASE) AND 1 MG (BASE)       WATSON LABORATORIES, INC. AZILECT TABLETS 7/1/2013 
2 DECITABINE FOR INJECTION, 50 MG/VIAL; PACKAGED IN SINGLE-USE VIALS       DR. REDDY'S LABORATORIES, LIMITED DACOGEN INJECTION 7/11/2013 
3 REPAGLINIDE TABLETS USP, 1 MG AND 2 MG       CARACO PHARMACEUTICAL LABORATORIES, LTD. PRANDIN TABLETS 7/11/2013 
4 LAMOTRIGINE ORALLY DISINTEGRATING TABLETS, 25 MG, 50 MG, 100 MG AND 200 MG     WATSON LABORATORIES, INC. LAMICTAL ODT 7/15/2013 
5 ACAMPROSATE CALCIUM DELAYED-RELEASE TABLETS, 333 MG        GLENMARK GENERICS LIMITED CAMPRAL TABLETS 7/16/2013 
6 REPAGLINIDE TABLETS USP, 0.5 MG        PADDOCK LABORATORIES, LLC PRANDIN TABLETS 7/17/2013 
7 TRETINOIN GEL USP, (MICROSPHERES) 0.1%        SPEAR PHARMACEUTICALS, INC. RETIN-A MICRO 7/17/2013 
8 TRETINOIN GEL USP, 0.04%        SPEAR PHARMACEUTICALS, INC. RETIN-A MICRO GEL 7/17/2013 
9 FENOFIBRIC ACID DELAYED-RELEASE CAPSULES, 45 MG AND 135 MG       ANCHEN PHARMACEUTICALS, INC. TRILIPIX DELAYED-RELEASE CAPSULES 7/18/2013 
10 METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS USP, 500 MG AND 1000 MG       LUPIN LIMITED GLUMETZA TABLETS 7/19/2013 
11 DONEPEZIL HYDROCHLORIDE TABLETS 23 MG        PAR PHARMACEUTICAL, INC. ARICEPT TABLETS 7/23/2013 

 

 

Page Last Updated: 09/01/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.