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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - October 2012

 

Generic Drug Name

Generic Manufacturer

Brand Name

Approval Date

1

GUANFACINE EXTENDED-RELEASE TABLETS, 1 MG, 2 MG, 3 MG AND 4 MG    

ACTAVIS ELIZABETH LLC

INTUNIV EXTENDED-RELEASE TABLETS

10/5/2012 

2

NICOTINE POLACRILEX LOZENGES (MINI LOZENGES) (OTC), 2 MG AND 4 MG (MINT FLAVORED)      

PERRIGO R&D COMPANY

NICORETTE MINI LOZENGES

10/9/2012 

3

TRETINOIN CREAM USP, 0.075%       

PRECISION DERMATOLOGY, INC.

RETIN-A CREAM

10/11/2012 

4

TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES, 60 MG       

WATSON LABORATORIES, INC. - FLORIDA

SANCTURA XR CAPSULES

10/12/2012 

5

ULTRAMICROSIZE GRISEOFULVIN TABLETS USP, 125 MG AND 250 MG      

SIGMAPHARM LABORATORIES, LLC

GRIS-PEG TABLETS

10/22/2012 

6

TRETINOIN CAPSULES, 10 MG       

ANCHEN PHARMACEUTICALS, INC.

VESANOID CAPSULES

10/24/2012