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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - August 2011

 

Generic Drug Name

Generic Manufacturer

Brand Name

Approval Date

1

TRANEXAMIC ACID INJECTION, 100 MG/ML; PACKAGED IN 1000 MG/10 ML SINGLE-DOSE VIALS  

PHARMAFORCE INC.

CYKLOKAPRON INJECTION

8/10/2011 

2

GATIFLOXACIN OPHTHALMIC SOLUTION, 0.3%    

APOTEX CORP.

ZYMAR OPHTHALMIC SOLUTION

8/19/2011 

3

KETOCONAZOLE FOAM, 2%          

PERRIGO ISRAEL PHARMACEUTICALS LTD.

EXTINA FOAM, 2%

8/25/2011 

4

CEVIMELINE HYDROCHLORIDE CAPSULES, 30 MG      

APOTEX INC.

EVOXAC CAPSULES, 30 MG

8/25/2011 

5

PRILOCAINE HYDROCHLORIDE WITH EPINEPHRINE INJECTION USP, 4%/1:200,000; PACKAGED IN CARTRIDGES FOR DENTAL USE    

SEPTODONT INC.

CITANEST FORTE DENTAL

8/30/2011