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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - March 2013

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1TRAVOPROST OPHTHALMIC SOLUTION USP, 0.004%       PAR PHARMACEUTICAL, INC.TRAVATAN OPHTHALMIC SOLUTION3/1/2013 
2ZOLEDRONIC ACID INJECTION, 4 MG (BASE)/5 ML; PACKAGED IN SINGLE-DOSE VIALS      PHARMACEUTICS INTERNATIONAL, INC.ZOMETA INJECTION3/4/2013 
3ZOLEDRONIC ACID FOR INJECTION (LYOPHILIZED), 4 MG (BASE)/SINGLE-DOSE VIAL       SUN PHARMA GLOBAL FZEZOMETA FOR INJECTION (LYOPHILIZED)3/4/2013 
4ZOLEDRONIC ACID INJECTION, 4 MG (BASE)/5 ML SINGLE-DOSE VIAL      SUN PHARMA GLOBAL FZEZOMETA INJECTION3/4/2013 
5ZOLEDRONIC ACID INJECTION, 4 MG (BASE)/5 ML; PACKAGED IN SINGLE-USE VIALS      ACTAVIS LLCZOMETA INJECTION3/4/2013 
6ZOLEDRONIC ACID INJECTION, 4 MG (BASE)/5 ML; PACKAGED IN SINGLE-DOSE VIALS      DR. REDDY'S LABORATORIES LIMITEDZOMETA INJECTION3/4/2013 
7ZOLEDRONIC ACID INJECTION, 4 MG (BASE)/5 ML; PACKASGED IN SINGLE-DOSE VIALS      AGILA SPECIALTIES PRIVATE LIMITEDZOMETA INJECTION3/4/2013 
8FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES, 100 MG AND 150 MG      ANCHEN PHARMACEUTICALS, INC.LUVOX CR CAPSULES3/13/2013 
9ESOMEPRAZOLE SODIUM FOR INJECTION, 20 MG AND 40 MG; PACKAGED IN SINGLE-USE VIALS     SUN PHARMA GLOBAL FZENEXIUM I.V. FOR INJECTION3/18/2013 
10MECAMYLAMINE HYDROCHLORIDE TABLETS USP, 2.5 MG       NEXGEN PHARMA, INC.INVERSINE TABLETS3/19/2013 
11SODIUM PHENYLBUTYRATE POWDER, 3 GRAMS/TEASPOONFUL; PACKAGED IN 250 GRAMS/BOTTLE      SIGNAPHARM LABORATORIES, LLCBUPHENYL POWDER3/22/2013 
12FENOFIBRIC ACID DELAYED-RELEASE CAPSULES, 45 MG AND 135 MG      MYLAN PHARMACEUTICALS, INC.TRILIPIX DELAYED-RELEASE CAPSULES3/25/2013 
13AMLODIPINE AND VALSARTAN TABLETS, 5 MG/160 MG, 10 MG/160 MG AND 10 MG/320 MG     PAR PHARMACEUTICAL, INC.EXFORGE TABLETS3/28/2013 
14AMLODIPINE AND VALSARTAN TABLETS, 5 MG/320 MG       PAR PHARMACEUTICAL, INC.EXFORGE TABLETS3/28/2013 
15ZOLEDRONIC ACID INJECTION, 5 MG (BASE)/100 ML (0.05 MG (BASE)/ML); PACKAGED IN 100 ML SINGLE-USE VIALS FOR INTRAVENOUS INFUSION    EMCURE PHARMACEUTICALS LTD.RECLAST INJECTION3/29/2013 
16ZOLEDRONIC ACID INJECTION, 5 MG (BASE)/100 ML (0.05 MG (BASE)/ML); PACKAGED IN SINGLE-USE VIALS FOR INTRAVENOUS ADMINISTRATION    DR. REDDY'S LABORATORIES LIMITEDRECLAST INJECTION3/29/2013