Drugs

First-Time Generic Drug Approvals - March 2013

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

 

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