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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - February 2013

 Generic Drug NameGeneric ManufacturerBrand NameApproval Date
1DOXORUBICIN HYDROCHLORIDE LIPOSOME INJECTION USP, 2 MG/ML; PACKAGED IN 20 MG/10 ML AND 50 MG/25 ML SINGLE-USE VIALS    SUN PHARMA GLOBAL FZEDOXIL LIPOSOME INJECTION2/4/2013 
2MAFENIDE ACETATE, USP FOR 5% TOPICAL SOLUTION, 50 G STERILE POWDER PER PACKET       PAR FORMULATIONS PRIVATE LIMITEDSULFAMYLON FOR 5% TOPICAL SOLUTION2/12/2013 
3FLUDEOXYGLUCOSE F 18 INJECTION USP, 20-500 mCi/mL @ EOS       HOUSTON CYCLOTRON PARTNERS LPFLUDEOXYGLUCOSE F18 INJECTION, USP2/14/2013 
4BUPRENORPHINE HCl AND NALOXONE HCl DIHYDRATE SUBLINGUAL TABLETS, 2 MG (BASE)/0.5 MG (BASE) AND 8 MG (BASE)/2 MG (BASE)     AMNEAL PHARMACEUTICALSSUBOXONE SUBLINGUAL TABLETS2/22/2013 
5BUPRENORPHINE HCl AND NALOXONE HCL DIHYDRATE SUBLINGUAL TABLETS, 2 MG (BASE)/0.5 MG (BASE) AND 8 MG (BASE)/2 MG (BASE)     ACTAVIS ELIZABETH LLCSUBOXONE TABLETS (SUBLINGUAL)2/22/2013 
6ALENDRONATE SODIUM ORAL SOLUTION, 70 MG (BASE)/75 ML (ONCE WEEKLY)      ROXANE LABORATORIES, INC.FOSAMAX ORAL SOLUTION2/25/2013 
7DEXBROMPHENIRAMINE MALEATE & PSEUDOEPHEDRINE SULFATE EXTENDED-RELEASE TABLETS, (OTC), 6 MG/120 MG      AVANTHI INC.DRIXORAL COLD AND ALLERGY TABLETS2/27/2013