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U.S. Department of Health and Human Services

Drugs

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First-Time Generic Drug Approvals - July 2014

 Generic Drug NameGeneric ManufacturerBrand NameTentative Approval DateApproval Date
1DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE CAPSULES 20 MG/10 MG       PAR PHARMACEUTICAL, INC.NUEDEXTA CAPSULES7/29/2014  
2FROVATRIPTAN SUCCINATE TABLETS, 2.5 MG (BASE)       MYLAN PHARMACEUTICALS INC.FROVA TABLETS7/8/2014  
3IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE TABLETS, (OTC) 200 MG/10 MG       PERRIGO R&D COMPANYADVIL CONGESTION RELIEF TABLETS 7/3/2014 
4ROPIVACAINE HYDROCHLORIDE INJECTION USP, 0.5% (5 MG/ML) PACKAGED IN 150 MG/30 ML SINGLE-DOSE VIALS AND 1% (10 MG/ML) PACKAGED IN 200 MG/20 ML SINGLE-DOSE VIALS    NAVINTA LLCNAROPIN INJECTION 7/17/2014