USFDA: New and Generic Drug Approvals: 22 SEP 2014

New and Generic Drug Approvals

September 22, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Benzaclinbenzoyl peroxide; clindamycin phosphateGel;TopicalValeant BermudaManufacturing Change or Addition
Bloxiverzneostigmine methylsulfateSolution;IntravenousEclat Pharms LlcManufacturing Change or Addition
Brevital Sodiummethohexital sodiumInjectable;InjectionPar Sterile ProductsManufacturing Change or Addition
Clindesseclindamycin phosphateCream;VaginalLumara Health IncManufacturing Change or Addition
Dorzolamide Hydrochloride and Timolol Maleatedorzolamide hydrochloride; timolol maleateSolution/Drops;OphthalmicAkorn IncApproval
FuzeonenfuvirtideInjectable;SubcutaneousRocheManufacturing Change or Addition
Methadone Hydrochloridemethadone hydrochloridePowder;For Rx CompoundingMallinckrodtManufacturing Change or Addition
Methadosemethadone hydrochlorideConcentrate;OralMallinckrodtManufacturing Change or Addition
RenovatretinoinCream;TopicalValeant IntlManufacturing Change or Addition
Seasoniqueethinyl estradiol; levonorgestrelTablet;OralTeva Branded PharmManufacturing Change or Addition
Sodium Fluoride F-18sodium fluoride f-18Injectable;IntravenousShertech Labs LlcApproval
Zohydro Erhydrocodone bitartrateCapsule, Extended Release;OralZogenix IncManufacturing Change or Addition
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