New and Generic Drug Approvals

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Drug NameActive Ingredient Dosage Form/RouteSponsor Submission Type
Adrenaclick epinephrineInjectable;Intramuscular, SubcutaneousAmedra Pharms Labeling Revision
Byetta exenatide syntheticInjectable;Subcutaneous Astrazeneca AbManufacturing Change or Addition
ChemetsuccimerCapsule;Oral Recordati RareManufacturing Change or Addition
Clarinexdesloratadine Tablet;OralMerck Sharp DohmeLabeling Revision
Clarinexdesloratadine Syrup;OralMerck Sharp Dohme Labeling Revision
Clarinex desloratadineTablet, Orally Disintegrating;OralMerck Sharp Dohme Labeling Revision
Clarinex desloratadineSyrup; Oral ScheringLabeling Revision
Delflex W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;IntraperitonealFresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;Intraperitoneal Fresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium Low Calcium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;IntraperitonealFresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;Intraperitoneal Fresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;IntraperitonealFresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium Low Calcium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;Intraperitoneal Fresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;IntraperitonealFresenius Medcl Manufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Container calcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;Intraperitoneal Fresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium Low Calcium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactate Solution;IntraperitonealFresenius Medcl Manufacturing Change or Addition
Depocyt cytarabineInjectable, Liposomal;InjectionPacira Pharms Inc Manufacturing Change or Addition
Diovan Hct hydrochlorothiazide; valsartanTablet;Oral NovartisManufacturing Change or Addition
DocetaxeldocetaxelInjectable;Injection SandozLabeling Revision
Juxtapidlomitapide mesylate Capsule;OralAegerionManufacturing Change or Addition
Kuvansapropterin dihydrochloride Tablet;OralBiomarin Pharm Efficacy Supplement with Clinical Data to Support
Memantine Hydrochloride memantine hydrochlorideTablet;Oral Jubilant LifeTentative Approval
NiacinniacinTablet, Extended Release;Oral Sun Pharma GlobalApproval
Niacinniacin Tablet, Extended Release;OralSun Pharma GlobalApproval
Norethindrone Acetate;Ethinyl Estradiol;Ferrous Fumarate norethindrone acetate;ethinyl estradiol;ferrous fumarateTablet;Oral Famy Care LtdApproval
Oluxclobetasol propionateAerosol, Foam;Topical Stiefel Labs IncLabeling Revision
Omtrygomega-3 acid ethyl esters a Capsule;OralTrygg Pharma IncApproval
Spironolactonespironolactone Tablet;OralJubilant Life Approval
Twinject 0.15 epinephrineInjectable;Intramuscular, SubcutaneousAmedra Pharms Labeling Revision
Twinject 0.3 epinephrineInjectable;Intramuscular, Subcutaneous Amedra PharmsLabeling Revision

 

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