Drugs

New and Generic Drug Approvals

 

July 21, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Achromycin Vtetracycline hydrochlorideCapsule;OralHeritage Pharms IncManufacturing Change or Addition
Halaveneribulin mesylateSolution;IntravenousEisai IncManufacturing Change or Addition
IlariscanakinumabInjectable; SubcutaneousNovartis PharmsEfficacy Supplement with Clinical Data to Support
Irbesartan and Hydrochlorothiazidehydrochlorothiazide; irbesartanTablet;OralMylan Pharms IncApproval
RelenzazanamivirPowder;InhalationGlaxosmithklineManufacturing Change or Addition

 

July 20, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Clinolipid 20%olive oil; soybean oilInjectable;InjectionBaxter HlthcareLabeling Revision
EliquisapixabanTablet;OralBristol Myers SquibbLabeling Revision
EpivirlamivudineTablet;OralViiv HlthcareEfficacy Supplement with Clinical Data to Support
EpivirlamivudineSolution;OralViiv HlthcareEfficacy Supplement with Clinical Data to Support
FurosemidefurosemideInjectable;InjectionAmneal Pharms CoApproval
Jenlogaclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncManufacturing Change or Addition
Kapvayclonidine hydrochlorideTablet, Extended Release;OralConcordia Pharms IncManufacturing Change or Addition
Phoxillum B22k 4/0 In Plastic Containercalcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphateInjectable;InjectionBaxter HlthcareLabeling Revision
Phoxillum Bk 4/2.5 In Plastic Containercalcium chloride; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphateInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 2/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 2/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 4/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol B22gk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 0/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 2/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 2/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/0/1.2 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bgk 4/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 0/0 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 0/0/1.2 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 0/3.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
Prismasol Bk 4/2.5 In Plastic Containercalcium chloride; dextrose; lactic acid; magnesium chloride; potassium chloride; sodium bicarbonate; sodium chlorideInjectable;InjectionBaxter HlthcareLabeling Revision
YondelistrabectedinPowder;Iv (Infusion)Janssen ProdsLabeling Revision

 

July 19, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
DalfampridinedalfampridineTablet;OralTeva Pharms Usa IncTentative Approval
Doxylamine Succinate; Pyridoxine Hydrochloridedoxylamine succinate;pyridoxine hydrochlorideTablet, Delayed Release;OralActavis Labs Fl IncTentative Approval
Esomeprazole Sodiumesomeprazole sodiumInjectable;InjectionDeva Holding A.S.Tentative Approval
IndomethacinindomethacinCapsule;OralMylanManufacturing Change or Addition
Relistormethylnaltrexone bromideTablet;OralSalix PharmsApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralApotex IncApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralMylan Pharms IncApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralTeva Pharms UsaApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralPar Pharm IncApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralSun Pharma GlobalApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralAurobindo Pharma LtdApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralSandoz IncApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralGlenmark Pharms LtdApproval
Valganciclovir Hydrochloridevalganciclovir hydrochlorideFor Solution;OralActavis Labs Fl IncApproval
Zoladexgoserelin acetateImplant;ImplantationAstrazenecaManufacturing Change or Addition

 

July 18, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Delflex W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 1.5% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 2.5% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Delflex W/ Dextrose 4.25% Low Magnesium In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealFresenius MedclManufacturing Change or Addition
Heparin Sodium 1,000 Units In Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 10,000 Units In Sodium Chloride 0.45%heparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 10,000 Units In Sodium Chloride 0.9%heparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.45% In Plastic Containerheparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 12,500 Units In Sodium Chloride 0.9%heparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 2,000 Units In Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.45% In Plastic Containerheparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 25,000 Units In Sodium Chloride 0.9% In Plastic Containerheparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 5,000 Units In Sodium Chloride 0.45%heparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Heparin Sodium 5,000 Units In Sodium Chloride 0.9%heparin sodiumInjectable;InjectionHospiraManufacturing Change or Addition
Namzaricdonepezil hydrochloride; memantine hydrochlorideCapsule, Extended Release;OralForest Labs LlcEfficacy Supplement with Clinical Data to Support
Penicillin G Potassium In Plastic Containerpenicillin g potassiumInjectable;InjectionBaxter HlthcareLabeling Revision
Veletriepoprostenol sodiumInjectable;InjectionActelion Pharms LtdManufacturing Change or Addition
VimpatlacosamideSolution;IntravenousUcb IncManufacturing Change or Addition

 

July 15, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Belviq Xrlorcaserin hydrochlorideTablet, Extended Release;OralArena Pharmaceuticals IncApproval
Makenahydroxyprogesterone caproateSolution;IntramuscularAmag Pharma UsaManufacturing Change or Addition
NilutamidenilutamideTablet;OralAni Pharms IncApproval
Omeprazole and Sodium Bicarbonateomeprazole; sodium bicarbonateCapsule;OralPerrigo R and DApproval
Omeprazole and Sodium Bicarbonateomeprazole; sodium bicarbonateCapsule;OralPar PharmApproval
Omeprazole and Sodium Bicarbonateomeprazole; sodium bicarbonateCapsule;OralDr Reddys Labs LtdApproval
Omeprazole and Sodium Bicarbonateomeprazole; sodium bicarbonateCapsule;OralActavis ElizabethApproval
Omeprazole and Sodium Bicarbonateomeprazole; sodium bicarbonateCapsule;OralAjanta Pharma LtdApproval
Photrexariboflavin 5'-phosphate sodiumSolution/Drops;OphthalmicAvedro IncApproval
Photrexa Viscous In Dextran 20%riboflavin 5'-phosphate sodiumSolution/Drops;OphthalmicAvedro IncApproval

 

Page Last Updated: 07/22/2016
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