Drugs

New and Generic Drug Approvals

 

August 25, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Codeine Phosphate and Chlorpheniramine Maleatechlorpheniramine maleate; codeine phosphateTablet, Extended Release;OralSpriaso LlcLabeling Revision
Gleevecimatinib mesylateTablet;OralNovartisEfficacy Supplement with Clinical Data to Support
Gleevecimatinib mesylateTablet;OralNovartisLabeling Revision
Neuraceqflorbetaben f-18Solution;IntravenousPiramal ImagingLabeling Revision
Trivagizole 3clotrimazoleCream;VaginalTaroLabeling Revision
XareltorivaroxabanTablet;OralJanssen PharmsLabeling Revision

 

August 24, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Amoxicillin and Clavulanate Potassiumamoxicillin; clavulanate potassiumTablet;OralHikma PharmsApproval
Calanverapamil hydrochlorideTablet;OralGd Searle LlcLabeling Revision
Calanverapamil hydrochlorideInjectable;InjectionGd Searle LlcLabeling Revision
Calan Srverapamil hydrochlorideTablet, Extended Release;OralPfizerLabeling Revision
Codeine Sulfatecodeine sulfateSolution;OralRoxaneManufacturing Change or Addition
Covera-Hsverapamil hydrochlorideTablet, Extended Release;OralGd Searle LlcLabeling Revision
Ethacrynate Sodiumethacrynate sodiumInjectable;InjectionMylan InstitutionalApproval
Fortametmetformin hydrochlorideTablet, Extended Release;OralAndrx Labs LlcManufacturing Change or Addition
PacitaxelpaclitaxelInjectable;InjectionGland Pharma LtdApproval
ParoxetineparoxetineTablet, Extended Release;OralLupin LtdTentative Approval
RhinocortbudesonideSpray, Metered;NasalAstrazeneca PharmsLabeling Revision
Rhinocort AllergybudesonideSpray, Metered;NasalAstrazeneca PharmsLabeling Revision
Trospium Chloridetrospium chlorideTablet;OralInvagen PharmsApproval
XareltorivaroxabanTablet; OralJanssen PharmsManufacturing Change or Addition

 

August 23, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Lamisilterbinafine hydrochlorideTablet;OralNovartisLabeling Revision
Lamisilterbinafine hydrochlorideGranule;OralNovartisLabeling Revision
Ranitidine Hydrochlorideranitidine hydrochlorideTablet;OralStrides PharmaApproval
VidazaazacitidineInjectable;Intravenous, SubcutaneousCelgeneLabeling Revision
Zyrtec Allergycetirizine hydrochlorideTablet, Orally Disintegrating;OralJ and J Consumer IncLabeling Revision

 

August 22, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
BanzelrufinamideTablet;OralEisai IncManufacturing Change or Addition
LinezolidlinezolidTablet;OralNovel Labs IncApproval
Loestrin 24 Feethinyl estradiol; norethindrone acetateTablet;OralWarner ChilcottLabeling Revision
Melphalan Hydrochloridemelphalan hydrochlorideInjectable;InjectionPar Sterile ProductsApproval
Movantiknaloxegol oxalateTablet;OralAstrazeneca PharmsLabeling Revision
Nitroglycerin In Dextrose 5%nitroglycerinInjectable;InjectionBaxter HlthcareLabeling Revision
Palonosetron Hydrochloridepalonosetron hydrochlorideInjectable;InjectionExela Pharma Scs LlcApproval
TrecatorethionamideTablet;OralWyeth Pharms IncLabeling Revision
XareltorivaroxabanTablet;OralJanssen PharmsManufacturing Change or Addition

 

August 21, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Omeprazole and Sodium Bicarbonateomeprazole; sodium bicarbonateCapsule;OralAurolife Pharma LlcApproval

 

August 19, 2016

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bupropion Hydrochloridebupropion hydrochlorideTablet;OralHeritage PharmaApproval
DaytranamethylphenidateFilm, Extended Release;TransdermalNoven Pharms IncLabeling Revision
Doxylamine Succinate and Pyridoxine Hydrochloridedoxylamine succinate; pyridoxine hydrochlorideTablet, Delayed Release;OralActavis Labs Fl IncApproval
FelodipinefelodipineTablet, Extended Release;OralJubilant GenericsApproval
Fluoxetine Hydrochloridefluoxetine hydrochlorideTablet;OralPar FormApproval
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarateethinyl estradiol; norethindrone acetateCapsule;OralApilLabeling Revision
Patanololopatadine hydrochlorideSolution/Drops;OphthalmicAlconManufacturing Change or Addition
PitocinoxytocinInjectable;InjectionPar Sterile ProductsManufacturing Change or Addition
Potassium Chloridepotassium chlorideTablet, Extended Release;OralSigmapharm Labs LlcApproval
Rosuvastatin Calciumrosuvastatin calciumTablet;OralBiocon LimitedTentative Approval
Simponi AriagolimumabInjectable; InjectionJanssen BiotechLabeling Revision
Sodium Sulfate; Potassium Sulfate; Magnesium Sulfatesodium sulfate;potassium sulfate;magnesium sulfateUnknownPaddock LabsTentative Approval
TegretolcarbamazepineSuspension;OralNovartisManufacturing Change or Addition
Trifericferric pyrophosphate citrateSolution;Iv (Infusion)Rockwell Medical IncManufacturing Change or Addition
Troxyca Eroxycodone hydrochloride; naltrexone hydrochlorideCapsule;OralPfizer IncApproval
Zoledronic Acidzoledronic acidInjectable;Iv (Infusion)Gland Pharma LtdApproval

 

Page Last Updated: 08/26/2016
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