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U.S. Department of Health and Human Services

Drugs

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New and Generic Drug Approvals

 

July 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Adderall Xr 10amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 15amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 20amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 25amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 30amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Adderall Xr 5amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCapsule, Extended Release;OralShireLabeling Revision
Crixivanindinavir sulfateCapsule;OralMerck Sharp DohmeLabeling Revision
Forticalcalcitonin salmon recombinantSpray, Metered;NasalUpsher SmithManufacturing Change or Addition

 

July 23, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cardenenicardipine hydrochlorideInjectable;InjectionChiesi Usa IncLabeling Revision
Cardene In 0.83% Sodium Chloride In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncLabeling Revision
Cardene In 0.86% Sodium Chloride In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncLabeling Revision
Cardene In 4.8% Dextrose In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncLabeling Revision
Cardene In 5.0% Dextrose In Plastic Containernicardipine hydrochlorideInjectable;IntravenousChiesi Usa IncLabeling Revision
Edarbiazilsartan kamedoxomilTablet;OralArbor Pharms IrelandLabeling Revision
Edarbyclorazilsartan kamedoxomil; chlorthalidoneTablet;OralArbor Pharms IrelandLabeling Revision
HydrochlorothiazidehydrochlorothiazideTablet;OralSciegen Pharms IncApproval
Targiniq Eroxycodone hydrochloride;naloxone hydrochlorideTablet, Extended Release;OralPurdue FrederickApproval
Terazol 3terconazoleSuppository;VaginalJanssen PharmsLabeling Revision
Terazol 3terconazoleCream;VaginalJanssen PharmsLabeling Revision
Terazol 7terconazoleCream;VaginalJanssen PharmsLabeling Revision
TestosteronetestosteroneGel;TransdermalTeva PharmsLabeling Revision
ZydeligidelalisibTablet;OralGilead Sciences IncApproval
ZydeligidelalisibTablet;OralGilead Sciences IncApproval

 

July 22, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Claritin Hives Relief ReditabloratadineTablet, Orally Disintegrating;OralSchering PloughLabeling Revision
Claritin ReditabsloratadineTablet, Orally Disintegrating;OralSchering PloughLabeling Revision
Claritin ReditabsloratadineTablet, Orally Disintegrating;OralSchering PloughLabeling Revision
CytoxancyclophosphamideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Cytoxan (Lyophilized)cyclophosphamideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
DesonatedesonideGel;TopicalBayer HlthcareLabeling Revision
Lotensin Hctbenazepril hydrochloride; hydrochlorothiazideTablet;OralUs Pharms Holdings IManufacturing Change or Addition
Lyophilized CytoxancyclophosphamideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
OtezlaapremilastTablet;OralCelgene CorpManufacturing Change or Addition
Ryanodexdantrolene sodiumSuspension;InjectableEagle PharmsApproval
Solu-Cortefhydrocortisone sodium succinateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Solu-Medrolmethylprednisolone sodium succinateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
TacrolimustacrolimusCapsule;OralStrides Arcolab LtdApproval
Teveteneprosartan mesylateTablet;OralAbbvieLabeling Revision
Teveten Hcteprosartan mesylate; hydrochlorothiazideTablet;OralAbbvieLabeling Revision
XelodacapecitabineTablet;OralHoffmann La RocheManufacturing Change or Addition
Zoledronic Acidzoledronic acidInjectable;InjectionSun Pharma GlobalTentative Approval

 

July 21, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Brompheniramine Maleate;Pseudoephedrine Hcl;Dextromethorphan Hydrobromidebrompheniramine maleate;pseudoephedrine hcl;dextromethorphan hydrobromideSyrup;OralVintage PharmsApproval
Fiorinalaspirin; butalbital; caffeineCapsule;OralWatson Labs IncManufacturing Change or Addition
Fiorinalaspirin; butalbital; caffeineTablet;OralWatson Labs IncManufacturing Change or Addition
Pennsaiddiclofenac sodiumSolution;TopicalMallinckrodt IncManufacturing Change or Addition
Qvar 40beclomethasone dipropionateAerosol, Metered;InhalationTeva Branded PharmLabeling Revision
Qvar 80beclomethasone dipropionateAerosol, Metered;InhalationTeva Branded PharmLabeling Revision

 

July 18, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Atropine Sulfateatropine sulfateSolution;OphthalmicAkorn IncApproval
BravelleurofollitropinInjectable;Intramuscular, SubcutaneousFerringManufacturing Change or Addition
BrilintaticagrelorTablet;OralAstrazeneca LpManufacturing Change or Addition
Desvenlafaxinedesvenlafaxine fumarateTablet, Extended Release;OralTeva Pharms UsaLabeling Revision
Desvenlafaxinedesvenlafaxine fumarateTablet, Extended Release;OralSun Pharma GlobalLabeling Revision
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapManufacturing Change or Addition
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapManufacturing Change or Addition
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapManufacturing Change or Addition
Elliotts B Solutioncalcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate, dibasic, heptahydrateInjectable;IntrathecalLukare Medical LlcManufacturing Change or Addition
EtomidateetomidateInjectable;InjectionZydus Pharms Usa IncApproval
Fetzimalevomilnacipran hydrochlorideCapsule, Extended Release;OralForest Labs IncLabeling Revision
Fluoxetine Hydrochloridefluoxetine hydrochlorideTablet;OralEdgemont Pharms LlcLabeling Revision
KinevacsincalideInjectable;InjectionBraccoManufacturing Change or Addition
Luvoxfluvoxamine maleateTablet;OralAni PharmsLabeling Revision
MesnamesnaInjectable;InjectionAgila SpecltsApproval
OxytroloxybutyninFilm, Extended Release;TransdermalWatson Labs (Utah)Manufacturing Change or Addition
Paxilparoxetine hydrochlorideTablet;OralApotex TechnologiesLabeling Revision
Paxilparoxetine hydrochlorideSuspension;OralApotex TechnologiesLabeling Revision
Paxil Crparoxetine hydrochlorideTablet, Extended Release;OralApotex TechnologiesLabeling Revision
Pexevaparoxetine mesylateTablet;OralNoven TherapLabeling Revision
Prozacfluoxetine hydrochlorideCapsule;OralEli Lilly and CoLabeling Revision
Prozac Weeklyfluoxetine hydrochlorideCapsule, Delayed Rel Pellets;OralLillyLabeling Revision
RemeronmirtazapineTablet;OralOrganon Usa IncLabeling Revision
Remeron SoltabmirtazapineTablet, Orally Disintegrating;OralOrganon Usa IncLabeling Revision
Sarafemfluoxetine hydrochlorideCapsule;OralEli Lilly and CoLabeling Revision
Stalevo 100carbidopa; entacapone; levodopaTablet;OralOrion PharmaLabeling Revision
Stalevo 125carbidopa; entacapone; levodopaTablet;OralOrion PharmaLabeling Revision
Stalevo 150carbidopa; entacapone; levodopaTablet;OralOrion PharmaLabeling Revision
Stalevo 200carbidopa; entacapone; levodopaTablet;OralOrion PharmaLabeling Revision
Stalevo 50carbidopa; entacapone; levodopaTablet;OralOrion PharmaLabeling Revision
Stalevo 75carbidopa; entacapone; levodopaTablet;OralOrion PharmaLabeling Revision
Symbyaxfluoxetine hydrochloride; olanzapineCapsule;OralLillyLabeling Revision
TopicortdesoximetasoneSpray;TopicalTaroManufacturing Change or Addition
Venlafaxine Hydrochloridevenlafaxine hydrochlorideTablet, Extended Release;OralOsmotica PharmLabeling Revision
Vyvanselisdexamfetamine dimesylateCapsule;OralShire DevelopmentLabeling Revision

 

July 17, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abacavir Sulfate; Lamivudineabacavir sulfate; lamivudineTablet; OralTeva PharmsTentative Approval
Adagenpegademase bovineInjectable;InjectionSigma TauManufacturing Change or Addition
Brintellixvortioxetine hydrobromideTablet;OralTakeda Pharms UsaLabeling Revision
Cymbaltaduloxetine hydrochlorideCapsule, Delayed Rel Pellets;OralLillyLabeling Revision
Desyreltrazodone hydrochlorideTablet;OralApotheconLabeling Revision
Epi E Z Pen JrepinephrineInjectable;IntramuscularMylan SpecltLabeling Revision
EpipenepinephrineInjectable;Intramuscular, SubcutaneousMylan SpecltLabeling Revision
Epipen E Z PenepinephrineInjectable;IntramuscularMylan SpecltLabeling Revision
Epipen Jr.epinephrineInjectable;Intramuscular, SubcutaneousMylan SpecltLabeling Revision
Forfivo Xlbupropion hydrochlorideTablet, Extended Release;OralEdgemont Pharms LlcLabeling Revision
Oleptrotrazodone hydrochlorideTablet, Extended Release;OralAngelini PharmaLabeling Revision
Pristiqdesvenlafaxine succinateTablet, Extended Release;OralWyeth Pharms IncLabeling Revision
Ropivacaine Hydrochlorideropivacaine hydrochlorideInjectable; InjectionNavinta LlcApproval
Sinemetcarbidopa; levodopaTablet;OralMerck Sharp DohmeLabeling Revision
Sinemet Crcarbidopa; levodopaTablet, Extended Release;OralMerck Sharp DohmeLabeling Revision
Surmontiltrimipramine maleateCapsule;OralOdyssey PharmsLabeling Revision
Tudorza Pressairaclidinium bromidePowder, Metered;InhalationForest Labs IncLabeling Revision
Vivactilprotriptyline hydrochlorideTablet;OralTeva WomensLabeling Revision
Wellbutrinbupropion hydrochlorideTablet;OralGlaxosmithklineLabeling Revision
Wellbutrin Srbupropion hydrochlorideTablet, Extended Release;OralGlaxosmithklineLabeling Revision
Zosyn In Plastic Containerpiperacillin sodium; tazobactam sodiumInjectable;InjectionWyeth Pharms IncManufacturing Change or Addition

 

July 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Hexadroldexamethasone sodium phosphateInjectable;InjectionOrganon Usa IncLabeling Revision
KhedezladesvenlafaxineTablet, Extended Release;OralOsmotica Pharm CorpLabeling Revision
Promactaeltrombopag olamineTablet;OralGlaxosmithklineLabeling Revision
Viibrydvilazodone hydrochlorideTablet;OralForest Labs IncLabeling Revision

 

July 15, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Arixtrafondaparinux sodiumInjectable;SubcutaneousAgiLabeling Revision
Brompheniramine Maleate; Pseudoephedrine Hydrochloride; Dextromethorphan Hydrobromidebrompheniramine maleate;pseudoephedrine hydrochloride;dextromethorphan hydrobromideSyrup;OralPaddock LabsApproval
DemsermetyrosineCapsule;OralAton Pharma VpnaManufacturing Change or Addition
Excedrin (Migraine)acetaminophen; aspirin; caffeineTablet;OralNovartisLabeling Revision
SancusogranisetronFilm, Extended Release;TransdermalProstrakan IncManufacturing Change or Addition
Sodium Lactate In Plastic Containersodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Solodynminocycline hydrochlorideTablet, Extended Release;OralMedicisManufacturing Change or Addition
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsManufacturing Change or Addition
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsManufacturing Change or Addition

 

July 14, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
FluocinonidefluocinonideCream; TopicalGlenmark GenericsApproval
FluocinonidefluocinonideCream; TopicalTaro PharmaApproval
FluocinonidefluocinonideCream; TopicalFougera PharmsApproval
Infuvite Pediatric (Pharmacy Bulk Package)ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin kInjectable;Iv (Infusion)SandozLabeling Revision
Omnitropesomatropin recombinantInjectable;InjectionSandozManufacturing Change or Addition
Ritalinmethylphenidate hydrochlorideTablet;OralNovartisManufacturing Change or Addition
Sinequandoxepin hydrochlorideCapsule;OralPfizerLabeling Revision
Sinequandoxepin hydrochlorideConcentrate;OralPfizerLabeling Revision

 

July 11, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Atriplaefavirenz; emtricitabine; tenofovir disoproxil fumarateTablet;OralGileadManufacturing Change or Addition
BravelleurofollitropinInjectable;Intramuscular, SubcutaneousFerringManufacturing Change or Addition
Compleraemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTablet;OralGilead Sciences IncManufacturing Change or Addition
Kadcylaado-trastuzumab emtansineVial; Single-UseGenentechLabeling Revision
Menopurmenotropins (fsh;lh)Injectable;SubcutaneousFerringManufacturing Change or Addition
Rythmolpropafenone hydrochlorideTablet;OralGlaxosmithkline LlcManufacturing Change or Addition
Rythmol Srpropafenone hydrochlorideCapsule, Extended Release;OralGlaxosmithkline LlcManufacturing Change or Addition
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsLabeling Revision
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsLabeling Revision
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsLabeling Revision
Truvadaemtricitabine; tenofovir disoproxil fumarateTablet;OralGileadManufacturing Change or Addition
Vprivvelaglucerase alfaInjectable;Iv (Infusion)Shire Human GeneticManufacturing Change or Addition
Vprivvelaglucerase alfaPowder;Iv (Infusion)Shire Human GeneticManufacturing Change or Addition
Wellbutrin Xlbupropion hydrochlorideTablet, Extended Release;OralValeant IntlLabeling Revision

 

July 10, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Anafranilclomipramine hydrochlorideCapsule;OralMallinckrodt LlcLabeling Revision
DocetaxeldocetaxelInjectable;InjectionHospira IncEfficacy Supplement with Clinical Data to Support
Namendamemantine hydrochlorideSolution;OralForest LabsManufacturing Change or Addition
Pamelornortriptyline hydrochlorideSolution;OralMallinckrodt IncLabeling Revision
Pamelornortriptyline hydrochlorideCapsule;OralMallinckrodt LlcLabeling Revision
Pennsaiddiclofenac sodiumSolution;TopicalMallinckrodt IncManufacturing Change or Addition
Qnaslbeclomethasone dipropionateAerosol, Metered;NasalTeva Branded PharmLabeling Revision
RasuvomethotrexateInjectable;InjectionMedac Pharma IncApproval
Resculaunoprostone isopropylSolution/Drops;OphthalmicSucampo PharmsManufacturing Change or Addition
Tofranil-Pmimipramine pamoateCapsule;OralMallinckrodt IncLabeling Revision

 

July 9, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aplenzinbupropion hydrobromideTablet, Extended Release;OralValeant BermudaLabeling Revision
CaystonaztreonamFor Solution;InhalationGileadManufacturing Change or Addition
Forticalcalcitonin salmon recombinantSpray, Metered;NasalUpsher SmithLabeling Revision
LinzesslinaclotideCapsule;OralForest Labs IncLabeling Revision

 

July 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Celexacitalopram hydrobromideTablet;OralForest LabsLabeling Revision
Conrayiothalamate meglumineInjectable;InjectionMallinckrodtLabeling Revision
Conray 43iothalamate meglumineInjectable;InjectionMallinckrodtLabeling Revision
Crestorrosuvastatin calciumTablet;OralIprLabeling Revision
Frovatriptan Succinatefrovatriptan succinateTablet;OralMylan Pharms IncTentative Approval
Quetiapine Fumaratequetiapine fumarateTablet, Extended Release;OralMylan Pharms IncTentative Approval
Valchlormechlorethamine hydrochlorideGel;TopicalActelion Pharms LtdLabeling Revision
Valchlormechlorethamine hydrochlorideGel;TopicalActelion Pharms LtdManufacturing Change or Addition
Vantashistrelin acetateImplant;SubcutaneousEndo PharmLabeling Revision

 

July 7, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
DesvenlafaxinedesvenlafaxineTablet, Extended Release;OralAlembic Pharms LtdLabeling Revision
Effexor Xrvenlafaxine hydrochlorideCapsule, Extended Release;OralWyeth Pharms IncLabeling Revision
Indium In-111 Oxyquinolineindium in-111 oxyquinolineInjectable;InjectionGe HealthcareManufacturing Change or Addition
KerydintavaboroleSolution;TopicalAnacor Pharms IncApproval
Marqibo Kitvincristine sulfateInjectable, Liposomal;IntravenousTalon TherapManufacturing Change or Addition
TelmisartantelmisartanTablet; OralGlenmark GenericsApproval
TelmisartantelmisartanTablet; OralAlembic LtdApproval
TelmisartantelmisartanTablet;OralMylan Pharms IncApproval
TelmisartantelmisartanTablet;OralTorrent PharmsApproval

 

July 3, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aristocorttriamcinolone diacetateInjectable;InjectionSandozLabeling Revision
Aristocorttriamcinolone diacetateInjectable;InjectionSandozLabeling Revision
Aristospantriamcinolone hexacetonideInjectable;InjectionSandozLabeling Revision
Benicarolmesartan medoxomilTablet;OralDaiichi SankyoManufacturing Change or Addition
Celestone Soluspanbetamethasone acetate; betamethasone sodium phosphateInjectable;InjectionMerck Sharp DohmeLabeling Revision
Clonidine Hydrochlorideclonidine hydrochlorideTablet;OralCaracoApproval
CyanokithydroxocobalaminInjectable;InjectionMerck Sante SasManufacturing Change or Addition
Depo-Medrolmethylprednisolone acetateInjectable;InjectionPharmacia and UpjohnLabeling Revision
DigoxindigoxinElixir;OralRoxaneManufacturing Change or Addition
DocetaxeldocetaxelInjectable;InjectionAccord HlthcareLabeling Revision
DovonexcalcipotrieneOintment;TopicalLeo Pharma AsManufacturing Change or Addition
Fluphenazine Decanoatefluphenazine decanoateInjectable;InjectionPar Sterile ProductsApproval
Ibuprofen and Phenylephrine Hydrochlorideibuprofen; phenylephrine hydrochlorideTablet;OralPerrigo R and DApproval
IlevronepafenacSuspension/Drops;OphthalmicAlcon Res LtdManufacturing Change or Addition
ImplanonetonogestrelImplant;ImplantationOrganon Usa IncLabeling Revision
Kenalog-10triamcinolone acetonideInjectable;InjectionApotheconLabeling Revision
Kenalog-40triamcinolone acetonideInjectable;InjectionApotheconLabeling Revision
Namenda Xrmemantine hydrochlorideCapsule, Extended Release;OralForest LabsEfficacy Supplement with Clinical Data to Support
NexplanonetonogestrelImplant;ImplantationOrganon Usa IncLabeling Revision
RapamunesirolimusTablet;OralPf Prism CvManufacturing Change or Addition
Solu-Cortefhydrocortisone sodium succinateInjectable;InjectionPharmacia and UpjohnLabeling Revision
Solu-Medrolmethylprednisolone sodium succinateInjectable;InjectionPharmacia and UpjohnLabeling Revision
Trelstartriptorelin pamoateInjectable;IntramuscularWatson LabsManufacturing Change or Addition
TrileptaloxcarbazepineTablet;OralNovartisLabeling Revision
TrileptaloxcarbazepineSuspension;OralNovartisLabeling Revision
Zoledronic Acidzoledronic acidInjectable;InjectionSun Pharma GlobalTentative Approval
Zoloftsertraline hydrochlorideTablet;OralPfizerLabeling Revision
Zoloftsertraline hydrochlorideConcentrate;OralPfizerLabeling Revision

 

July 2, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Azoramlodipine besylate; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Bendamustine Hydrochloride Injectionbendamustine hydrochlorideInjectable; InjectionEagle PharmsTentative Approval
LetairisambrisentanTablet;OralGileadManufacturing Change or Addition
Norpramindesipramine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Qualaquinquinine sulfateCapsule;OralMutual Pharm Co IncLabeling Revision

 

July 1, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AfinitoreverolimusTablet;OralNovartisLabeling Revision
Afinitor DisperzeverolimusTablet, For Suspension;OralNovartis PharmLabeling Revision
Epiduoadapalene; benzoyl peroxideGel;TopicalGalderma Labs LpManufacturing Change or Addition
Iprivaskdesirudin recombinantInjectable;SubcutaneousMarathon Pharms LlcManufacturing Change or Addition
LinzesslinaclotideCapsule;OralForest Labs IncManufacturing Change or Addition
Lithium Citratelithium citrateSyrup;OralRoxaneManufacturing Change or Addition
M.V.I. Adultascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e; vitamin kInjectable;Iv (Infusion)HospiraManufacturing Change or Addition
Premphase 14/14estrogens, conjugated; medroxyprogesterone acetateTablet;Oral-28Wyeth Pharms IncManufacturing Change or Addition
Premproestrogens, conjugated; medroxyprogesterone acetateTablet;Oral-28Wyeth Pharms IncManufacturing Change or Addition

 

June 30, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ArgatrobanargatrobanInjectable;InjectionPar Sterile ProductsApproval
ArgatrobanargatrobanInjectable;InjectionMylan InstitutionalApproval
ButransbuprenorphineFilm, Extended Release;TransdermalPurdue Pharma LpLabeling Revision
ButransbuprenorphineFilm, Extended Release;TransdermalPurdue Pharma LpManufacturing Change or Addition
Chloraprep One-Stepchlorhexidine gluconate; isopropyl alcoholSponge;TopicalCarefusionLabeling Revision
Chloraprep One-Step Freppchlorhexidine gluconate; isopropyl alcoholSponge;TopicalCarefusionLabeling Revision
Chloraprep One-Step Seppchlorhexidine gluconate; isopropyl alcoholSwab;TopicalCarefusionLabeling Revision
Chloraprep Single Swabstickchlorhexidine gluconate; isopropyl alcoholSwab;TopicalCarefusionLabeling Revision
Chloraprep Triple Swabstickchlorhexidine gluconate; isopropyl alcoholSwab;TopicalCarefusionLabeling Revision
Chloraprep With Tintchlorhexidine gluconate; isopropyl alcoholSponge;TopicalCarefusionLabeling Revision
FaslodexfulvestrantInjectable;IntramuscularAstrazenecaManufacturing Change or Addition
HerceptintrastuzumabVial; IntravenousGenentechLabeling Revision
Hibiclenschlorhexidine gluconateSolution;TopicalMolnlycke HlthLabeling Revision
MyaleptmetreleptinInjectable;InjectionAmylin Pharms LlcLabeling Revision

 

June 28, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
OzurdexdexamethasoneImplant;IntravitrealAllerganNew or Modified Indication
Symbicortbudesonide; formoterol fumarate dihydrateAerosol, Metered;InhalationAstrazenecaManufacturing Change or Addition

 

June 27, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Afrezzainsulin humanPowder;InhalationMannkind CorpApproval
Ammonia N 13ammonia n-13Injectable;IntravenousUniv Tx Md AndersonApproval
Benicarolmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Benicar Hcthydrochlorothiazide; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Buprenorphine Hydrochloride and Naloxone Hydrochloridebuprenorphine hydrochloride; naloxone hydrochlorideTablet;SublingualRoxaneApproval
Buprenorphine Hydrochloride and Naloxone Hydrodhcloridebuprenorphine hydrochloride; naloxone hydrochlorideTablet;SublingualRoxaneApproval
Ceretectechnetium tc-99m exametazime kitInjectable;InjectionGe HealthcareManufacturing Change or Addition
Desmopressin Acetatedesmopressin acetateTablet;OralMylan Pharms IncApproval
Doxorubicin Hydrochloridedoxorubicin hydrochlorideInjectable;InjectionActavis IncApproval
Eletriptan Hydrobromideeletriptan hydrobromideTablet; OralTeva Pharms UsaTentative Approval
Ellaulipristal acetateTablet;OralLab Hra PharmaManufacturing Change or Addition
FurosemidefurosemideInjectable;InjectionLuitpoldManufacturing Change or Addition
GazyvaobinutuzumabInjectable;InjectionGenentechLabeling Revision
Lupron Depotleuprolide acetateInjectable;InjectionAbbvie Endocrine IncLabeling Revision
Lupron Depotleuprolide acetateInjectable;InjectionAbbvie Endocrine IncLabeling Revision
Oxymorphone Hydrochlorideoxymorphone hydrochlorideTablet, Extended Release;OralMallinckrodt IncApproval
Symlinpramlintide acetateInjectable;SubcutaneousAstrazeneca AbEfficacy Supplement with Clinical Data to Support
Symlinpramlintide acetateInjectable;SubcutaneousAstrazeneca AbLabeling Revision
TaxolpaclitaxelInjectable;InjectionHq Spclt PharmaManufacturing Change or Addition
Tribenzoramlodipine besylate; hydrochlorothiazide; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Vazculepphenylephrine hydrochlorideInjectable; InjectionEclat Pharms LlcApproval
VirazoleribavirinFor Solution;InhalationValeant Pharm IntlManufacturing Change or Addition

 

June 26, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cleocin Hydrochlorideclindamycin hydrochlorideCapsule;OralPharmacia and UpjohnLabeling Revision
Gattex Kitteduglutide recombinantPowder;SubcutaneousNps Pharms IncEfficacy Supplement with Clinical Data to Support
K-Tabpotassium chlorideTablet, Extended Release;OralAbbvieManufacturing Change or Addition
Potassium Chloridepotassium chlorideTablet, Extended Release;OralAbbvieManufacturing Change or Addition
ValsartanvalsartanTablet;OralOhm Labs IncApproval
VarithenapolidocanolSolution;IntravenousProvensisManufacturing Change or Addition
ZestrillisinoprilTablet;OralAstrazenecaLabeling Revision

 

June 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cleocin Phosphate In Dextrose 5% In Plastic Containerclindamycin phosphateInjectable;InjectionPharmacia and UpjohnLabeling Revision
FamvirfamciclovirTablet;OralNovartisManufacturing Change or Addition
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCapsule;OralAmneal PharmsTentative Approval
Lisdexamfetamine Dimesylatelisdexamfetamine dimesylateCapsule;OralMylan Pharms IncTentative Approval

 

June 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cardizemdiltiazem hydrochlorideTablet;OralValeant IntlManufacturing Change or Addition
Chlorhexidine Gluconatechlorhexidine gluconateCloth;TopicalSage ProdsLabeling Revision
Elelysotaliglucerase alfaPowder;Iv (Infusion)PfizerManufacturing Change or Addition
Fusilevlevoleucovorin calciumPowder;Iv (Infusion)Spectrum PharmsManufacturing Change or Addition
Fusilevlevoleucovorin calciumSolution;Iv (Infusion)Spectrum PharmsManufacturing Change or Addition
ImiquimodimiquimodCream;TopicalStrides Arcolab LtdApproval
Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersCapsule;OralPar Pharm IncApproval
ParicalcitolparicalcitolCapsule;OralDr Reddys Labs LtdApproval
ParicalcitolparicalcitolCapsule;OralAnchen PharmsApproval
Ravictiglycerol phenylbutyrateLiquid;OralHyperion Therap IncLabeling Revision
Solu-Cortefhydrocortisone sodium succinateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
VfendvoriconazoleInjectable;Iv (Infusion)PfizerManufacturing Change or Addition
ZithromaxazithromycinInjectable;InjectionPfizerManufacturing Change or Addition
Zosyn In Plastic Containerpiperacillin sodium; tazobactam sodiumInjectable;InjectionWyeth Pharms IncManufacturing Change or Addition