Drugs

New and Generic Drug Approvals

October 30, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ammonia N 13ammonia n 13Injectable;InjectionThe Brigham and Women's Hospital IncApproval
Bystolicnebivolol hydrochlorideTablet;OralForest LabsManufacturing Change or Addition
CelecoxibcelecoxibCapsule;OralLupin LtdApproval
DiflucanfluconazoleTablet;OralPfizerLabeling Revision
DiflucanfluconazoleFor Suspension;OralPfizerLabeling Revision
DocefrezdocetaxelInjectable;InjectionSun Pharma GlobalLabeling Revision
Envarsus XrtacrolimusTablet, Extended Release;OralVeloxis Pharma IncTentative Approval
Fludeoxyglucose F18fludeoxyglucose f18Injectable;InjectionThe Brigham and Women's Hospital IncApproval
Fludeoxyglucose F18fludeoxyglucose f18Injectable;InjectionHot Shots Nm LlcApproval
Humulin Rinsulin recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin R Peninsulin recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Imatinib Mesylateimatinib mesylateTablet;OralApotex IncTentative Approval
LamotriginelamotrigineTablet, Orally Disintegrating;OralPar Pharm IncTentative Approval
Locoidhydrocortisone butyrateCream;TopicalPrecision DermatLabeling Revision
Locoidhydrocortisone butyrateOintment;TopicalPrecision DermatLabeling Revision
Locoidhydrocortisone butyrateSolution;TopicalPrecision DermatLabeling Revision
Locoidhydrocortisone butyrateLotion;TopicalPrecision DermatLabeling Revision
Lopressormetoprolol tartrateTablet;OralUs Pharms Holdings IManufacturing Change or Addition
Montelukast Sodiummontelukast sodiumTablet;OralUnimark Remedies LtdApproval
Montelukast Sodiummontelukast sodiumTablet, Chewable;OralUnimark Remedies LtdApproval
Mycophenolic Acidmycophenolic acidTablet, Delayed Release;OralTeva Pharms UsaApproval
NascobalcyanocobalaminSpray, Metered;NasalPar PharmManufacturing Change or Addition
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumaratenorethindrone acetate;ethinyl estradiol ferrous fumarateTablet;OralFamy Care LtdApproval
NutrestoreglutamineFor Solution;OralEmmaus MedclManufacturing Change or Addition
Omtrygomega-3-acid ethyl estersCapsule;OralTryggManufacturing Change or Addition
OrfadinnitisinoneCapsule;OralSwedish OrphanManufacturing Change or Addition
Symbyaxfluoxetine hydrochloride; olanzapineCapsule;OralLillyManufacturing Change or Addition
Vyvanselisdexamfetamine dimesylateCapsule;OralShire DevelopmentManufacturing Change or Addition
ZavescamiglustatCapsule;OralActelion Pharms LtdManufacturing Change or Addition
ZykadiaceritinibCapsule;OralNovartis Pharms CorpManufacturing Change or Addition

 

October 29, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bio-Tropinsomatropin recombinantInjectable;InjectionFerringLabeling Revision
Dymistaazelastine hydrochloride; fluticasone propionateSpray, Metered;NasalMeda PharmsManufacturing Change or Addition
Edluarzolpidem tartrateTablet;SublingualMeda PharmsLabeling Revision
Fludeoxyglucose F18fludeoxyglucose f18Injectable;InjectionTrustees Of The U Of PennApproval
Fludeoxyglucose F18fludeoxyglucose f18Injectable;InjectionChildrens Hospital Of MiApproval
Fludeoxyglucose F18fludeoxyglucose f18Injectable;InjectionCentre For Probe Dev and CommercializationApproval
HumiraadalimumabSyringeAbbvie IncLabeling Revision
HumiraadalimumabVialAbbvie IncLabeling Revision
LetairisambrisentanTablet;OralGileadSupplement
Naropinropivacaine hydrochlorideInjectable;InjectionFresenius Kabi UsaManufacturing Change or Addition
Piperacillin and Tazobactampiperacillin;tazobactamInjectable;InjectionSandoz IncApproval
Singulairmontelukast sodiumTablet, Chewable;OralMerckManufacturing Change or Addition
Sodium Fluoride F18sodium fluoride f18Injectable;InjectionEssential Isotopes LlcApproval
Tev-Tropinsomatropin recombinantInjectable;InjectionFerringLabeling Revision
Xigduo Xrdapagliflozin;metformin hydrochlorideTablet, Extended Release;OralAstrazeneca AbApproval

 

October 28, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdapaleneadapaleneGel; TopicalActavis Mid AtlanticApproval
CarisoprodolcarisoprodolTablet;OralNatco Pharma LtdApproval
Darunavir Ethanolatedarunavir ethanolateTablet;OralHetero Labs Unit IiiTentative Approval
Hydrocodone Bitartrate; Pseudoephedrine Hydrochloridehydrocodone bitartrate;pseudoephedrine hydrochlorideSolution;OralTris Pharma IncApproval
Idkit:hpcitric acid; urea c-13For Solution, Tablet, For Solution;OralExalenz BioscienceLabeling Revision
MaravirocmaravirocTablet;OralHetero Labs Unit IiiTentative Approval
Metoprolol Tartratemetoprolol tartrateTablet;OralRubicon Research Pvt LtdApproval
Nicardipine Hydrochloridenicardipine hydrochlorideInjectable;InjectionExela Pharma ScienceManufacturing Change or Addition
Quetiapine Fumaratequetiapine fumarateTablet;OralAlembic Pharms LtdApproval
SirolimussirolimusTablet; OralDr Reddys Labs LtdApproval
Somatuline Depotlanreotide acetateInjectable;SubcutaneousIpsen PharmaManufacturing Change or Addition
SoriataneacitretinCapsule;OralStiefel Labs IncManufacturing Change or Addition
Vibramycindoxycycline hyclateCapsule;OralPfizerManufacturing Change or Addition

 

October 27, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ammonia N 13ammonia n 13Injectable;InjectionGlobal Isotopes LlcApproval
Azelastine Hydrochlorideazelastine hydrochlorideSprayRoxaneApproval
Bystolicnebivolol hydrochlorideTablet;OralForest LabsManufacturing Change or Addition
CarisoprodolcarisoprodolTablet;OralOrient Pharma Co LtdApproval
DelzicolmesalamineCapsule, Delayed Release;OralWarner Chilcott LlcLabeling Revision
Dtpatechnetium tc-99m pentetate kitInjectable;InjectionDraximageManufacturing Change or Addition
Fludeoxyglucose F-18fludeoxyglucose f-18Injectable;InjectionGlobal Isotopes LlcApproval
FluocinonidefluocinonideCream;TopicalTaroManufacturing Change or Addition
IvermectinivermectinTablet;OralEdenbridge Pharma LlcApproval
LyricapregabalinSolution;OralNovel Labs IncTentative Approval
Methylphenidate Hydrochloridemethylphenidate hydrochlorideCapsule, Extended Release;OralBarr Labs IncApproval
Nasonexmometasone furoate monohydrateSpray, Metered;NasalMerck Sharp DohmeManufacturing Change or Addition
NevirapinenevirapineTablet, Extended Release;OralMylan Pharms IncApproval
OrfadinnitisinoneCapsule;OralSwedish OrphanManufacturing Change or Addition
Oxymorphone Hydrochlorideoxymorphone hydrochlorideTablet, Extended Release;OralPar Pharm IncApproval
Ritalin Lamethylphenidate hydrochlorideCapsule, Extended Release;OralNovartisManufacturing Change or Addition
Sodium Fluoride F-18sodium fluoride f-18Injectable;InjectionGlobal Isotopes LlcApproval
Trandatelabetalol hydrochlorideTablet;OralPrometheus LabsManufacturing Change or Addition
Ultram Ertramadol hydrochlorideTablet, Extended Release;OralValeant IntlManufacturing Change or Addition
Zyflo CrzileutonTablet, Extended Release;OralChiesi Usa IncManufacturing Change or Addition

 

October 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
CyclophosphamidecyclophosphamideInjectable;InjectionBaxter HlthcareLabeling Revision

 

October 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Dilatrate-Srisosorbide dinitrateCapsule, Extended Release;OralAuxilium Pharms LlcLabeling Revision

 

October 23, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abacavir and Lamivudineabacavir;lamivudineTablet, For Suspension;OralMylan Labs LtdTentative Approval
Abacavir and Lamivudineabacavir;lamivudineTablet;OralMylan Labs LtdTentative Approval
AdrenaclickepinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
Astelinazelastine hydrochlorideSpray, Metered;NasalMeda PharmsLabeling Revision
Cancidascaspofungin acetateInjectable;Iv (Infusion)MerckLabeling Revision
Dilatrate-Srisosorbide dinitrateCapsule, Extended Release;OralAuxilium Pharms LlcLabeling Revision
Finaceaazelaic acidGel;TopicalBayer HlthcareManufacturing Change or Addition
Luvoxfluvoxamine maleateTablet;OralAni PharmsManufacturing Change or Addition
Minocinminocycline hydrochlorideInjectable;InjectionRempex Pharms IncLabeling Revision
Phenylephrine Hydrochloridephenylephrine hydrochlorideSolution;Iv (Infusion)West Ward Pharm CorpManufacturing Change or Addition
Sodium Iodide I 131sodium iodide i-131Capsule;OralMallinckrodtManufacturing Change or Addition
Somatuline Depotlanreotide acetateInjectable;SubcutaneousIpsen PharmaManufacturing Change or Addition
Tudorza Pressairaclidinium bromidePowder, Metered;InhalationForest Labs IncManufacturing Change or Addition
Twinject 0.15epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
Twinject 0.3epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
UloricfebuxostatTablet;OralTakeda Pharms UsaManufacturing Change or Addition
ZetonnaciclesonideAerosol, Metered;NasalTakeda GmbhEfficacy Supplement with Clinical Data to Support

 

October 22, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aldactazidehydrochlorothiazide; spironolactoneTablet;OralGd Searle LlcLabeling Revision
AldactonespironolactoneTablet;OralGd Searle LlcLabeling Revision
Ms Continmorphine sulfateTablet, Extended Release;OralPurdue Pharma LpLabeling Revision
Oxycontinoxycodone hydrochlorideTablet, Extended Release;OralPurdue Pharma LpLabeling Revision
Sotylizesotalol hydrochlorideSolution;OralArbor Pharms LlcApproval

 

October 21, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Effexor Xrvenlafaxine hydrochlorideCapsule, Extended Release;OralWyeth Pharms IncLabeling Revision
Flomaxtamsulosin hydrochlorideCapsule;OralBoehringer IngelheimLabeling Revision
ParicalcitolparicalcitolInjectable;InjectionHospira IncApproval
Saphrisasenapine maleateTablet;SublingualForest Labs IncLabeling Revision
TopamaxtopiramateTablet;OralJanssen PharmsLabeling Revision
TopamaxtopiramateCapsule;OralJanssen PharmsLabeling Revision
Topamax SprinkletopiramateCapsule;OralJanssen PharmsLabeling Revision

 

October 20, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AbsoricaisotretinoinCapsule;OralRanbaxyManufacturing Change or Addition
AfinitoreverolimusTablet;OralNovartisManufacturing Change or Addition
Bonivaibandronate sodiumInjectable;IntravenousRocheManufacturing Change or Addition
Cleocin Phosphateclindamycin phosphateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
Dutoprolhydrochlorothiazide; metoprolol succinateTablet, Extended Release;OralCovis Pharma SarlLabeling Revision
Nexium Ivesomeprazole sodiumInjectable;IntravenousAstrazenecaManufacturing Change or Addition
Tarkatrandolapril; verapamil hydrochlorideTablet, Extended Release;OralAbbvieManufacturing Change or Addition
Xiaflexcollagenase clostridium histolyticumSolution; InjectionAuxilium PharmsEfficacy Supplement with Clinical Data to Support

 

October 17, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdrenaclickepinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
AubagioteriflunomideTablet;OralSanofi Aventis UsEfficacy Supplement with Clinical Data to Support
Combivent Respimatalbuterol sulfate; ipratropium bromideSpray, Metered;InhalationBoehringer IngelheimLabeling Revision
Embedamorphine sulfate; naltrexone hydrochlorideCapsule, Extended Release;OralAlpharma PharmsEfficacy Supplement with Clinical Data to Support
Exidinechlorhexidine gluconateSolution;TopicalXttriumLabeling Revision
Sirturobedaquiline fumarateTablet;OralJanssen TherapLabeling Revision
Twinject 0.15epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
Twinject 0.3epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition

 

October 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ArgatrobanargatrobanInjectable;InjectionHikma Pharm Co LtdManufacturing Change or Addition
Cymbaltaduloxetine hydrochlorideCapsule, Delayed Rel Pellets;OralLillyEfficacy Supplement with Clinical Data to Support
Fiorinalaspirin; butalbital; caffeineCapsule;OralWatson Labs IncManufacturing Change or Addition
Fiorinalaspirin; butalbital; caffeineTablet;OralWatson Labs IncManufacturing Change or Addition
Hylenex Recombinanthyaluronidase recombinant humanInjectable;InjectionHalozyme TherapManufacturing Change or Addition
IlariscanakinumabInjectable; SubcutaneousNovartis PharmsLabeling Revision
IndocinindomethacinSuspension;OralIroko PharmsManufacturing Change or Addition
LialdamesalamineTablet, Delayed Release;OralShireLabeling Revision
Megace Esmegestrol acetateSuspension;OralPar PharmManufacturing Change or Addition
Vascepaicosapent ethylCapsule;OralAmarin PharmsManufacturing Change or Addition
XelodacapecitabineTablet;OralHoffmann La RocheLabeling Revision

 

October 15, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aciphexrabeprazole sodiumTablet, Delayed Release;OralEisai IncLabeling Revision
Aciphex Sprinklerabeprazole sodiumCapsule, Delayed Release;OralEisai IncLabeling Revision
Chantixvarenicline tartrateTablet;OralPfizer IncEfficacy Supplement with Clinical Data to Support
Chantixvarenicline tartrateTablet;OralPfizer IncLabeling Revision
Curosurfporactant alfaSuspension;IntratrachealChiesi Usa IncManufacturing Change or Addition
Duacbenzoyl peroxide; clindamycin phosphateGel;TopicalStiefelManufacturing Change or Addition
ErivedgevismodegibCapsule;OralGenentechManufacturing Change or Addition
EsbrietpirfenidoneCapsule;OralIntermune IncApproval
IstodaxromidepsinPowder;Iv (Infusion)CelgeneEfficacy Supplement with Clinical Data to Support
Marqibo Kitvincristine sulfateInjectable, Liposomal;IntravenousTalon TherapManufacturing Change or Addition
Neuraceqflorbetaben f-18Solution;IntravenousPiramal ImagingManufacturing Change or Addition
OfevnintedanibCapsule;OralBoehringer IngelheimApproval

 

October 14, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Lymphoseek Kittechnetium tc-99m tilmanoceptInjectable;InjectionNavidea BiopharmsEfficacy Supplement with Clinical Data to Support
Tamifluoseltamivir phosphateCapsule;OralRocheLabeling Revision
Tamifluoseltamivir phosphateFor Suspension;OralRocheLabeling Revision
Technetium Tc 99m Generatortechnetium tc-99m sodium pertechnetate generatorSolution;Intravenous, OralGe HealthcareLabeling Revision

 

October 13, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdrenaclickepinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
Oxycontinoxycodone hydrochlorideTablet, Extended Release;OralPurdue Pharma LpManufacturing Change or Addition
Twinject 0.15epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
Twinject 0.3epinephrineInjectable;Intramuscular, SubcutaneousAmedra PharmsManufacturing Change or Addition
Valchlormechlorethamine hydrochlorideGel;TopicalActelion Pharms LtdManufacturing Change or Addition

 

October 10, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Akynzeonetupitant; palonosetron hydrochlorideCapsule;OralHelsinn HlthcareApproval
Curosurfporactant alfaSuspension;IntratrachealChiesi Usa IncLabeling Revision
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapLabeling Revision
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapManufacturing Change or Addition
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapLabeling Revision
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapLabeling Revision
Eligardleuprolide acetateInjectable;SubcutaneousTolmar TherapLabeling Revision
Harvoniledipasvir; sofosbuvirTablet;OralGilead Sciences IncApproval
Isentressraltegravir potassiumTablet;OralMerck Sharp DohmeManufacturing Change or Addition
Lumasonsulfur hexafluoride lipid-type a microspheresSuspension;InjectableBraccoApproval
Naftinnaftifine hydrochlorideCream;TopicalMerz PharmsEfficacy Supplement with Clinical Data to Support
Naftinnaftifine hydrochlorideGel;TopicalMerz PharmsSupplement
Prozacfluoxetine hydrochlorideCapsule;OralEli Lilly and CoEfficacy Supplement with Clinical Data to Support
Sarafemfluoxetine hydrochlorideCapsule;OralEli Lilly and CoEfficacy Supplement with Clinical Data to Support
SoliriseculizumabInjectable; Iv (Infusion)Alexion PharmSupplement
Symbyaxfluoxetine hydrochloride; olanzapineCapsule;OralLillyEfficacy Supplement with Clinical Data to Support
Verelan Pmverapamil hydrochlorideCapsule, Extended Release;OralAlkermes GainesvilleLabeling Revision

 

October 9, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Pegintronpeginterferon alfa-2bSyringeScheringApproval
Pegintronpeginterferon alfa-2bVialScheringApproval
Sylatronpeginterferon alfa-2bVialScheringApproval
Verelanverapamil hydrochlorideCapsule, Extended Release;OralAlkermes GainesvilleLabeling Revision

 

October 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
EuraxcrotamitonLotion;TopicalRanbaxyManufacturing Change or Addition
Olopatadine Hydrochlorideolopatadine hydrochlorideSolution;NasalApotex IncApproval
OtrexupmethotrexateSolution;SubcutaneousAntares Pharma IncManufacturing Change or Addition
Tamifluoseltamivir phosphateCapsule;OralRocheManufacturing Change or Addition
VelcadebortezomibInjectable;Intravenous, SubcutaneousMillennium PharmsEfficacy Supplement with Clinical Data to Support

 

October 7, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ambienzolpidem tartrateTablet;OralSanofi Aventis UsLabeling Revision
Ambien Crzolpidem tartrateTablet, Extended Release;OralSanofi Aventis UsLabeling Revision
Benicarolmesartan medoxomilTablet;OralDaiichi SankyoManufacturing Change or Addition
BudesonidebudesonideSolution;Topical FoamSalix PharmsApproval
Darunavir Ethanolatedarunavir ethanolateTablet;OralHetero Labs Unit IiiTentative Approval
Lo Minastrin Feethinyl estradiol; norethindrone acetateTablet, Chewable, Tablet;OralWarner ChilcottManufacturing Change or Addition
OtrexupmethotrexateSolution;SubcutaneousAntares Pharma IncManufacturing Change or Addition
ToriseltemsirolimusSolution;IntravenousPf Prism CvLabeling Revision
Zoladexgoserelin acetateImplant;ImplantationAstrazenecaLabeling Revision
Zoladexgoserelin acetateImplant;ImplantationAstrazenecaLabeling Revision

 

October 6, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Calcium Acetatecalcium acetateCapsule;OralAmneal PharmsApproval
EyleaafliberceptInjectable; InjectionRegeneron PharmaceuticalsEfficacy Supplement with Clinical Data to Support
Orenitramtreprostinil diolamineTablet, Extended Release;OralUnited TherapManufacturing Change or Addition

 

October 3, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Cortifoamhydrocortisone acetateAerosol, Metered;RectalMeda PharmsManufacturing Change or Addition
Flo-Predprednisolone acetateSuspension;OralTaroManufacturing Change or Addition
Nexium 24hresomeprazole magnesiumCapsule, Delayed Release;OralAstrazeneca LpLabeling Revision

 

October 2, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdenosineadenosineInjectable; InjectionAkorn IncApproval
HetlioztasimelteonCapsule;OralVanda Pharms IncApproval
Monoketisosorbide mononitrateTablet;OralKremers Urban PharmsLabeling Revision
Nitro-DurnitroglycerinFilm, Extended Release;TransdermalMerck Sharp DohmeLabeling Revision
Nitroglycerin In Dextrose 5%nitroglycerinInjectable;InjectionBaxter HlthcareLabeling Revision
PitocinoxytocinInjectable;InjectionPar Sterile ProductsLabeling Revision

October 1, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
FurosemidefurosemideTablet;OralDava Pharms IncLabeling Revision
Mirceramethoxy polyethylene glycol-epoetin betaSolution; InjectionHoffman-La RocheLabeling Revision

September 30, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmoxilamoxicillinTablet;OralDr Reddys Labs IncManufacturing Change or Addition
AmpyradalfampridineTablet, Extended Release;OralAcordaManufacturing Change or Addition
Augmentin '125'amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '200'amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '250'amoxicillin; clavulanate potassiumTablet;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '250'amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '400'amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '500'amoxicillin; clavulanate potassiumTablet;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin '875'amoxicillin; clavulanate potassiumTablet;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin Es-600amoxicillin; clavulanate potassiumFor Suspension;OralDr Reddys Labs IncManufacturing Change or Addition
Augmentin Xramoxicillin; clavulanate potassiumTablet, Extended Release;OralDr Reddys Labs IncManufacturing Change or Addition
AzactamaztreonamInjectable;InjectionBristol Myers SquibbManufacturing Change or Addition
Bloxiverzneostigmine methylsulfateSolution;IntravenousEclat Pharms LlcManufacturing Change or Addition
Brintellixvortioxetine hydrobromideTablet;OralTakeda Pharms UsaManufacturing Change or Addition
Cambiadiclofenac potassiumFor Solution;OralDepomed IncManufacturing Change or Addition
Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
ClozarilclozapineTablet;OralNovartisManufacturing Change or Addition
Dianeal 137 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal 137 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal 137 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Low Calcium W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Low Calcium W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Low Calcium W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Low Calcium W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-1 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 1.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 2.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 3.5% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
Dianeal Pd-2 W/ Dextrose 4.25% In Plastic Containercalcium chloride; dextrose; magnesium chloride; sodium chloride; sodium lactateSolution;IntraperitonealBaxter HlthcareManufacturing Change or Addition
DifferinadapaleneLotion;TopicalGalderma Labs LpManufacturing Change or Addition
Frovafrovatriptan succinateTablet;OralEndo PharmsManufacturing Change or Addition
Guanidine Hydrochlorideguanidine hydrochlorideTablet;OralMerck Sharp DohmeManufacturing Change or Addition
HumiraadalimumabSyringeAbbvie IncEfficacy Supplement with Clinical Data to Support
HumiraadalimumabVialAbbvie IncEfficacy Supplement with Clinical Data to Support
Humulin Ninsulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Hyzaarhydrochlorothiazide; losartan potassiumTablet;OralMerck Sharp DohmeLabeling Revision
Invanzertapenem sodiumInjectable;Intramuscular, Iv (Infusion)Merck Sharp DohmeLabeling Revision
K-Tabpotassium chlorideTablet, Extended Release;OralAbbvieManufacturing Change or Addition
Lactated Ringer's and Dextrose 5% In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateSolution;IrrigationBaxter HlthcareManufacturing Change or Addition
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateSolution;IrrigationBaxter HlthcareManufacturing Change or Addition
Lazandafentanyl citrateSpray, Metered;NasalDepomed IncManufacturing Change or Addition
Mestinonpyridostigmine bromideSyrup;OralValeant Pharm NorthManufacturing Change or Addition
NortheradroxidopaCapsule;OralLundbeck Na LtdManufacturing Change or Addition
NulojixbelataceptInjectable; InjectionBristol Myers SquibbLabeling Revision
Omega-3-Acid Ethyl Estersomega-3-acid ethyl estersCapsule;OralApotex IncApproval
Potassium Chloridepotassium chlorideTablet, Extended Release;OralAbbvieManufacturing Change or Addition
Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
PrometriumprogesteroneCapsule;OralAbbvie IncManufacturing Change or Addition
PrometriumprogesteroneCapsule; OralAbbvie IncManufacturing Change or Addition
Pyridostigmine Bromidepyridostigmine bromideTablet;OralUs ArmyManufacturing Change or Addition
RaltegravirraltegravirTablet;OralHetero Labs Ltd IiiTentative Approval
RemeronmirtazapineTablet;OralOrganon Usa IncManufacturing Change or Addition
Remeron SoltabmirtazapineTablet, Orally Disintegrating;OralOrganon Usa IncManufacturing Change or Addition
Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chlorideSolution;IrrigationBaxter HlthcareManufacturing Change or Addition
Saizensomatropin recombinantInjectable;InjectionEmd SeronoManufacturing Change or Addition
Serostimsomatropin recombinantInjectable;InjectionEmd SeronoManufacturing Change or Addition
Serostim Lqsomatropin recombinantInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Surmontiltrimipramine maleateCapsule;OralOdyssey PharmsManufacturing Change or Addition
TasmartolcaponeTablet;OralValeant Pharms LlcManufacturing Change or Addition
Tobi PodhalertobramycinPowder;InhalationNovartisManufacturing Change or Addition
Ultresapancrelipase (amylase;lipase;protease)Capsule, Delayed Release;OralForest Labs IncManufacturing Change or Addition
Vytorinezetimibe; simvastatinTablet;OralMsd IntlLabeling Revision
Yasmindrospirenone; ethinyl estradiolTablet;Oral-28Bayer HlthcareManufacturing Change or Addition
Yazdrospirenone; ethinyl estradiolTablet;OralBayer HlthcareManufacturing Change or Addition
ZetiaezetimibeTablet;OralMsd Intl GmbhLabeling Revision
ZyprexaolanzapineInjectable;IntramuscularLillyManufacturing Change or Addition

September 29, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abilify Maintena KitaripiprazoleFor Suspension, Extended Release;IntramuscularOtsuka Pharm Co LtdManufacturing Change or Addition
AlinianitazoxanideFor Suspension;OralRomarkManufacturing Change or Addition
ClozarilclozapineTablet;OralNovartisLabeling Revision
CortrosyncosyntropinInjectable;InjectionAmphastar Pharms IncManufacturing Change or Addition
Cozaarlosartan potassiumTablet;OralMerck Sharp DohmeLabeling Revision
Dextrose 5% In Plastic ContainerdextroseInjectable;InjectionB BraunManufacturing Change or Addition
Flo-Predprednisolone acetateSuspension;OralTaroManufacturing Change or Addition
Fludarabine Phosphatefludarabine phosphateInjectable;InjectionSandozManufacturing Change or Addition
Hyzaarhydrochlorothiazide; losartan potassiumTablet;OralMerck Sharp DohmeLabeling Revision
LumiganbimatoprostSolution/Drops;OphthalmicAllerganLabeling Revision
LumiganbimatoprostSolution/Drops;OphthalmicAllerganLabeling Revision
Nexteroneamiodarone hydrochlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Relistormethylnaltrexone bromideInjectable;SubcutaneousSalix PharmsEfficacy Supplement with Clinical Data to Support
Relistormethylnaltrexone bromideSolution;SubcutaneousSalix PharmsEfficacy Supplement with Clinical Data to Support
SkelaxinmetaxaloneTablet;OralKing PharmsManufacturing Change or Addition
Sodium Chloride 0.9% In Sterile Plastic Containersodium chlorideSolution For Slush;IrrigationBaxter HlthcareManufacturing Change or Addition
VersaclozclozapineSuspension;OralJazz Pharms IiiManufacturing Change or Addition
Voltarendiclofenac sodiumGel;TopicalNovartisManufacturing Change or Addition
Zingolidocaine hydrochlorideSystem;IntradermalPowder PharmsManufacturing Change or Addition
ZoviraxacyclovirOintment;TopicalValeant BermudaManufacturing Change or Addition

September 26, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Acetic Acid 0.25% In Plastic Containeracetic acid, glacialSolution;Irrigation, UrethralBaxter HlthcareManufacturing Change or Addition
AllopurinolallopurinolTablet;OralWatson LabsManufacturing Change or Addition
Aminoacetic Acid 1.5% In Plastic ContainerglycineSolution;IrrigationBaxter HlthcareManufacturing Change or Addition
CubicindaptomycinInjectable;Iv (Infusion)CubistManufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.2% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.33% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 15meq In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 20meq (K) In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5%, Sodium Chloride 0.45% and Potassium Chloride 5meq In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Diclofenac Sodiumdiclofenac sodiumSpray;TopicalWatson LabsTentative Approval
DiovanvalsartanTablet;OralNovartisLabeling Revision
ElidelpimecrolimusCream;TopicalValeant BermudaManufacturing Change or Addition
Firmagondegarelix acetatePowder;SubcutaneousFerringManufacturing Change or Addition
Hiconsodium iodide i-131Solution;OralJubilant DraximageManufacturing Change or Addition
Iluvienfluocinolone acetonideInsert;IntravitrealAlimera Sciences IncApproval
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateSolution;IrrigationBaxter HlthcareManufacturing Change or Addition
LetairisambrisentanTablet;OralGileadManufacturing Change or Addition
Linezolidlinezolid sodium chlorideInjectable;InjectionHospira IncTentative Approval
Loestrin 21 1.5/30ethinyl estradiol; norethindrone acetateTablet;Oral-21Warner Chilcott LlcManufacturing Change or Addition
Loestrin 21 1/20ethinyl estradiol; norethindrone acetateTablet;Oral-21Warner Chilcott LlcManufacturing Change or Addition
Loestrin Fe 1/20ethinyl estradiol; norethindrone acetateTablet;Oral-28Warner ChilcottManufacturing Change or Addition
Mekinisttrametinib dimethyl sulfoxideTablet;OralGlaxosmithkline LlcManufacturing Change or Addition
MitigarecolchicineCapsule;OralHikma Pharms LlcApproval
Namenda Xrmemantine hydrochlorideCapsule, Extended Release;OralForest LabsLabeling Revision
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Protonix Ivpantoprazole sodiumInjectable;Iv (Infusion)Wyeth Pharms IncManufacturing Change or Addition
Qsymiaphentermine hydrochloride; topiramateCapsule, Extended Release;OralVivusLabeling Revision
Qsymiaphentermine hydrochloride; topiramateCapsule, Extended Release;OralVivusSupplement
Sodium Iodide I-131sodium iodide i-131Capsule;OralJubilant DraximageManufacturing Change or Addition
Sterile Water For Injection In Plastic Containersterile water for injectionLiquid;N/ABaxter HlthcareManufacturing Change or Addition
Sterile Water In Plastic Containersterile water for irrigationLiquid;IrrigationBaxter HlthcareManufacturing Change or Addition
Tagamet HbcimetidineTablet;OralMedtech ProdsManufacturing Change or Addition
XolairomalizumabVialGenentechEfficacy Supplement with Clinical Data to Support
Zenpeppancrelipase (amylase;lipase;protease)Capsule, Delayed Release;OralForest Labs IncManufacturing Change or Addition
Zutriprochlorpheniramine maleate; hydrocodone bitartrate; pseudoephedrine hydrochlorideSolution;OralCypress PharmManufacturing Change or Addition
Zyrtec Allergycetirizine hydrochlorideTablet;OralMcneil ConsumerManufacturing Change or Addition
Zyrtec Hives Reliefcetirizine hydrochlorideTablet;OralMcneil ConsumerManufacturing Change or Addition

September 25, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Abacavir Sulfate; Lamivudineabacavir sulfate;lamivudineTablet;OralHetero Labs Ltd VTentative Approval
Betopticbetaxolol hydrochlorideSolution/Drops;OphthalmicAlconManufacturing Change or Addition
Brovanaarformoterol tartrateSolution;InhalationSunovionManufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.075% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.15% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.224% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Dextrose 5% and Potassium Chloride 0.3% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Fludeoxyglucose F 18fludeoxyglucose f 18Injectable;InjectionMassachusetts General HospApproval
Genotropinsomatropin recombinantInjectable;InjectionPharmacia and UpjohnLabeling Revision
Genotropin Preservative Freesomatropin recombinantInjectable;InjectionPharmacia and UpjohnLabeling Revision
Minocycline Hydrochlorideminocycline hydrochlorideTablet, Extended Release;OralRanbaxy Labs LtdApproval
MitosolmitomycinFor Solution;TopicalMobius TherapLabeling Revision
Norditropinsomatropin recombinantInjectable;InjectionNovo Nordisk IncLabeling Revision
Norditropin Flexprosomatropin recombinantInjectable;InjectionNovo Nordisk IncLabeling Revision
Norditropin Nordiflexsomatropin recombinantInjectable;InjectionNovo Nordisk IncLabeling Revision
Phentermine Hydrochloridephentermine hydrochlorideTablet;OralKen LifescienceApproval
Phentermine Hydrochloridephentermine hydrochlorideCapsule;OralKen LifescienceApproval
Premarinestrogens, conjugatedCream;Topical, VaginalWyeth Pharms IncManufacturing Change or Addition
Qolianabrimonidine tartrateSolution/Drops;OphthalmicAlcon Pharms LtdManufacturing Change or Addition
Tasignanilotinib hydrochloride monohydrateCapsule;OralNovartisLabeling Revision
Timolol Maleatetimolol maleateSolution, Gel Forming/Drops;OphthalmicFalcon PharmsManufacturing Change or Addition
UcerisbudesonideTablet, Extended Release;OralSantarus IncManufacturing Change or Addition
Zinacefcefuroxime sodiumInjectable;InjectionCovis InjectablesLabeling Revision
Zinacefcefuroxime sodiumInjectable;Intramuscular, IntravenousCovis InjectablesLabeling Revision
Zinacef In Plastic Containercefuroxime sodiumInjectable;InjectionCovis InjectablesLabeling Revision

September 24, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
ArmodafinilarmodafinilTablet;OralTeva Pharms Usa IncTentative Approval
BenzonatatebenzonatateCapsule;OralThepharmanetwork LlcApproval
DiovanvalsartanCapsule;OralNovartisLabeling Revision
Diovan Hcthydrochlorothiazide; valsartanTablet;OralNovartisLabeling Revision
Exforgeamlodipine besylate; valsartanTablet;OralNovartisLabeling Revision
Exforge Hctamlodipine besylate; hydrochlorothiazide; valsartanTablet;OralNovartisLabeling Revision
FortazceftazidimeInjectable;InjectionCovis InjectablesLabeling Revision
Fortaz In Plastic Containerceftazidime sodiumInjectable;InjectionCovis InjectablesLabeling Revision
Fosrenollanthanum carbonateTablet, Chewable;OralShire LlcLabeling Revision
Fosrenollanthanum carbonatePowder;OralShire DevelopmentLabeling Revision
Naftinnaftifine hydrochlorideGel;TopicalMerz PharmsManufacturing Change or Addition
Raloxifene Hydrochlorideraloxifene hydrochlorideTablet; OralInvagen PharmsApproval
Spiriva Respimattiotropium bromideSpray, Metered;InhalationBoehringer IngelheimApproval
Sterile Water In Plastic Containersterile water for irrigationLiquid;IrrigationHospiraManufacturing Change or Addition
TybostcobicistatTablet;OralGilead Sciences IncEfficacy Supplement with Clinical Data to Support
Velphorosucroferric oxyhydroxideTablet, Chewable;OralVifor FreseniusLabeling Revision
Vibramycindoxycycline hyclateInjectable;InjectionPfizerLabeling Revision
VitektaelvitegravirTablet;OralGilead Sciences IncApproval
Xylocaine Viscouslidocaine hydrochlorideSolution;OralFresenius Kabi UsaLabeling Revision

September 23, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Azoramlodipine besylate; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Benicarolmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
Benicar Hcthydrochlorothiazide; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
HumiraadalimumabSyringeAbbvie IncEfficacy Supplement with Clinical Data to Support
HumiraadalimumabVialAbbvie IncEfficacy Supplement with Clinical Data to Support
Humulin Rinsulin recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin R Peninsulin recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Methylphenidate Hydrochloridemethylphenidate hydrochlorideTablet;OralVintage PharmsApproval
MinivelleestradiolFilm, Extended Release;TransdermalNovenEfficacy Supplement with Clinical Data to Support
Opana ERoxymorphone hydrochlorideTablet, Extended Release;OralEndo PharmsManufacturing Change or Addition
OtezlaapremilastTablet;OralCelgene CorpApproval
Ropivacaine Hydrochlorideropivacaine hydrochlorideInjectable;InjectionHospira IncApproval
Ropivacaine Hydrochlorideropivacaine hydrochlorideInjectable; InjectionSagent PharmsApproval
Topotecan Hydrochloridetopotecan hydrochlorideSolution;IntravenousTeva Pharms UsaManufacturing Change or Addition
Tribenzoramlodipine besylate; hydrochlorothiazide; olmesartan medoxomilTablet;OralDaiichi SankyoLabeling Revision
ZanosarstreptozocinInjectable;InjectionTeva Pharms UsaManufacturing Change or Addition
ZelborafvemurafenibTablet;OralHoffmann La RocheManufacturing Change or Addition

 

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

September 20, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ceftin cefuroxime axetilTablet;OralGlaxosmithklineLabeling Revision
Ceftincefuroxime axetilFor Suspension;OralGlaxosmithklineLabeling Revision

September 19, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ammonia N 13 Injectionammonia n 13 injectionInjectable;InjectionShertech Labs LlcApproval
Chantixvarenicline tartrateTablet;OralPfizer IncEfficacy Supplement with Clinical Data to Support
Chantixvarenicline tartrateTablet;OralPfizer IncLabeling Revision
Janumet Xrmetformin hydrochloride; sitagliptin phosphateTablet, Extended Release;OralMerck Sharp DohmeManufacturing Change or Addition
LexiscanregadenosonSolution;IntravenousAstellasLabeling Revision
LumiganbimatoprostSolution/Drops;OphthalmicAllerganManufacturing Change or Addition
Marcainebupivacaine hydrochlorideInjectable;SpinalHospiraManufacturing Change or Addition
Marcaine Hydrochloridebupivacaine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride Preservative Freebupivacaine hydrochlorideInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrinebupivacaine hydrochloride; epinephrine bitartrateInjectable;InjectionHospiraManufacturing Change or Addition
Marcaine Hydrochloride W/ Epinephrine Preservative Freebupivacaine hydrochloride; epinephrine bitartrateInjectable;InjectionHospiraManufacturing Change or Addition
Nasacort Allergy 24 Hourtriamcinolone acetonideSpray, Metered;NasalSanofi Aventis UsLabeling Revision
OtezlaapremilastTablet;OralCelgene CorpManufacturing Change or Addition
PentostatinpentostatinInjectable;InjectionMylan InstitutionalApproval
Rizatriptan Benzoaterizatriptan benzoateTablet, Orally Disintegrating;OralMacleods Pharms LtdApproval
TemodartemozolomideCapsule;OralMerck Sharp DohmeManufacturing Change or Addition

September 18, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Aloxipalonosetron hydrochlorideInjectable;IntravenousHelsinn HlthcareLabeling Revision
Aloxipalonosetron hydrochlorideCapsule;OralHelsinn HlthcareLabeling Revision
Anzemetdolasetron mesylateTablet;OralSanofi Aventis UsLabeling Revision
Anzemetdolasetron mesylateInjectable;InjectionSanofi Aventis UsLabeling Revision
BiltricidepraziquantelTablet;OralBayer HlthcareManufacturing Change or Addition
Cefazolin and Dextrosecefazolin sodiumInjectable;InjectionB BraunEfficacy Supplement with Clinical Data to Support
Cleocin Phosphate In Dextrose 5% In Plastic Containerclindamycin phosphateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
HalciontriazolamTablet;OralPharmacia and UpjohnLabeling Revision
Hydralazine Hydrochloridehydralazine hydrochlorideTablet;OralCadila Pharms LtdApproval
Megace Esmegestrol acetateSuspension;OralPar PharmLabeling Revision
OfloxacinofloxacinTablet;OralCadila Pharms LtdApproval
SancusogranisetronFilm, Extended Release;TransdermalProstrakan IncLabeling Revision
TrulicitydulaglutideInjectable;InjectionEli Lilly and CoApproval
VasostrictvasopressinSolution;Iv (Infusion)Par Sterile ProductsManufacturing Change or Addition
Zofranondansetron hydrochlorideInjectable;InjectionGlaxosmithklineLabeling Revision
Zofranondansetron hydrochlorideTablet;OralGlaxosmithklineLabeling Revision
Zofranondansetron hydrochlorideSolution;OralGlaxosmithklineLabeling Revision
Zofran OdtondansetronTablet, Orally Disintegrating;OralGlaxosmithklineLabeling Revision
Zofran Preservative Freeondansetron hydrochlorideInjectable;InjectionGlaxosmithklineLabeling Revision
ZuplenzondansetronFilm;OralGalena Biopharma IncLabeling Revision

September 17, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AmoxapineamoxapineTablet;OralWatson LabsLabeling Revision
Citalopram Hydrobromidecitalopram hydrobromideSolution;OralRoxaneLabeling Revision
DaliresproflumilastTablet;OralForest Res Inst IncManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
DocetaxeldocetaxelInjectable;InjectionActavis IncLabeling Revision
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Serostimsomatropin recombinantInjectable;InjectionEmd SeronoManufacturing Change or Addition
Serostim Lqsomatropin recombinantInjectable;SubcutaneousEmd SeronoManufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
StendraavanafilTablet;OralVivusEfficacy Supplement with Clinical Data to Support
Tofranilimipramine hydrochlorideTablet;OralMallinckrodt IncLabeling Revision
Venlafaxine Hydrochloridevenlafaxine hydrochlorideTablet;OralTevaLabeling Revision
Vivactilprotriptyline hydrochlorideTablet;OralOdyssey PharmsLabeling Revision

September 16, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Ambisomeamphotericin bInjectable, Liposomal;InjectionAstellasManufacturing Change or Addition
Compleraemtricitabine; rilpivirine hydrochloride; tenofovir disoproxil fumarateTablet;OralGilead Sciences IncLabeling Revision
Forticalcalcitonin salmon recombinantSpray, Metered;NasalUpsher SmithManufacturing Change or Addition
MovantiknaloxegolTablet, Tablet;OralAstrazeneca PharmsApproval
TegretolcarbamazepineTablet;OralNovartisLabeling Revision
TegretolcarbamazepineTablet, Chewable;OralNovartisLabeling Revision
TegretolcarbamazepineSuspension;OralNovartisLabeling Revision
Tegretol-XrcarbamazepineTablet, Extended Release;OralNovartisLabeling Revision
Tobramycin Sulfatetobramycin sulfateInjectable;InjectionAkornApproval
Tobramycin Sulfatetobramycin sulfateInjectable;InjectionXellia Pharms ApsApproval
VarithenapolidocanolSolution;IntravenousProvensisManufacturing Change or Addition

September 15, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
AdenosineadenosineInjectable; InjectionEmcure Pharms LtdApproval
Aminosyn Ii 10% In Plastic Containeramino acidsInjectable;InjectionHospiraManufacturing Change or Addition
AmoxicillinamoxicillinSuspension;OralAurobindo Pharma LtdApproval
BudesonidebudesonideSolution;Topical FoamSalix PharmsTentative Approval
CentanymupirocinOintment;TopicalPerrigo New YorkManufacturing Change or Addition
Clinimix 2.75/10 Sulfite Free In Dextrose 10% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 2.75/25 Sulfite Free In Dextrose 25% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 2.75/5 Sulfite Free In Dextrose 5% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 4.25/10 Sulfite Free In Dextrose 10% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 4.25/20 Sulfite Free In Dextrose 20% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 4.25/25 Sulfite Free In Dextrose 25% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 4.25/5 Sulfite Free In Dextrose 5% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 5/10 Sulfite Free In Dextrose 10% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 5/15 Sulfite Free In Dextrose 15% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 5/20 Sulfite Free In Dextrose 20% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 5/25 Sulfite Free In Dextrose 25% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix 5/35 Sulfite Free In Dextrose 35% In Plastic Containeramino acids; dextroseInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 2.75/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/20 Sulfite-Free W/ Elect In Dextrose 20% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 4.25/5 Sulfite-Free W/ Elect In Dextrose 5% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/10 Sulfite-Free W/ Elect In Dextrose 10% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/15 Sulfite-Free W/ Elect In Dextrose 15% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/20 Sulfite-Free W/ Elect In 20% Dextrose W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/25 Sulfite-Free W/ Elect In Dextrose 25% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Clinimix E 5/35 Sulfite-Free W/ Elect In Dextrose 35% W/ Calcium In Plastic Containeramino acids; calcium chloride; dextrose; magnesium chloride; potassium phosphate, dibasic; sodium acetate; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
ClopidogrelclopidogrelTablet;OralSciegen Pharms IncApproval
GlipizideglipizideTablet, Extended Release;OralZydus Pharms Usa IncTentative Approval
Membranebluetrypan blueSolution;OphthalmicDorcLabeling Revision
Methylinmethylphenidate hydrochlorideSolution;OralMallinckrodtManufacturing Change or Addition
Methylinmethylphenidate hydrochlorideTablet, Chewable;OralMallinckrodtManufacturing Change or Addition
Setlakinethinyl estradiol; levonorgestrelTablet;OralNovast Labs LtdApproval
Travasol 10% In Plastic Containeramino acidsInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Travasol 5.5% In Plastic Containeramino acidsInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Travasol 8.5% In Plastic Containeramino acidsInjectable;InjectionBaxter HlthcareManufacturing Change or Addition

September 12, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Advil Liqui-GelsibuprofenCapsule;OralPfizerManufacturing Change or Addition
Advil Migraine Liqui-GelsibuprofenCapsule;OralPfizerManufacturing Change or Addition
AfinitoreverolimusTablet;OralNovartisManufacturing Change or Addition
Allegra Allergyfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Allegra Hivesfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Amlodipine and Valsartanamlodipine;valsartanTablet;OralTorrent Pharms LtdTentative Approval
An-Sulfur Colloidtechnetium tc-99m sulfur colloid kitSolution;Injection, OralPharmalucenceManufacturing Change or Addition
Children's Allegra Allergyfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Children's Allegra Hivesfexofenadine hydrochlorideTablet;OralSanofi Aventis UsLabeling Revision
Clindamycin Phosphate and Benzoyl Peroxidebenzoyl peroxide; clindamycin phosphateGel;TopicalMylan Pharms IncManufacturing Change or Addition
DaptomycindaptomycinInjectable;InjectionHospira IncApproval
Emtricitabine;Tenofovir Disoproxil Fumarate;Nevirapineemtricitabine;tenofovir disoproxil fumarate;nevirapineTablet;OralMylan Labs LtdTentative Approval
Forteoteriparatide recombinant humanInjectable;SubcutaneousLillyManufacturing Change or Addition
Glycine 1.5% In Plastic ContainerglycineSolution;IrrigationB BraunManufacturing Change or Addition
Humaloginsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Kwikpeninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50insulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50 Kwikpeninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 50/50 Peninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25insulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25 Kwikpeninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Mix 75/25 Peninsulin lispro protamine recombinant; insulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humalog Peninsulin lispro recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humatropesomatropin recombinantInjectable;InjectionLillyManufacturing Change or Addition
Humulin 70/30insulin recombinant human; insulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin 70/30 Peninsulin recombinant human; insulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Humulin Ninsulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
Mycophenolate Mofetilmycophenolate mofetilCapsule;OralRoxaneManufacturing Change or Addition
Mycophenolate Mofetilmycophenolate mofetilTablet;OralRoxaneManufacturing Change or Addition
Naprelannaproxen sodiumTablet, Extended Release;OralAlmatica Pharma IncManufacturing Change or Addition
PomalystpomalidomideCapsule;OralCelgeneLabeling Revision
RevlimidlenalidomideCapsule;OralCelgeneLabeling Revision
ThalomidthalidomideCapsule;OralCelgeneSupplement
Vibra-Tabsdoxycycline hyclateTablet;OralPfizerLabeling Revision
VibramycindoxycyclineFor Suspension;OralPfizerLabeling Revision
Vibramycindoxycycline hyclateCapsule;OralPfizerLabeling Revision
Vibramycindoxycycline calciumSuspension;OralPfizerLabeling Revision
Zoloftsertraline hydrochlorideTablet;OralPfizerLabeling Revision
Zoloftsertraline hydrochlorideConcentrate;OralPfizerLabeling Revision

September 11, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Argatroban In Sodium ChlorideargatrobanInjectable;Iv (Infusion)SandozManufacturing Change or Addition
Dorzolamide Hydrochloridedorzolamide hydrochlorideSolution;OphthalmicWatson Labs IncApproval
HectoroldoxercalciferolInjectable;InjectionGenzyme CorpManufacturing Change or Addition
Levalbuterol Hydrochloridelevalbuterol hydrochlorideSolution;InhalationTeva ParenteralApproval
MicronornorethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Modicon 28ethinyl estradiol; norethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Montelukast Sodiummontelukast sodiumTablet;OralMacleods Pharms LtdApproval
Opcicon One-SteplevonorgestrelTablet;OralSun Pharm IndsApproval
Ortho-Novum 1/35-28ethinyl estradiol; norethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition
Ortho-Novum 7/7/7-21ethinyl estradiol; norethindroneTablet;Oral-21Janssen PharmsManufacturing Change or Addition
Ortho-Novum 7/7/7-28ethinyl estradiol; norethindroneTablet;Oral-28Janssen PharmsManufacturing Change or Addition

September 10, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Contravenaltrexone hydrochloride;bupropion hydrochlorideTablet, Extended Release;OralOrexigen Therapeutics IncApproval
EmsamselegilineFilm, Extended Release;TransdermalSomersetEfficacy Supplement with Clinical Data to Support
EmsamselegilineFilm, Extended Release;TransdermalSomersetLabeling Revision
EmsamselegilineSystem; TransdermalSomersetApproval
FamciclovirfamciclovirTablet;OralHetero Labs Ltd VApproval
Montelukast Sodiummontelukast sodiumTablet;OralHetero Drugs LtdApproval
MucinexguaifenesinTablet, Extended Release;OralReckitt BenckiserManufacturing Change or Addition
Oxycodone Hydrochlorideoxycodone hydrochlorideSolution;OralLannett Holdings IncApproval
OxytocinoxytocinInjectable;InjectionFresenius Kabi UsaManufacturing Change or Addition
Pantoprazole Sodiumpantoprazole sodiumTablet, Delayed Release;OralHetero Labs Ltd VApproval
XtandienzalutamideCapsule;OralAstellasEfficacy Supplement with Clinical Data to Support

September 9, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Argatroban In Sodium ChlorideargatrobanInjectable;Iv (Infusion)Eagle PharmsLabeling Revision
Iclusigponatinib hydrochlorideTablet;OralAriadManufacturing Change or Addition
Levocetirizine Dihydrochloridelevocetirizine dihydrochlorideTablet;OralSciegen Pharms IncApproval
Namenda Xrmemantine hydrochlorideCapsule, Extended Release;OralForest LabsManufacturing Change or Addition
TacrolimustacrolimusOintment;TopicalFougera Pharms IncApproval
Ultratagtechnetium tc-99m red blood cell kitInjectable;InjectionMallinckrodtManufacturing Change or Addition
Unithroidlevothyroxine sodiumTablet;OralStevens JManufacturing Change or Addition

September 8, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Bonivaibandronate sodiumInjectable;IntravenousRocheManufacturing Change or Addition
Brintellixvortioxetine hydrobromideTablet;OralTakeda Pharms UsaManufacturing Change or Addition
Buprenorphine and Naloxonebuprenorphine hydrocloride; naloxone hydrochlorideTablet;SublingualTeva Pharms UsaApproval
Dextrose 10% In Plastic ContainerdextroseInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
KalbitorecallantideInjectable; InjectionDyax Corp.Labeling Revision
Lactated Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
NitrofurantoinnitrofurantoinSuspension;OralNovel Labs IncApproval
Normosol-M and Dextrose 5% In Plastic Containerdextrose; magnesium acetate; potassium acetate; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Ondansetron Hydrochlorideondansetron hydrochlorideInjectable;InjectionQilu Pharma Co LtdApproval
Potassium Chloride 10meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 10meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 15meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 20meq In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 30meq In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Dextrose 5% In Plastic Containerdextrose; potassium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Lactated Ringer's In Plastic Containercalcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactateInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.45% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Potassium Chloride 5meq In Dextrose 5% and Sodium Chloride 0.9% In Plastic Containerdextrose; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Ringer's In Plastic Containercalcium chloride; potassium chloride; sodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.45% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionHospiraManufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 3% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
Sodium Chloride 5% In Plastic Containersodium chlorideInjectable;InjectionB BraunManufacturing Change or Addition
VelcadebortezomibInjectable;Intravenous, SubcutaneousMillennium PharmsManufacturing Change or Addition

September 6, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Solu-Cortefhydrocortisone sodium succinateInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition

September 5, 2014

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Besivancebesifloxacin hydrochlorideSuspension/Drops;OphthalmicBausch and LombManufacturing Change or Addition
CampathalemtuzumabVial; IntravenousIlex PharmaceuticalsLabeling Revision
CerezymeimigluceraseInjectable;InjectionGenzymeManufacturing Change or Addition
Ferric Citrateferric citrateTablet;OralKeryx Biopharma IncApproval
Lantusinsulin glargine recombinantInjectable;InjectionSanofi Aventis UsManufacturing Change or Addition
Lantus Solostarinsulin glargine recombinantInjectable;InjectionSanofi Aventis UsManufacturing Change or Addition
Mirvasobrimonidine tartrateGel;TopicalGalderma Labs LpManufacturing Change or Addition
Mucinex Dmdextromethorphan hydrobromide; guaifenesinTablet, Extended Release;OralReckitt BenckiserManufacturing Change or Addition
Olysiosimeprevir sodiumCapsule;OralJanssen ProdsLabeling Revision
Pegasyspeginterferon alfa-2aSyringeHoffman-La RocheLabeling Revision
Pegasyspeginterferon alfa-2aVial; SubcutaneousHoffman-La RocheLabeling Revision

 

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