New & Generic Drug Approvals by US FDA -2014

By: Pharma News | Views: 2605 | Date: 23-Sep-2014

New and Generic Drug Approvals by US FDA -2014


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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