New and Generic Drug Approvals

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January 12, 2015

 

Drug NameActive IngredientDosage Form/RouteSponsorSubmission Type
Activellaestradiol; norethindrone acetateTablet;OralAmneal Pharms LlcManufacturing Change or Addition
Atriplaefavirenz; emtricitabine; tenofovir disoproxil fumarateTablet;OralGileadManufacturing Change or Addition
Caverject ImpulsealprostadilInjectable;InjectionPharmacia and UpjohnManufacturing Change or Addition
CaystonaztreonamFor Solution;InhalationGileadManufacturing Change or Addition
Cleocin Tclindamycin phosphateGel;TopicalPharmacia and UpjohnManufacturing Change or Addition
Desogendesogestrel; ethinyl estradiolTablet;Oral-21Organon Usa IncManufacturing Change or Addition
Desogendesogestrel; ethinyl estradiolTablet;Oral-28Organon Usa IncManufacturing Change or Addition
DesonatedesonideGel;TopicalBayer HlthcareManufacturing Change or Addition
Dextrose 5% In Sodium Chloride 0.9% In Plastic Containerdextrose; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
EmendaprepitantCapsule;OralMerckManufacturing Change or Addition
Emendfosaprepitant dimegluminePowder;IntravenousMerck and Co IncManufacturing Change or Addition
Ganirelix Acetateganirelix acetateInjectable;InjectionOrganon Usa IncManufacturing Change or Addition
Humulin Ninsulin susp isophane recombinant humanInjectable;InjectionLillyManufacturing Change or Addition
MetrogelmetronidazoleGel;TopicalGalderma Labs LpManufacturing Change or Addition
MetrolotionmetronidazoleLotion;TopicalGalderma Labs LpLabeling Revision
Potassium Chloride 0.15% In Sodium Chloride 0.45% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 0.15% In Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 0.224% In Sodium Chloride 0.9%potassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Potassium Chloride 0.3% and Sodium Chloride 0.9% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Pregnylgonadotropin, chorionicInjectable;InjectionOrganon Usa IncManufacturing Change or Addition
Reglanmetoclopramide hydrochlorideTablet;OralAni PharmsManufacturing Change or Addition
Revatiosildenafil citrateFor Suspension;OralPfizerManufacturing Change or Addition
Sodium Chloride 0.9% and Potassium Chloride 0.075% In Plastic Containerpotassium chloride; sodium chlorideInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Sodium Lactate 0.167 Molar In Plastic Containersodium lactateInjectable;InjectionBaxter HlthcareManufacturing Change or Addition
Sodium Phosphates In Plastic Containersodium phosphate, dibasic, heptahydrate; sodium phosphate, monobasic, anhydrousInjectable;InjectionHospiraManufacturing Change or Addition
VagifemestradiolTablet;VaginalNovo Nordisk IncManufacturing Change or Addition
Ventolin Hfaalbuterol sulfateAerosol, Metered;InhalationGlaxosmithklineManufacturing Change or Addition

 


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