New and Generic Drug Approvals

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Atnaa atropine; pralidoxime chlorideInjectable;Intramuscular Us ArmyManufacturing Change or Addition
Claritin loratadineSyrup;Oral Schering PloughManufacturing Change or Addition
Claritin Hives Relief loratadineSyrup;Oral Schering PloughManufacturing Change or Addition
Desonide desonideCream;Topical Perrigo New YorkManufacturing Change or Addition
Invokana canagliflozinTablet;Oral Janssen PharmsLabeling Revision
Izba travoprostSolution;Ophthalmic Alcon Labs IncApproval
Lunesta eszopicloneTablet;Oral Sunovion Pharms IncLabeling Revision
Nutropin Aq somatropin recombinantInjectable;Injection GenentechManufacturing Change or Addition
Nutropin Aq Pen somatropin recombinantInjectable;Injection GenentechManufacturing Change or Addition
Olanzapine olanzapineTablet, Orally Disintegrating;Oral Aurobindo Pharma LtdApproval
Opana Er oxymorphone hydrochlorideTablet, Extended Release;Oral Endo PharmsManufacturing Change or Addition
Oxytrol For Women oxybutyninFilm, Extended Release;Transdermal Msd ConsumerManufacturing Change or Addition
Prilosec Otc omeprazole magnesiumTablet, Delayed Release;Oral AstrazenecaManufacturing Change or Addition
Taxotere docetaxelInjectable;Injection Sanofi Aventis UsManufacturing Change or Addition
Trivagizole 3 clotrimazoleCream;Vaginal TaroManufacturing Change or Addition
Xarelto rivaroxabanTablet; Oral Janssen PharmsManufacturing Change or Addition

 

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