New and Generic Drug Approvals

Drug Name Active IngredientDosage Form/Route SponsorSubmission Type
Children's Zyrtec Allergy cetirizine hydrochlorideSyrup;Oral Mcneil ConsumerLabeling Revision
Children's Zyrtec Hives Relief cetirizine hydrochlorideSyrup;Oral Mcneil ConsumerLabeling Revision
Estring estradiolInsert, Extended Release;Vaginal Pharmacia and UpjohnManufacturing Change or Addition
Liptruzet atorvastatin calcium; ezetimibeTablet;Oral Merck Sharp DohmeManufacturing Change or Addition
Mestinon pyridostigmine bromideTablet;Oral Valeant Pharms LlcManufacturing Change or Addition
Oxytrol oxybutyninFilm, Extended Release;Transdermal Watson Labs (Utah)Manufacturing Change or Addition
Phoslyra calcium acetateSolution;Oral Fresenius MedclManufacturing Change or Addition

 

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