New and Generic Drug Approvals
Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Children's Zyrtec Allergy cetirizine hydrochloride Syrup;Oral Mcneil Consumer Labeling Revision Children's Zyrtec Hives Relief cetirizine hydrochloride Syrup;Oral Mcneil Consumer Labeling Revision Estring estradiol Insert, Extended Release;Vaginal Pharmacia and Upjohn Manufacturing Change or Addition Liptruzet atorvastatin calcium; ezetimibe Tablet;Oral Merck Sharp Dohme Manufacturing Change or Addition Mestinon pyridostigmine bromide Tablet;Oral Valeant Pharms Llc Manufacturing Change or Addition Oxytrol oxybutynin Film, Extended Release;Transdermal Watson Labs (Utah) Manufacturing Change or Addition Phoslyra calcium acetate Solution;Oral Fresenius Medcl Manufacturing Change or Addition