Mar 032016
 

March 3, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Almotriptan Malate almotriptan malate Tablet;Oral Ajanta Pharma Ltd Approval
Cerebyx fosphenytoin sodium Injectable;Injection Parke Davis Labeling Revision
Cerezyme imiglucerase Injectable;Injection Genzyme Manufacturing Change or Addition
Epi E Z Pen Jr epinephrine Injectable;Intramuscular Mylan Speclt Manufacturing Change or Addition
Epipen epinephrine Injectable;Intramuscular, Subcutaneous Mylan Speclt Manufacturing Change or Addition
Epipen E Z Pen epinephrine Injectable;Intramuscular Mylan Speclt Manufacturing Change or Addition
Epipen Jr. epinephrine Injectable;Intramuscular, Subcutaneous Mylan Speclt Manufacturing Change or Addition
Oxytrol For Women oxybutynin Film, Extended Release;Transdermal Allergan Sales Llc Labeling Revision
Proventil-Hfa albuterol sulfate Aerosol, Metered;Inhalation 3m Manufacturing Change or Addition
Sodium Chloride 0.9% In Plastic Container sodium chloride Injectable;Injection Baxter Hlthcare Manufacturing Change or Addition
Zarxio filgrastim-sndz Injectable;Injection Sandoz Inc Labeling Revision