Feb 222016
 

February 22, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Comtan entacapone Tablet;Oral Orion Pharma Labeling Revision
Dextrose 20% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 30% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 40% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 50% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Dextrose 70% In Plastic Container dextrose Injectable;Injection Hospira Labeling Revision
Morphine Sulfate morphine sulfate Solution;Oral Lannett Holdings Inc Manufacturing Change or Addition
Opana Er oxymorphone hydrochloride Tablet, Extended Release;Oral Endo Pharms Manufacturing Change or Addition
Opsumit macitentan Tablet;Oral Actelion Pharms Ltd Supplement
Simponi Aria golimumab Injectable; Injection Janssen Biotech Labeling Revision
Somavert pegvisomant Injectable;Subcutaneous Pharmacia and Upjohn Manufacturing Change or Addition