Mar 022016
 

March 2, 2016

Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type
Atnaa atropine; pralidoxime chloride Injectable;Intramuscular Us Army Manufacturing Change or Addition
Duodote atropine; pralidoxime chloride Injectable;Intramuscular Meridian Medcl Manufacturing Change or Addition
Eliquis apixaban Tablet;Oral Bristol Myers Squibb Supplement
Faslodex fulvestrant Injectable;Intramuscular Astrazeneca Efficacy Supplement with Clinical Data to Support
Foradil formoterol fumarate Powder;Inhalation Novartis Manufacturing Change or Addition
Kengreal cangrelor Powder;Iv (Infusion) The Medicines Co Manufacturing Change or Addition
Magnesium Sulfate In Dextrose 5% In Plastic Container magnesium sulfate Injectable;Injection Hq Spclt Pharma Approval
Nymalize nimodipine Solution;Oral Arbor Pharms Llc Manufacturing Change or Addition
Prolia denosumab Injectable; Subcutaneous Amgen Labeling Revision
Rhinocort budesonide Spray, Metered;Nasal Astrazeneca Pharms Manufacturing Change or Addition
Rhinocort Allergy budesonide Spray, Metered;Nasal Astrazeneca Pharms Manufacturing Change or Addition
Ritonavir ritonavir Tablet;Oral Mylan Pharms Inc Tentative Approval
Venofer iron sucrose Injectable;Intravenous Luitpold Manufacturing Change or Addition
Xgeva denosumab Injectable; Subcutaneous Amgen Labeling Revision