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 |