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Reconsider and Revoke the Orphan Drug Designation Granted to GeNO on June 18, 2012 for Nitric Oxide

Type: Non-Rule Making
KeyWord(s) 2012-9069, Ikaria Inc, INO, Therapeutics, NDA# 20-845, INOmax, nitric oxide, 800 ppm, 100 ppm, inhalation, GeNO, Orphan Drug, persistent pulmonary hypertension, newborns, Hypoxic Respiratory Failure, lungs, Clinical Trials, open, oc
Short title Reconsider and Revoke the Orphan Drug Designation Granted to GeNO
Docket Item Code P
Center OC

Primary Documents (7)