Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

FDA Approval Activities for this Drug… Infasurf (calfactant) Intratracheal Suspension, ONY NDA 20-521 7/1/1998 7/2/98 7/2/98 4/11/02 Infasurf Indication: for the prevention and treatment of Respiratory Distress Syndrome (RDS) in neonates.   For the latest approval information, locate this drug using this index.