Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020521
Company: ONY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INFASURF PRESERVATIVE FREE CALFACTANT 35MG/ML SUSPENSION;INTRATRACHEAL Prescription None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/01/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf
07/01/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf

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