Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021746
Company: WINDTREE THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SURFAXIN LUCINACTANT 8.5ML SUSPENSION;INTRATRACHEAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/06/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021746s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021746Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/03/2013 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/10/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/19/2012 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/06/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021746s000lbl.pdf

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