Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 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 Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/01/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20521lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20521ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20521_Infasurf.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/11/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

10/18/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

12/23/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/01/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020521s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020521s024ltr.pdf
12/10/2009 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

09/13/2002 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/2002 SUPPL-8 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20521scm008ltr.pdf
04/18/2002 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2002 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/2000 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/14/1999 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/17/1999 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
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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