Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020744
Company: CHIESI USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUROSURF PORACTANT ALFA 80MG/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
11/18/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20744ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20744_Curosurf.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/01/2016 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/03/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/04/2015 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/15/2014 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/10/2014 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020744s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020744Orig1s028ltr.pdf
02/12/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

04/15/2013 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

04/15/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

09/26/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020744s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020744s019ltr.pdf
12/13/2002 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/17/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/2002 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/05/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/2002 SUPPL-4 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20744s4ltr.pdf
11/21/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/2004 SUPPL-2 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20744scs002ltr.pdf
06/19/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/10/2014 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020744s028lbl.pdf
09/26/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020744s019lbl.pdf
11/18/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20744lbl.pdf

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