Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020471
Company: CHIESI USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYFLO ZILEUTON 300MG TABLET;ORAL Discontinued None No No
ZYFLO ZILEUTON 600MG TABLET;ORAL 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
12/09/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020471Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/08/2012 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020471s017ltr.pdf
08/21/2009 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020471s014,022052s005ltr.pdf
09/28/2005 SUPPL-11 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020471s011ltr.pdf
12/16/2002 SUPPL-9 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20471slr009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020471_s009_Zyflo_Filmtab.pdf
04/23/2001 SUPPL-8 Labeling

Label is not available on this site.

09/04/1998 SUPPL-7 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020471_s007_Zyflo Filmtabs.pdf
09/24/1998 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/08/1997 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1997 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/30/1997 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/21/1997 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
06/08/2012 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020471s017lbl.pdf
08/21/2009 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf
09/28/2005 SUPPL-11 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020471s011lbl.pdf

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