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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020471
Company: CHIESI

Products on NDA 020471

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020471

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.

Labels for NDA 020471

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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