Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022052
Company: CHIESI USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZYFLO CR ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
05/30/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022052s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022052_zyflo_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2014 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/30/2011 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022052s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022052s009ltr.pdf
09/04/2009 SUPPL-5 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022052s009lbl.pdf
09/04/2009 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020471s014,022052s005lbl.pdf
05/30/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022052lbl.pdf

ZYFLO CR

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ZILEUTON ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204929 RISING PHARMS INC
ZYFLO CR ZILEUTON 600MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 022052 CHIESI USA INC

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