Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202129
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZETONNA CICLESONIDE 0.037MG/INH AEROSOL, METERED;NASAL 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
01/20/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202129s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129_zetonna_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/2014 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf
10/23/2014 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf
10/23/2014 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf
04/22/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/20/2012 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
10/23/2014 SUPPL-6 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf
10/23/2014 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf
10/23/2014 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf
01/20/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf

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