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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202129
Company: COVIS

Summary Review

Products on NDA 202129

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202129

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
02/16/2023	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202129s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202129Orig1s009ltr.pdf
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.

Labels for NDA 202129

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2023	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202129s009lbl.pdf
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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