An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022004
Company: COVIS

Products on NDA 022004

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMNARIS	CICLESONIDE	0.05MG/SPRAY	SPRAY, METERED;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/2006	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022004s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022004s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2019	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022004s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022004Orig1s018ltr.pdf
06/12/2013	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
03/17/2016	SUPPL-15	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022004Orig1s015ltr.pdf
03/22/2013	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022004s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022004Orig1s013ltr.pdf
05/07/2010	SUPPL-7	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022004s007ltr.pdf
05/07/2010	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022004s005ltr.pdf
11/21/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022004s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022004s002ltr.pdf

Labels for NDA 022004

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022004s018lbl.pdf
03/22/2013	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022004s013lbl.pdf
05/07/2010	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022004s005lbl.pdf
11/21/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022004s002lbl.pdf
10/20/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022004lbl.pdf

Top