Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 022004
Company: COVIS PHARMA BV
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMNARIS CICLESONIDE 0.05MG/INH SPRAY, 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
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
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English