Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022004
Company: COVIS
Company: COVIS
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 |
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 |