Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202129
Company: COVIS
Company: COVIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZETONNA | CICLESONIDE | 0.037MG/INH | AEROSOL, METERED;NASAL | Discontinued | None | Yes | No |
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. |
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 |