Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021844
Company: LEO PHARMA AS
Company: LEO PHARMA AS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DESONATE | DESONIDE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | GEL;TOPICAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/20/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021844lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021844s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021844_desonate_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/14/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/22/2014 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021844s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021844Orig1s008ltr.pdf | |
| 12/29/2009 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021844s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021844s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/22/2014 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021844s008lbl.pdf | |
| 12/29/2009 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021844s002lbl.pdf | |
| 10/20/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021844lbl.pdf |