Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021844
Company: LEO PHARMA AS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESONATE DESONIDE 0.05% GEL;TOPICAL 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 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

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