Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021978
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERDESO DESONIDE 0.05% AEROSOL, FOAM;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
09/19/2006 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/2006/021978lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021978s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021978_verdeso_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021978s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/15/2019 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021978s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021978Orig1s015ltr.pdf
11/09/2016 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/20/2015 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/02/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021978s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021978Orig1s010ltr.pdf
08/22/2011 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021978s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021978s009ltr.pdf
04/22/2010 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021978s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021978s007ltr.pdf
05/01/2007 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/15/2019 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021978s015lbl.pdf
04/02/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021978s010lbl.pdf
08/22/2011 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021978s009lbl.pdf
04/22/2010 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021978s007lbl.pdf
09/19/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021978lbl.pdf

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