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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021978
Company: ALMIRALL

Summary Review

Products on NDA 021978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERDESO	DESONIDE	0.05%	AEROSOL, FOAM;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021978

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
03/30/2020	SUPPL-16	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021978Orig1s016ltr.pdf
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.

Labels for NDA 021978

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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