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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021946
Company: ALMIRALL

Products on NDA 021946

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XOLEGEL	KETOCONAZOLE	2%	GEL;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021946

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021946lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021946s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021946s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021946s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021946Orig1s007ltr.pdf
02/27/2013	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/10/2012	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021946s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021946s005ltr.pdf
12/06/2010	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021946s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021946s004ltr.pdf
12/30/2009	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021946s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021946s003ltr.pdf
12/19/2008	SUPPL-2	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf

Labels for NDA 021946

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/26/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021946s007lbl.pdf
05/10/2012	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021946s005lbl.pdf
12/06/2010	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021946s004lbl.pdf
12/30/2009	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021946s003lbl.pdf
12/19/2008	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf
12/19/2008	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf
07/28/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021946lbl.pdf

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