Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021946
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
XOLEGEL KETOCONAZOLE 2% 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
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
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-Package Insert, Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021946s002lbl.pdf
12/19/2008 SUPPL-2 Labeling-Container/Carton Labels 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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