Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020922
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLAGE MEQUINOL; TRETINOIN 2%;0.01% SOLUTION;TOPICAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/10/1999 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20922ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-922_Solage.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/30/2009 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020922s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020922s006ltr.pdf
04/25/2007 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020922s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020922s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/30/2009 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020922s006lbl.pdf
04/25/2007 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020922s003lbl.pdf
12/10/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20922lbl.pdf

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