Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202513
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GELNIQUE 3% OXYBUTYNIN 3% GEL, METERED;TRANSDERMAL Discontinued None Yes 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
12/07/2011 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202513s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202513s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513_anturol_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202513Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2015 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202513Orig1s005ltr.pdf
01/09/2013 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202513s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202513Orig1s003ltr_replacement.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/10/2015 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202513s005lbl.pdf
01/09/2013 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202513s003lbl.pdf
12/07/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202513s000lbl.pdf

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