Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022204
Company: ALLERGAN SALES LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GELNIQUE OXYBUTYNIN CHLORIDE 10% (100MG/PACKET) GEL;TRANSDERMAL Prescription AB 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
01/27/2009 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/2009/022204lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022204s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022204s000_gelnique_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022204s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022204s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022204Orig1s010ltr.pdf
07/10/2015 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022204s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022204Orig1s009ltr.pdf
08/04/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/12/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/10/2012 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022204s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022204Orig1s006ltr.pdf
01/31/2011 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022204s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022204s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022204s010lbl.pdf
07/10/2015 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022204s009lbl.pdf
10/10/2012 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022204s006lbl.pdf
01/31/2011 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022204s004lbl.pdf
01/27/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022204lbl.pdf

GELNIQUE

GEL;TRANSDERMAL; 10% (100MG/PACKET)
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GELNIQUE OXYBUTYNIN CHLORIDE 10% (100MG/PACKET) GEL;TRANSDERMAL Prescription Yes AB 022204 ALLERGAN SALES LLC
OXYBUTYNIN CHLORIDE OXYBUTYNIN CHLORIDE 10% (100MG/PACKET) GEL;TRANSDERMAL Prescription No AB 207329 PAR PHARM INC

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