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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022204
Company: ABBVIE

Summary Review

Products on NDA 022204

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GELNIQUE	OXYBUTYNIN CHLORIDE	10% (100MG/PACKET)	GEL;TRANSDERMAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022204

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

Labels for NDA 022204

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

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