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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021513
Company: ABBVIE

Products on NDA 021513

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENABLEX	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ENABLEX	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021513

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2004	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021513lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021513ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-513_Enablex.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021513s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021513Orig1s017ltr.pdf
01/13/2016	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
12/18/2015	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
09/20/2013	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/09/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/03/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/15/2012	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513Orig1s010ltr.pdf
12/05/2013	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
01/13/2012	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021513s008ltr.pdf
04/18/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021513s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021513s007ltr.pdf
10/19/2010	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021513s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021513s006ltr.pdf
12/12/2008	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s005ltrCorrectedCopy.pdf
04/18/2008	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021513s004ltr.pdf
10/20/2005	SUPPL-2	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021513s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021513s002ltr.pdf

Labels for NDA 021513

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021513s017lbl.pdf
03/15/2012	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s010lbl.pdf
01/13/2012	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021513s008lbl.pdf
04/18/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021513s007lbl.pdf
10/19/2010	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021513s006lbl.pdf
12/12/2008	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s005lbl.pdf
04/18/2008	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021513s004lbl.pdf
10/20/2005	SUPPL-2	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021513s002lbl.pdf
12/22/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021513lbl.pdf

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