Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021513
Company: ABBVIE

Products on NDA 21513

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ENABLEX	DARIFENACIN HYDROBROMIDE	EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ENABLEX	DARIFENACIN HYDROBROMIDE	EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

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