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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021513

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NDA 021513 describes ENABLEX, which is a drug marketed by Abbvie and is included in one NDA. Additional details are available on the ENABLEX profile page.

The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for 021513

Tradename:	ENABLEX
Applicant:	Abbvie
Ingredient:	darifenacin hydrobromide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 7.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 22, 2004	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 22, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021513

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004	5,096,890	⤷ Get Started Free
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004	6,106,864	⤷ Get Started Free
Abbvie	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004	5,096,890	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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