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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 209571

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NDA 209571 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Cipla, Jubilant Generics, Ph Health, Polygen Pharms, Torrent, and Xiromed, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DARIFENACIN HYDROBROMIDE profile page.

The generic ingredient in DARIFENACIN HYDROBROMIDE 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 209571

Tradename:	DARIFENACIN HYDROBROMIDE
Applicant:	Xiromed
Ingredient:	darifenacin hydrobromide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 15MG BASE
Approval Date:	Oct 22, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Oct 22, 2019	TE:		RLD:	No

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