Last Updated: September 28, 2026

Details for New Drug Application (NDA): 211045

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NDA 211045 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Cipla, Jubilant Generics, Ph Health, Puracap Labs Blu, Torrent, and Xiromed, and is included in eight NDAs. It is available from seven suppliers. Additional details are available on the DARIFENACIN HYDROBROMIDE profile page.

The generic ingredient in DARIFENACIN HYDROBROMIDE is darifenacin hydrobromide. There is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

Summary for 211045

Tradename:	DARIFENACIN HYDROBROMIDE
Applicant:	Puracap Labs Blu
Ingredient:	darifenacin hydrobromide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 7.5MG BASE
Approval Date:	Jan 6, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 15MG BASE
Approval Date:	Jan 6, 2020	TE:	AB	RLD:	No

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