Last Updated: November 13, 2026

Details for New Drug Application (NDA): 091190

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NDA 091190 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Alicora, Aurobindo Pharma, Cipla, Jubilant Generics, Ph Health, 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 091190

Tradename:	DARIFENACIN HYDROBROMIDE
Applicant:	Ph Health
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
Approval Date:	Mar 13, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 15MG BASE
Approval Date:	Mar 13, 2015	TE:		RLD:	No

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