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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 205550

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NDA 205550 describes DARIFENACIN HYDROBROMIDE, which is a drug marketed by Alembic, Aurobindo Pharma, Cipla, Endo Operations, Jubilant Generics, 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 205550

Tradename:	DARIFENACIN HYDROBROMIDE
Applicant:	Jubilant Generics
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:	Oct 12, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 15MG BASE
Approval Date:	Oct 12, 2016	TE:		RLD:	No

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