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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 205012

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NDA 205012 describes FESOTERODINE FUMARATE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, and Zydus Pharms, and is included in eleven NDAs. It is available from eleven suppliers. Additional details are available on the FESOTERODINE FUMARATE profile page.

The generic ingredient in FESOTERODINE FUMARATE is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.

Summary for 205012

Tradename:	FESOTERODINE FUMARATE
Applicant:	Accord Hlthcare
Ingredient:	fesoterodine fumarate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	4MG
Approval Date:	Jan 4, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	8MG
Approval Date:	Jan 4, 2023	TE:		RLD:	No

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