Details for New Drug Application (NDA): 204792

NDA 204792 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 thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.

Summary for 204792

Tradename:	FESOTERODINE FUMARATE
Applicant:	Hetero Labs Ltd V
Ingredient:	fesoterodine fumarate
Patents:	0

Suppliers and Packaging for NDA: 204792

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204792	ANDA	Camber Pharmaceuticals, Inc.	31722-033	31722-033-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-30)
FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204792	ANDA	Camber Pharmaceuticals, Inc.	31722-033	31722-033-90	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (31722-033-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	4MG
Approval Date:	Jan 9, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	8MG
Approval Date:	Jan 9, 2024	TE:	AB	RLD:	No

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