Details for New Drug Application (NDA): 204827

NDA 204827 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 204827

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

Suppliers and Packaging for NDA: 204827

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204827	ANDA	Ascend Laboratories, LLC	67877-064	67877-064-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-30)
FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204827	ANDA	Ascend Laboratories, LLC	67877-064	67877-064-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-064-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	4MG
Approval Date:	Dec 10, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	8MG
Approval Date:	Dec 10, 2015	TE:	AB	RLD:	No

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