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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 205007


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NDA 205007 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. Twelve suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.
Summary for 205007
Tradename:FESOTERODINE FUMARATE
Applicant:Aurobindo Pharma
Ingredient:fesoterodine fumarate
Patents:0
Suppliers and Packaging for NDA: 205007
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 205007 ANDA Aurobindo Pharma Limited 65862-766 65862-766-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-766-30)
FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 205007 ANDA Aurobindo Pharma Limited 65862-767 65862-767-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-767-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Feb 17, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Feb 17, 2017TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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