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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 204973


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NDA 204973 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 204973
Tradename:FESOTERODINE FUMARATE
Applicant:Alembic
Ingredient:fesoterodine fumarate
Patents:0
Suppliers and Packaging for NDA: 204973
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204973 ANDA Alembic Pharmaceuticals Limited 46708-175 46708-175-10 100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-175-10)
FESOTERODINE FUMARATE fesoterodine fumarate TABLET, EXTENDED RELEASE;ORAL 204973 ANDA Alembic Pharmaceuticals Limited 46708-175 46708-175-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-175-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Jan 4, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8MG
Approval Date:Jan 4, 2023TE:ABRLD:No

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