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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 209050


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NDA 209050 describes SORAFENIB TOSYLATE, which is a drug marketed by Dr Reddys, Mylan, Teva Pharms Usa Inc, Torrent, and Yabao Pharm, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the SORAFENIB TOSYLATE profile page.

The generic ingredient in SORAFENIB TOSYLATE is sorafenib tosylate. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.
Summary for 209050
Tradename:SORAFENIB TOSYLATE
Applicant:Yabao Pharm
Ingredient:sorafenib tosylate
Patents:0
Pharmacology for NDA: 209050
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 209050
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209050 ANDA TWi Pharmaceuticals USA, Inc. 24979-715 24979-715-04 60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04)
SORAFENIB TOSYLATE sorafenib tosylate TABLET;ORAL 209050 ANDA TWi Pharmaceuticals USA, Inc. 24979-715 24979-715-44 120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Nov 9, 2022TE:ABRLD:No

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