Last Updated: September 24, 2026

Details for New Drug Application (NDA): 212228

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NDA 212228 describes SORAFENIB TOSYLATE, which is a drug marketed by Apotex, Dr Reddys, Mylan, Teva Pharms Usa Inc, Torrent, and Yabao Pharm, and is included in six 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the sorafenib tosylate profile page.

Summary for 212228

Tradename:	SORAFENIB TOSYLATE
Applicant:	Apotex
Ingredient:	sorafenib tosylate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	Jan 27, 2025	TE:		RLD:	No

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