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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217095
Company: TORRENT

Products on ANDA 217095

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217095

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/12/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217095

SORAFENIB TOSYLATE

TABLET;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NEXAVAR	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	Yes	AB	021923	BAYER HLTHCARE
SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	216073	DR REDDYS
SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	207012	MYLAN
SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	209567	TEVA PHARMS USA INC
SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	217095	TORRENT
SORAFENIB TOSYLATE	SORAFENIB TOSYLATE	EQ 200MG BASE	TABLET;ORAL	Prescription	No	AB	209050	YABAO PHARM

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