Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207012
Company: MYLAN

Products on ANDA 207012

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 207012

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207012Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/05/2024	SUPPL-3	Labeling, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207012

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