Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204369
Company: BAYER HEALTHCARE PHARMS

• Summary Review

Products on NDA 204369

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
STIVARGA	REGORAFENIB	40MG	TABLET; ORAL	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204369

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2013	ORIG-1	Approval		PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204369lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204369Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204369Orig1s000SumR.pdf

Labels for NDA 204369

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/25/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204369lbl.pdf

Therapeutic Equivalents for NDA 204369

STIVARGA

There are no Therapeutic Equivalents.