Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212904
Company: AVEO PHARMS

Products on NDA 212904

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FOTIVDA	TIVOZANIB HYDROCHLORIDE	EQ 0.89MG BASE	CAPSULE;ORAL	Prescription	None	Yes	No
FOTIVDA	TIVOZANIB HYDROCHLORIDE	EQ 1.34MG BASE	CAPSULE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212904

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/10/2021	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212904s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212904Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/212904Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212904s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212904Orig1s002ltr.pdf

Labels for NDA 212904

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212904s002lbl.pdf
03/10/2021	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212904s000lbl.pdf