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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211192
Company: SERVIER

Medication Guide

Products on NDA 211192

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TIBSOVO	IVOSIDENIB	250MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211192

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211192Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211192Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-11	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211192Orig1s011ltr.pdf
05/25/2022	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211192Orig1s009ltr.pdf
08/25/2021	SUPPL-8	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211192_s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211192Orig1s008ltr.pdf
03/18/2021	SUPPL-7	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211192Orig1s007ltr.pdf
03/17/2020	SUPPL-2	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211192Orig1s002ltr.pdf
05/02/2019	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211192s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211192Orig1s001ltr.pdf

Labels for NDA 211192

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2023	SUPPL-11	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211192s011lbl.pdf
05/25/2022	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211192s009lbl.pdf
08/25/2021	SUPPL-8	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211192_s008lbl.pdf
05/02/2019	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211192s001lbl.pdf
07/20/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211192s000lbl.pdf

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