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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209606
Company: BRISTOL MYERS SQUIBB

Medication Guide

Products on NDA 209606

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IDHIFA	ENASIDENIB MESYLATE	EQ 50MG BASE	TABLET;ORAL	Prescription	None	Yes	No
IDHIFA	ENASIDENIB MESYLATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209606

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209606Orig1s000.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209606Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209606s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209606Orig1s006ltr.pdf
07/26/2021	SUPPL-5	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209606Orig1s005ltr_.pdf
11/24/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209606Orig1s004ltr.pdf
09/27/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209606s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209606Orig1s002ltr.pdf

Labels for NDA 209606

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209606s006lbl.pdf
11/24/2020	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209606s004lbl.pdf
09/27/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209606s002lbl.pdf
08/01/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209606s000lbl.pdf

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