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Drugs@FDA: FDA-Approved Drugs

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