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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212327
Company: BRISTOL-MYERS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INREBIC FEDRATINIB HYDROCHLORIDE EQ 100MG BASE CAPSULE;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
08/16/2019 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212327Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212327Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/30/2024 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212327s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212327Orig1s006ltr.pdf
05/15/2023 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212327s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212327Orig1s005ltr.pdf
11/23/2021 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212327s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212327Orig1s004ltr.pdf
12/03/2021 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212327s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212327Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/30/2024 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212327s006lbl.pdf
05/15/2023 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212327s005lbl.pdf
12/03/2021 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212327s003lbl.pdf
11/23/2021 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212327s004lbl.pdf
08/16/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf
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