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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213217
Company: BEIGENE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BRUKINSA ZANUBRUTINIB 80MG 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
11/14/2019 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/213217Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/213217Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2021 SUPPL-5 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213217Orig1s005ltr.pdf
08/31/2021 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213217Orig1s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2021 SUPPL-5 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s005lbl.pdf
08/31/2021 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213217s004lbl.pdf
11/14/2019 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/213217s000lbl.pdf
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