Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761029
Company: BIOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZINBRYTA DACLIZUMAB 150MG/ML INJECTABLE;INJECTION Prescription None TBD No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/27/2016 ORIG-1 Approval N/A N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761029Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/761029Orig1s000SumR.pdf
Supplements
Action Date Submission Submission Classification Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/26/2017 SUPPL-1 Efficacy-Manufacturing Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761029Orig1s001ltr.pdf
Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/26/2017 SUPPL-1 Efficacy-Manufacturing Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761029s001lbl.pdf
05/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761029s000lbl.pdf

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