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 RLD TE Code
ZINBRYTA DACLIZUMAB 150MG/ML INJECTABLE;INJECTION Prescription TBD None  
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes
05/27/2016 ORIG-1 Approval N/A N/A Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
 
Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note
05/27/2016 ORIG-1 Approval Label (PDF) 

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