Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125509
Company: ELUSYS THERAPEUTICS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code
ANTHIM OBILTOXAXIMAB 600MG/6ML INJECTABLE;INJECTION Prescription No None  
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes
03/18/2016 ORIG-1 Approval N/A N/A ;
Orphan
Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
 
Supplements
Action Date Submission Submission Classification Letters, Reviews, Labels,
Patient Package Insert
Note
10/20/2016 SUPPL-1 MANUF (CMC)  

Label is not available on this site.

Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note
03/18/2016 ORIG-1 Approval Label (PDF) 

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