Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208471
Company: SANOFI-AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code
ADLYXIN LIXISENATIDE 0.15MG/3ML (0.05MG/ML) SOLUTION;SUBCUTANEOUS Prescription Yes None  
ADLYXIN LIXISENATIDE 0.3MG/3ML (0.1MG/ML) SOLUTION;SUBCUTANEOUS Prescription Yes None  
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes
07/27/2016 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
 
Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note
07/27/2016 ORIG-1 Approval Label (PDF) 

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