Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206488
Company: SAREPTA THERAPS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code
EXONDYS 51 ETEPLIRSEN 100MG/2ML (50MG/ML) SOLUTION;IV (INFUSION) Prescription Yes None  
EXONDYS 51 ETEPLIRSEN 500MG/10ML (50MG/ML) SOLUTION;IV (INFUSION) 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
09/19/2016 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
 
Supplements
Action Date Submission Submission Classification Letters, Reviews, Labels,
Patient Package Insert
Note
02/22/2017 SUPPL-3 LABELING  
Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note
09/19/2016 ORIG-1 Approval Label (PDF) 

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