Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208603
Company: EGALET
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code
ARYMO ER MORPHINE SULFATE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes None  
ARYMO ER MORPHINE SULFATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes None  
ARYMO ER MORPHINE SULFATE 60MG TABLET, EXTENDED RELEASE;ORAL 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
01/09/2017 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
 
Action Date Submission Submission Classification or
Approval
Type
Letters, Reviews, Labels,
Patient Package Insert
Note
01/09/2017 ORIG-1 Approval Label (PDF) 

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