Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 211230
Company: JAZZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SUNOSI SOLRIAMFETOL 75MG TABLET;ORAL Prescription None Yes No
SUNOSI SOLRIAMFETOL 150MG TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes
03/20/2019 ORIG-2 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Date of Approval; DEA Scheduling Not Complete
03/20/2019 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Date of Approval; DEA Scheduling Not Complete
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
03/20/2019 ORIG-2 Approval Label (PDF)
03/20/2019 ORIG-1 Approval Label (PDF)

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