Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205525
Company: INSYS DEV CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SYNDROS DRONABINOL 5MG/ML SOLUTION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes
07/01/2016 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Federal Register Notice
Label (PDF)
Letter (PDF)
FR Notice on DEA Scheduling; Date of Approval – March 23, 2017
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note
05/25/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
12/08/2016 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
05/25/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
07/01/2016 ORIG-1 Approval Label (PDF)

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