Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 210365
Company: GW RES LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPIDIOLEX CANNABIDIOL 100MG/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
06/25/2018 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Date of Approval; DEA Scheduling Not Complete
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note
12/12/2018 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note
06/25/2018 ORIG-1 Approval Label (PDF)

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