General MedicationsORALStandard
EPIDIOLEX
CANNABIDIOL
Standard Dose
100MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview EPIDIOLEX is listed in Drugs@FDA under application 210365 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient CANNABIDIOL Form and strength SOLUTION;ORAL - 100MG/ML Sponsor JAZZ PHARMS RES Submission history Latest submission status date: 2025-06-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview EPIDIOLEX is listed in Drugs@FDA under application 210365 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CANNABIDIOL Form and strength SOLUTION;ORAL - 100MG/ML Sponsor JAZZ PHARMS RES Submission history Latest submission status date: 2025-06-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.