General MedicationsORALStandard
MARINOL
DRONABINOL
Standard Dose
2.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview MARINOL is listed in Drugs@FDA under application 018651 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DRONABINOL Form and strength CAPSULE;ORAL - 2.5MG Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2026-03-25 00:00:00.
Structured Monograph
Clinical summary
Approval overview MARINOL is listed in Drugs@FDA under application 018651 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DRONABINOL Form and strength CAPSULE;ORAL - 2.5MG Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2026-03-25 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.