Active substance
Dronabinol
- US FDA 7
- US price lines 1
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| MARINOL | 2.5MG; 5MG; 10MG | capsule · oral | ALKEM LABS LTD | Prescription | 31 May 1985 |
| DRONABINOL | 2.5MG; 5MG; 10MG | capsule · oral | ASCENT PHARMS INC | Prescription | 7 Feb 2020 |
| DRONABINOL | 2.5MG; 5MG; 10MG | capsule · oral | RHODES | Discontinued | 27 Jun 2008 |
| DRONABINOL | 2.5MG; 5MG; 10MG | capsule · oral | INSYS THERAP | Discontinued | 19 Aug 2011 |
| DRONABINOL | 2.5MG; 5MG; 10MG | capsule · oral | HIKMA PHARMS | Discontinued | 20 Jun 2014 |
| SYNDROS | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | solution · oral | WELLHOUSE PHARMA | Discontinued | 1 Jul 2016 |
| DRONABINOL | 2.5MG; 5MG; 10MG | capsule · oral | LANNETT CO INC | Discontinued | 18 May 2018 |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DRONABINOL 5 MG CAPSULE | $3.3535 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 17 Jan 2023 MARINOL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 21 Sep 2022 SYNDROS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.