Source facts
FDA issued an approval letter for MARINOL on 2026-03-27. The source metadata identifies NDA 018651 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
MARINOL — FDA Approval Letter (NDA 018651)
Issued to ALKEM LABS LTD. Application is approved as submitted.
Issued
March 27, 2026Application
NDA 505b1 • 018651
Product
MARINOL
Company
ALKEM LABS LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for MARINOL?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 018651.
- 3Submission: supplement.
- 4Sponsor: ALKEM LABS LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MARINOL approval letter
Is MARINOL FDA approved?
This letter documents an FDA approval action: FDA approved NDA 018651 for MARINOL, sponsored by ALKEM LABS LTD, on March 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 018651?
NDA 018651 is the application under which FDA issued this approval letter for MARINOL to ALKEM LABS LTD. The letter is dated March 27, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.