← FDA DRUG APPROVALS

FDA NDA · NDA018651

DRONABINOL

Sponsor: ALKEM LABS LTD

APPLICATION
NDA018651
TYPE
NDA
ORIGINAL APPROVAL
1985-05-31
LATEST ACTION
2026-03-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

MARINOL · ReferencePrescription
DRONABINOL 10MG · CAPSULE · ORAL
MARINOL · ReferencePrescription
DRONABINOL 2.5MG · CAPSULE · ORAL
MARINOL · ReferencePrescription
DRONABINOL 5MG · CAPSULE · ORAL

Approval history

2026-03-25Labeling · Supplement 36 · standard — Letter ↗AP
2023-01-17Labeling · Supplement 33 · standard — Letter ↗AP
2017-08-28Labeling · Supplement 29 · standard — Label ↗AP
2006-06-21Labeling · Supplement 26 · standard — Label ↗AP
2006-06-21Labeling · Supplement 25 · standard — Letter ↗AP
2005-04-26Labeling · Supplement 21 · standard — Letter ↗AP
2004-05-21Manufacturing (CMC) · Supplement 20 · priorityAP
2003-04-28Labeling · Supplement 18 · standard — Letter ↗AP
2002-09-06Manufacturing (CMC) · Supplement 17 · priorityAP
2002-09-06Manufacturing (CMC) · Supplement 16 · priorityAP
2002-03-05Manufacturing (CMC) · Supplement 9 · priorityAP
2002-01-17Manufacturing (CMC) · Supplement 15 · priorityAP
2001-10-30Manufacturing (CMC) · Supplement 10 · priorityAP
2001-04-05Manufacturing (CMC) · Supplement 14 · priorityAP
2000-09-22Labeling · Supplement 13 · standard — Label ↗AP
2000-06-21Manufacturing (CMC) · Supplement 12 · priorityAP
1999-08-05Labeling · Supplement 11 · standard — Review ↗AP
1993-03-31Manufacturing (CMC) · Supplement 4 · priorityAP
1992-12-22Efficacy · Supplement 6AP
1992-03-03Manufacturing (CMC) · Supplement 5 · priorityAP
1989-03-31Manufacturing (CMC) · Supplement 3 · priorityAP
1986-01-28Labeling · Supplement 1AP
1985-05-31Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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