Marinol

For Acquired Immune Deficiency Syndrome (AIDS). NDA 18651, held by Alkem Labs Ltd. Dronabinol.

As of Nov 13, 2026, NDA 18651 (Marinol), held by Alkem Labs Ltd, was first approved by FDA on May 31, 1985, with 22 approved supplements and 0 published complete response letters.

First approved: May 31, 1985
Review: Priority
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dronabinol capsules are indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. Dronabinol capsules is a cannabinoid indicated in adults for the treatment of: Anorexia associated with weight loss in patients with AIDS. Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Dec 22, 1992	Supplement 6Efficacy (new indication or use)	Approved	None posted
May 31, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Products

3 strengths and forms


Marinol2.5MG · capsule;oral	Dronabinol	RxReference drug
Marinol5MG · capsule;oral	Dronabinol	RxReference drug
Marinol10MG · capsule;oral	Dronabinol	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Mar 25, 2026	Supplement 36Labeling · Standard review	Approved	Letter Label
Jan 17, 2023	Supplement 33Labeling · Standard review	Approved	Letter Label
Aug 28, 2017	Supplement 29Labeling · Standard review	Approved	Label Letter
Jun 21, 2006	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 21, 2006	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 26, 2005	Supplement 21Labeling · Standard review	Approved	Letter Label
May 21, 2004	Supplement 20Manufacturing · Priority review	Approved	None posted
Apr 28, 2003	Supplement 18Labeling · Standard review	Approved	Letter Label
Sep 6, 2002	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 6, 2002	Supplement 16Manufacturing · Priority review	Approved	None posted
Mar 5, 2002	Supplement 9Manufacturing · Priority review	Approved	None posted
Jan 17, 2002	Supplement 15Manufacturing · Priority review	Approved	None posted
Oct 30, 2001	Supplement 10Manufacturing · Priority review	Approved	None posted
Apr 5, 2001	Supplement 14Manufacturing · Priority review	Approved	None posted
Sep 22, 2000	Supplement 13Labeling · Standard review	Approved	Label
Jun 21, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
Aug 5, 1999	Supplement 11Labeling · Standard review	Approved	Review
Mar 31, 1993	Supplement 4Manufacturing · Priority review	Approved	None posted
Dec 22, 1992	Supplement 6Efficacy (new indication or use)	Approved	None posted
Mar 3, 1992	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 31, 1989	Supplement 3Manufacturing · Priority review	Approved	None posted
Jan 28, 1986	Supplement 1Labeling	Approved	None posted
May 31, 1985	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 18651
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters