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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Dronabinol
Trade Name: Marinol
Date Designated: 01/15/1991
Orphan Designation: For the stimulation of appetite and prevention of weight loss in patients with a confirmed diagnosis of AIDS.
Orphan Designation Status: Designated/Approved
Unimed Pharmaceuticals, Inc.
901 Sawyer Rd.
Marietta, Georgia 30062
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Dronabinol
Trade Name: Marinol
Marketing Approval Date: 12/22/1992
Approved Labeled Indication: Treatment of anorexia associated with weight loss in patients with AIDS.
Exclusivity End Date: 12/22/1999 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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