Dronabinol

As of Nov 13, 2026, ANDA 78292 (Dronabinol), held by Rhodes, was first approved by FDA on Jun 27, 2008, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 27, 2008
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 27, 2008	Original application	Approved	Letter

Products

3 strengths and forms


Dronabinol2.5MG · capsule;oral	Dronabinol	Discontinued
Dronabinol5MG · capsule;oral	Dronabinol	Discontinued
Dronabinol10MG · capsule;oral	Dronabinol	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 31, 2011	Supplement 3Labeling	Approved	None posted
Oct 29, 2010	Supplement 2Labeling	Approved	None posted
Jun 27, 2008	Original application	Approved	Letter

Identifiers

Application: ANDA 78292
Drugs@FDA: Overview at FDA
Company: Rhodes Pharmaceuticals

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