ANDA 79217, held by Hikma. Dronabinol.
As of Nov 13, 2026, ANDA 79217 (Dronabinol), held by Hikma, was first approved by FDA on Jun 20, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2014 | Original application | Approved | None posted |
| Dronabinol2.5MG · capsule;oral | Dronabinol | Discontinued |
| Dronabinol5MG · capsule;oral | Dronabinol | Discontinued |
| Dronabinol10MG · capsule;oral | Dronabinol | Discontinued |
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
