For Acquired Immune Deficiency Syndrome (AIDS). ANDA 207421, held by Ascent Pharms Inc. Dronabinol.
As of Nov 13, 2026, ANDA 207421 (Dronabinol), held by Ascent Pharms Inc, was first approved by FDA on Feb 7, 2020, with 1 approved supplement and 0 published complete response letters.
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 are 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 7, 2020 | Original application | Approved | None posted |
| Dronabinol2.5MG · capsule;oral | Dronabinol | Rx |
| Dronabinol5MG · capsule;oral | Dronabinol | Rx |
| Dronabinol10MG · capsule;oral | Dronabinol | Rx |
| Dec 14, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 7, 2020 | Original application | Approved | None posted |
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
