NDA 22524, held by Aquestive. Ondansetron.
As of Nov 14, 2026, NDA 22524 (Zuplenz), held by Aquestive, was first approved by FDA on Jul 2, 2010, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 2, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Zuplenz4MG · film;oral | Ondansetron | DiscontinuedReference drug |
| Zuplenz8MG · film;oral | Ondansetron | DiscontinuedReference drug |
| Aug 5, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Jun 25, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 18, 2014 | Supplement 3Labeling | Approved | |
| Oct 30, 2013 | Supplement 2Labeling · Standard review | Approved | |
| Jul 2, 2010 | Original applicationNew dosage form · Standard review | Approved |
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
