NDA 204325, held by Neos Theraps Inc. Amphetamine.
As of Nov 15, 2026, NDA 204325 (Adzenys Er), held by Neos Theraps Inc, was first approved by FDA on Sep 15, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adzenys ErEQ 1.25MG BASE/ML · suspension, extended release;oral | Amphetamine | DiscontinuedReference drug |
| Feb 25, 2022 | Supplement 3Labeling | Approved | |
| Sep 15, 2017 | 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
