NDA 209905, held by Azurity. Amphetamine Sulfate.
As of Nov 13, 2026, NDA 209905 (Evekeo Odt), held by Azurity, was first approved by FDA on Jan 30, 2019, with 4 approved supplements and 0 published complete response letters.
| Apr 16, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Evekeo Odt5MG · tablet, orally disintegrating;oral | Amphetamine Sulfate | DiscontinuedReference drug |
| Evekeo Odt10MG · tablet, orally disintegrating;oral | Amphetamine Sulfate | DiscontinuedReference drug |
| Evekeo Odt15MG · tablet, orally disintegrating;oral | Amphetamine Sulfate | DiscontinuedReference drug |
| Evekeo Odt20MG · tablet, orally disintegrating;oral | Amphetamine Sulfate | DiscontinuedReference drug |
| Evekeo Odt2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, orally disintegrating;oral | Amphetamine Sulfate | DiscontinuedReference drug |
| Oct 13, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Sep 30, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Feb 25, 2022 | Supplement 2Labeling | Approved | |
| Apr 16, 2021 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2019 | 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
