Adzenys Xr-Odt

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 204326, held by Neos Theraps. Amphetamine.

As of Nov 15, 2026, NDA 204326 (Adzenys Xr-Odt), held by Neos Theraps, was first approved by FDA on Jan 27, 2016, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2016
Review: Standard
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 27, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Pediatric Medical Review

Products

6 strengths and forms


Adzenys Xr-OdtEQ 3.1MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	RxReference drug
Adzenys Xr-OdtEQ 6.3MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	RxReference drug
Adzenys Xr-OdtEQ 9.4MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	RxReference drug
Adzenys Xr-OdtEQ 12.5MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	RxReference drug
Adzenys Xr-OdtEQ 15.7MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	RxReference drug
Adzenys Xr-OdtEQ 18.8MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	RxReference drug

All 9 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 20Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 1, 2025	Supplement 18Labeling · Standard review	Approved	Label Letter
Mar 28, 2025	Supplement 12Manufacturing	Approved	Letter Label
Mar 12, 2024	Supplement 14Manufacturing	Approved	Letter Label
Oct 13, 2023	Supplement 11Labeling · Standard review	Approved	Label Letter
Feb 25, 2022	Supplement 8Labeling	Approved	Label Letter
Jan 4, 2017	Supplement 2Labeling	Approved	Letter Label
Nov 18, 2016	Supplement 1Labeling · Standard review	Approved	Label Letter
Jan 27, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 204326
Drugs@FDA: Overview at FDA
Company: NEOS Therapeutics

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