Mydayis

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 22063, held by Takeda Pharms USA. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

As of Nov 14, 2026, NDA 22063 (Mydayis), held by Takeda Pharms USA, was first approved by FDA on Jun 20, 2017, with 4 approved supplements and 0 published complete response letters.

First approved: Jun 20, 2017
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MYDAYIS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Sep 13, 2019	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 20, 2017	Original applicationNew dosage form · Standard review	Approved	Pediatric Other Review Letter Label

Products

4 strengths and forms


Mydayis3.125MG;3.125MG;3.125MG;3.125MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Mydayis6.25MG;6.25MG;6.25MG;6.25MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Mydayis9.375MG;9.375MG;9.375MG;9.375MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Mydayis12.5MG;12.5MG;12.5MG;12.5MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Apr 23, 2026	Supplement 7Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 5Labeling · Standard review	Approved	Label Medication Guide Letter
Feb 25, 2022	Supplement 3Labeling	Approved	Label Letter
Sep 13, 2019	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 20, 2017	Original applicationNew dosage form · Standard review	Approved	Pediatric Other Review Letter Label

Identifiers

Application: NDA 22063
Drugs@FDA: Overview at FDA
Company: Takeda Pharmaceuticals USA

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