← FDA DRUG APPROVALS

FDA NDA · NDA022063

MYDAYIS

dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022063
TYPE
NDA
ORIGINAL APPROVAL
2017-06-20
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

MYDAYIS · ReferencePrescription
AMPHETAMINE ASPARTATE 9.375MG, AMPHETAMINE SULFATE 9.375MG, DEXTROAMPHETAMINE SACCHARATE 9.375MG, DEXTROAMPHETAMINE SULFATE 9.375MG · CAPSULE, EXTENDED RELEASE · ORAL
MYDAYIS · ReferencePrescription
AMPHETAMINE ASPARTATE 3.125MG, AMPHETAMINE SULFATE 3.125MG, DEXTROAMPHETAMINE SACCHARATE 3.125MG, DEXTROAMPHETAMINE SULFATE 3.125MG · CAPSULE, EXTENDED RELEASE · ORAL
MYDAYIS · ReferencePrescription
AMPHETAMINE ASPARTATE 12.5MG, AMPHETAMINE SULFATE 12.5MG, DEXTROAMPHETAMINE SACCHARATE 12.5MG, DEXTROAMPHETAMINE SULFATE 12.5MG · CAPSULE, EXTENDED RELEASE · ORAL
MYDAYIS · ReferencePrescription
AMPHETAMINE ASPARTATE 6.25MG, AMPHETAMINE SULFATE 6.25MG, DEXTROAMPHETAMINE SACCHARATE 6.25MG, DEXTROAMPHETAMINE SULFATE 6.25MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-04-23Labeling · Supplement 7 · standard — Label ↗AP
2023-10-13Labeling · Supplement 5 · standard — Label ↗AP
2022-02-25Labeling · Supplement 3 · 901 required — Letter ↗AP
2019-09-13Efficacy · Supplement 1 · priority — Letter ↗AP
2017-06-20Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →