← FDA DRUG APPROVALS

FDA NDA · NDA021303

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE

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

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA021303
TYPE
NDA
ORIGINAL APPROVAL
2001-10-11
LATEST ACTION
2026-04-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ADDERALL XR 10 · ReferencePrescription
AMPHETAMINE ASPARTATE 2.5MG, AMPHETAMINE SULFATE 2.5MG, DEXTROAMPHETAMINE SACCHARATE 2.5MG, DEXTROAMPHETAMINE SULFATE 2.5MG · CAPSULE, EXTENDED RELEASE · ORAL
ADDERALL XR 15 · ReferencePrescription
AMPHETAMINE ASPARTATE 3.75MG, AMPHETAMINE SULFATE 3.75MG, DEXTROAMPHETAMINE SACCHARATE 3.75MG, DEXTROAMPHETAMINE SULFATE 3.75MG · CAPSULE, EXTENDED RELEASE · ORAL
ADDERALL XR 25 · ReferencePrescription
AMPHETAMINE ASPARTATE 6.25MG, AMPHETAMINE SULFATE 6.25MG, DEXTROAMPHETAMINE SACCHARATE 6.25MG, DEXTROAMPHETAMINE SULFATE 6.25MG · CAPSULE, EXTENDED RELEASE · ORAL
ADDERALL XR 20 · ReferencePrescription
AMPHETAMINE ASPARTATE 5MG, AMPHETAMINE SULFATE 5MG, DEXTROAMPHETAMINE SACCHARATE 5MG, DEXTROAMPHETAMINE SULFATE 5MG · CAPSULE, EXTENDED RELEASE · ORAL
ADDERALL XR 5 · ReferencePrescription
AMPHETAMINE ASPARTATE 1.25MG, AMPHETAMINE SULFATE 1.25MG, DEXTROAMPHETAMINE SACCHARATE 1.25MG, DEXTROAMPHETAMINE SULFATE 1.25MG · CAPSULE, EXTENDED RELEASE · ORAL
ADDERALL XR 30 · ReferencePrescription
AMPHETAMINE ASPARTATE 7.5MG, AMPHETAMINE SULFATE 7.5MG, DEXTROAMPHETAMINE SACCHARATE 7.5MG, DEXTROAMPHETAMINE SULFATE 7.5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2026-04-23Labeling · Supplement 40 · standard — Label ↗AP
2025-09-23Labeling · Supplement 42 · standard — Letter ↗AP
2023-10-13Labeling · Supplement 38 · standard — Label ↗AP
2022-02-25Labeling · Supplement 36 · 901 required — Letter ↗AP
2019-07-03Labeling · Supplement 34 · standard — Label ↗AP
2018-07-16Labeling · Supplement 29 · standard — Label ↗AP
2017-01-06Labeling · Supplement 32 · 901 required — Label ↗AP
2015-04-17Labeling · Supplement 31 · standard — Letter ↗AP
2015-03-03Manufacturing (CMC) · Supplement 28 · standardAP
2014-07-24Labeling · Supplement 27 · standard — Letter ↗AP
2013-12-03Labeling · Supplement 26 · standard — Letter ↗AP
2013-06-14Labeling · Supplement 24 · standard — Letter ↗AP
2013-03-08Labeling · Supplement 25 · standard — Letter ↗AP
2012-02-07Labeling · Supplement 23 · unknown — Letter ↗AP
2010-11-12Labeling · Supplement 22 · unknown — Letter ↗AP
2010-11-12Labeling · Supplement 20 · standard — Label ↗AP
2008-11-12Labeling · Supplement 19 · standard — Letter ↗AP
2007-05-22Labeling · Supplement 15 · standard — Letter ↗AP
2006-07-26Labeling · Supplement 13 · standard — Label ↗AP
2006-06-16Labeling · Supplement 10 · standard — Label ↗AP
2005-07-21Efficacy · Supplement 9 · priority — Review ↗AP
2004-08-11Efficacy · Supplement 5 · standard — Review ↗AP
2002-09-13Manufacturing (CMC) · Supplement 3 · standardAP
2002-05-22Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2001-10-11Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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