Adderall Xr 10, Adderall Xr 20, Adderall Xr 30

NDA 21303, held by Takeda Pharms USA. Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.

As of Nov 13, 2026, NDA 21303 (Adderall Xr 10, Adderall Xr 20, Adderall Xr 30), held by Takeda Pharms USA, was first approved by FDA on Oct 11, 2001, with 24 approved supplements and 0 published complete response letters.

First approved: Oct 11, 2001
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE,

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jul 21, 2005	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Review Label Letter Pediatric Medical Review
Aug 11, 2004	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Oct 11, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

6 strengths and forms

Product	Active ingredient	Marketing
Adderall Xr 102.5MG;2.5MG;2.5MG;2.5MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Adderall Xr 205MG;5MG;5MG;5MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Adderall Xr 307.5MG;7.5MG;7.5MG;7.5MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Adderall Xr 256.25MG;6.25MG;6.25MG;6.25MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Adderall Xr 51.25MG;1.25MG;1.25MG;1.25MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug
Adderall Xr 153.75MG;3.75MG;3.75MG;3.75MG · capsule, extended release;oral	Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate	RxReference drug

All 25 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 23, 2026	Supplement 40Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 23, 2025	Supplement 42Labeling · Standard review	Approved	Letter Label
Oct 13, 2023	Supplement 38Labeling · Standard review	Approved	Label Letter
Feb 25, 2022	Supplement 36Labeling	Approved	Label Letter
Jul 3, 2019	Supplement 34Labeling · Standard review	Approved	Label
Jul 16, 2018	Supplement 29Labeling · Standard review	Approved	Letter Label
Jan 6, 2017	Supplement 32Labeling	Approved	Letter Label
Apr 17, 2015	Supplement 31Labeling · Standard review	Approved	Letter Label
Mar 3, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Jul 24, 2014	Supplement 27Labeling · Standard review	Approved	Label Letter
Dec 3, 2013	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 14, 2013	Supplement 24Labeling · Standard review	Approved	Letter Label
Mar 8, 2013	Supplement 25Labeling · Standard review	Approved	Label Letter
Feb 7, 2012	Supplement 23Labeling	Approved	Letter Label
Nov 12, 2010	Supplement 22Labeling	Approved	Letter Label
Nov 12, 2010	Supplement 20Labeling · Standard review	Approved	Letter Label
Nov 12, 2008	Supplement 19Labeling · Standard review	Approved	Letter
May 22, 2007	Supplement 15Labeling · Standard review	Approved	Letter Label
Jul 26, 2006	Supplement 13Labeling · Standard review	Approved	Label Letter
Jun 16, 2006	Supplement 10Labeling · Standard review	Approved	Label Letter
Jul 21, 2005	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Review Label Letter Pediatric Medical Review
Aug 11, 2004	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Sep 13, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
May 22, 2002	Supplement 1Manufacturing · Standard review	Approved	Review Letter Label
Oct 11, 2001	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21303
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