Amphetamine Sulfate

Sold as Evekeo Odt. Every FDA application for this active ingredient: 1 branded and 18 generic.

As of Nov 15, 2026, FDA lists 19 applications for Amphetamine Sulfate (sold as Evekeo Odt), first approved Jan 30, 2019, with 1 new use approved and 0 published complete response letters.

First approved: Jan 30, 2019
Applications: 19
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $156K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Amphetamine Sulfate	Part D	$121K	-6%	243
Evekeo	Part D	$36K	-51%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

AMPHETAMINE ER 12.5 MG ODT: $15.58 per unitGeneric · new this year
AMPHETAMINE ER 15.7 MG ODT: $15.86 per unitGeneric · new this year
AMPHETAMINE ER 18.8 MG ODT: $15.17 per unitGeneric · new this year
AMPHETAMINE ER 3.1 MG ODT: $16.03 per unitGeneric · new this year
AMPHETAMINE ER 6.3 MG ODT: $15.94 per unitGeneric · new this year
AMPHETAMINE ER 9.4 MG ODT: $16.07 per unitGeneric · new this year
AMPHETAMINE SULFATE 10 MG TAB: $0.452 per unitGeneric · +26% in a year
AMPHETAMINE SULFATE 5 MG TAB: $0.465 per unitGeneric · -20% in a year

FDA Drug Safety Communications

2 communications since 2020 that name this drug; see all communications

FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHDJun 30, 2025
FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditionsMay 11, 2023 · boxed warning

Clinical Trials

23 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Closed-loop tTIS Targeted of the Nac as an Intervention for MUD PatientsAmphetamine Use Disorders · Shanghai Mental Health Center	Not applicable	Not yet recruiting	Sep 3, 2026
Psilocybin Therapy for Methamphetamine Use Disorder and HIVMethamphetamine Use Disorder, Human Immunodeficiency Virus (HIV) · Nicky Mehtani, MD, MPH	Phase 2	Recruiting	Aug 11, 2026
Effects of Stimulant Medications in PTSDAdderall, PTSD · University of Chicago	Phase 1	Not yet recruiting	Jun 24, 2026
EEG Biomarkers for ADHD Stimulant TreatmentADHD · Boston Children's Hospital	Phase 4	Not yet recruiting	Jun 16, 2026
Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite AthletesSafety and Impact of Medically Supervised Performance Enhancing Substance Usage in Healthy Elite Athletes · Enhanced Emirates Limited	Not applicable	Enrolling by invitation	May 6, 2026
Feasibility of Incorporating a Standardized Substance Use Measure With Linked-Brief Intervention Into Routine Psychosocial Care of Adult Childhood Cancer SurvivorsSurvivors of Childhood Cancer, Substance Use · St. Jude Children's Research Hospital	Not applicable	Recruiting	Apr 7, 2026
Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe DepressionAttention-Deficit/Hyperactivity Disorder (ADHD), Depression - Major Depressive Disorder · Prof. Dr. Frank Behrens	Phase 2	Recruiting	May 13, 2025
Effects of Repetitive Transcranial Magnetic Stimulations in Patients With Amphetamine Use DisordersAmphetamine Use Disorders, Amphetamine Use Disorder · TsaoTun Psychiatric Center, Department of Health, Taiwan	Not applicable	Not yet recruiting	May 7, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Feb 26, 1976	BenzedrineANDA 83900	Smith Kline & French	9	Discontinued
Aug 31, 1984	Amphetamine SulfateANDA 83901	Lannett	6	Discontinued
Aug 9, 2012	EvekeoANDA 200166	Azurity	5	Marketed
Sep 26, 2018	Amphetamine SulfateANDA 211139	Amneal Pharms	5	Marketed
Jan 30, 2019	Evekeo OdtNDA 209905 · New dosage form	Azurity	4	Discontinued
Apr 17, 2019	Amphetamine SulfateANDA 211639	Aurolife Pharma LLC	2	Marketed
Aug 5, 2019	Amphetamine SulfateANDA 212619	Granules	4	Marketed
Nov 22, 2019	Amphetamine SulfateANDA 212919	Bionpharma	2	Marketed
Feb 4, 2020	Amphetamine SulfateANDA 212582	Pharmazone	3	Marketed
Mar 11, 2020	Amphetamine SulfateANDA 211861	Prinston	3	Marketed
May 22, 2020	Amphetamine SulfateANDA 212901	Pharmazone	2	Marketed
Jul 14, 2020	Amphetamine SulfateANDA 213898	Dr Reddys Labs SA	3	Discontinued
Aug 24, 2020	Amphetamine SulfateANDA 213763	Ingenus Pharms LLC	3	Discontinued
Oct 27, 2020	Amphetamine SulfateANDA 213720	Alkem Labs Ltd	3	Marketed
Oct 27, 2020	Amphetamine SulfateANDA 213980	Epic Pharma LLC	3	Marketed
Jan 22, 2021	Amphetamine SulfateANDA 213583	Specgx LLC	2	Marketed
Jan 27, 2021	Amphetamine SulfateANDA 212186	Glenmark Pharms Ltd	1	Discontinued
Jan 27, 2021	Amphetamine SulfateANDA 214574	Sun Pharm Inds Inc	3	Discontinued
Sep 7, 2021	Amphetamine SulfateANDA 213852	Rhodes Pharms	2	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA