Amphetamine

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 209253, held by Actavis Labs Fl Inc. Amphetamine.

As of Nov 14, 2026, ANDA 209253 (Amphetamine), held by Actavis Labs Fl Inc, was first approved by FDA on Jun 22, 2023, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 22, 2023
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amphetamine extended-release orally disintegrating tablets are a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Limitations of Use The use of amphetamine extended-release orally disintegrating tablets are not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 22, 2023	Original application	Approved	Letter

Products

6 strengths and forms


AmphetamineEQ 3.1MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	Rx
AmphetamineEQ 6.3MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	Rx
AmphetamineEQ 9.4MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	Rx
AmphetamineEQ 12.5MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	Rx
AmphetamineEQ 15.7MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	Rx
AmphetamineEQ 18.8MG BASE · tablet, orally disintegrating, extended release;oral	Amphetamine	Rx

All 4 submissions, including labeling and manufacturing supplements


Oct 19, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Aug 8, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Aug 8, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jun 22, 2023	Original application	Approved	Letter

Identifiers

Application: ANDA 209253
Drugs@FDA: Overview at FDA
Company: Actavis Laboratories FL

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