Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 202731, held by Teva Pharms USA. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 202731 (Dexmethylphenidate Hydrochloride), held by Teva Pharms USA, was first approved by FDA on Jul 5, 2017, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 5, 2017
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is 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 10 submissions below


Jul 5, 2017	Original application	Approved	None posted
May 19, 2014	Original application	Approved	None posted
Nov 19, 2013	Original application	Approved	Letter Letter

Products

5 strengths and forms


Dexmethylphenidate Hydrochloride25MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride40MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride30MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride35MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride30MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx

All 10 submissions, including labeling and manufacturing supplements


Aug 21, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Aug 21, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Aug 21, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Jul 5, 2017	Original application	Approved	None posted
Aug 13, 2015	Supplement 4Labeling · Standard review	Approved	None posted
May 19, 2014	Original application	Approved	None posted
Jan 28, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Nov 19, 2013	Original application	Approved	Letter Letter

Identifiers

Application: ANDA 202731
Drugs@FDA: Overview at FDA
Company: Teva 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