Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 79108, held by Impax Labs Inc. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 79108 (Dexmethylphenidate Hydrochloride), held by Impax Labs Inc, was first approved by FDA on Dec 21, 2015, with 9 approved supplements and 0 published complete response letters.

First approved: Dec 21, 2015
Supplements approved: 9
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 13 submissions below


Dec 21, 2015	Original application	Approved	None posted
Aug 5, 2015	Original application	Approved	None posted
May 19, 2014	Original application	Approved	None posted
Nov 21, 2013	Original application	Approved	Letter

Products

5 strengths and forms


Dexmethylphenidate Hydrochloride5MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride10MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride15MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride20MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride30MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx

All 13 submissions, including labeling and manufacturing supplements


Oct 5, 2026	Supplement 20Labeling · Standard review	Approved	None posted
Dec 17, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Dec 17, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Dec 17, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Dec 17, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Dec 21, 2015	Original application	Approved	None posted
Aug 5, 2015	Original application	Approved	None posted
May 19, 2014	Original application	Approved	None posted
Jan 22, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Nov 21, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 79108
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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