Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 78908, held by Teva Pharms USA. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 78908 (Dexmethylphenidate Hydrochloride), held by Teva Pharms USA, was first approved by FDA on May 19, 2014, with 8 approved supplements and 0 published complete response letters.

First approved: May 19, 2014
Supplements approved: 8
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


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

Products

4 strengths and forms


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

All 10 submissions, including labeling and manufacturing supplements


Aug 21, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Aug 21, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Aug 21, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Aug 13, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Aug 13, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 13, 2015	Supplement 7Labeling · Standard review	Approved	None posted
May 19, 2014	Original application	Approved	None posted
Nov 19, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 78908
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