Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 207901, held by Tris Pharma Inc. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 207901 (Dexmethylphenidate Hydrochloride), held by Tris Pharma Inc, was first approved by FDA on Aug 26, 2016, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2016
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dexmethylphenidate hydrochloride tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 26, 2016	Original application	Approved	None posted

Products

3 strengths and forms


Dexmethylphenidate Hydrochloride2.5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride10MG · tablet;oral	Dexmethylphenidate Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Jun 28, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Jun 28, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Jun 28, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Aug 26, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 207901
Drugs@FDA: Overview at FDA
Company: Tris Pharma

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