Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 206931, held by Abhai LLC. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 206931 (Dexmethylphenidate Hydrochloride), held by Abhai LLC, was first approved by FDA on Dec 4, 2015, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 4, 2015
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dexmethylphenidate hydrochloride tablets is 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 3 submissions below

Date	Submission	Status	Documents
Dec 4, 2015	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 3 submissions, including labeling and manufacturing supplements


Sep 10, 2024	Supplement 10Labeling · Standard review	Approved	None posted
May 8, 2023	Supplement 6Labeling · Standard review	Approved	None posted
Dec 4, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 206931
Drugs@FDA: Overview at FDA
Company: ABHAI LLC

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