Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 215523, held by Ascent Pharms Inc. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 215523 (Dexmethylphenidate Hydrochloride), held by Ascent Pharms Inc, was first approved by FDA on Dec 8, 2021, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 8, 2021
Review: Standard
Supplements approved: 2
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).

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 8, 2021	Original application	Approved	None posted

Products

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

All 3 submissions, including labeling and manufacturing supplements


Aug 20, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Jan 15, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Dec 8, 2021	Original application	Approved	None posted

Identifiers

Application: ANDA 215523
Drugs@FDA: Overview at FDA
Company: Ascent Pharmaceuticals, Inc.

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