Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 204534, held by Novel Labs Inc. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 204534 (Dexmethylphenidate Hydrochloride), held by Novel Labs Inc, was first approved by FDA on Dec 4, 2015, with 3 approved supplements and 0 published complete response letters.

First approved: Dec 4, 2015
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dexmethylphenidate hydrochloride tablet 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 4 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 4 submissions, including labeling and manufacturing supplements


Sep 9, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Sep 9, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Sep 9, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Dec 4, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 204534
Drugs@FDA: Overview at FDA
Company: Novel 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