Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 78992, held by Platinum. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 78992 (Dexmethylphenidate Hydrochloride), held by Platinum, was first approved by FDA on Nov 23, 2021, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 23, 2021
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Dexmethylphenidate Hydrochloride Extended-release Capsules 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 6 submissions below


Nov 23, 2021	Original application	Approved	None posted
Nov 18, 2013	Original application	Approved	Letter

Products

6 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 Hydrochloride30MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride20MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride40MG · capsule, extended release;oral	Dexmethylphenidate Hydrochloride	Rx

All 6 submissions, including labeling and manufacturing supplements


Nov 23, 2021	Original application	Approved	None posted
Nov 29, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Aug 22, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Nov 18, 2013	Original application	Approved	Letter

Identifiers

Application: ANDA 78992
Drugs@FDA: Overview at FDA
Company: Platinum

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