Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 201231, held by Sun Pharm Industries. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 201231 (Dexmethylphenidate Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Sep 24, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 24, 2015
Supplements approved: 5
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 6 submissions below

Date	Submission	Status	Documents
Sep 24, 2015	Original application	Approved	Letter

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 6 submissions, including labeling and manufacturing supplements


Feb 27, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Jul 24, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jul 24, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Sep 24, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 201231
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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