Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 213813, held by Granules. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 213813 (Dexmethylphenidate Hydrochloride), held by Granules, was first approved by FDA on Sep 9, 2020, with 4 approved supplements and 0 published complete response letters.

First approved: Sep 9, 2020
Review: Standard
Supplements approved: 4
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). Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Sep 9, 2020	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 5 submissions, including labeling and manufacturing supplements


Oct 30, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Feb 8, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Aug 25, 2023	Supplement 3Labeling · Standard review	Approved	None posted
Aug 25, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Sep 9, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 213813
Drugs@FDA: Overview at FDA
Company: Granules India

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