Dexmethylphenidate Hydrochloride

Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 209211, held by Cediprof Inc. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 209211 (Dexmethylphenidate Hydrochloride), held by Cediprof Inc, was first approved by FDA on Sep 19, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 19, 2018
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Sep 19, 2018	Original application	Approved	None posted

Products

2 strengths and forms


Dexmethylphenidate Hydrochloride5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Rx
Dexmethylphenidate Hydrochloride10MG · tablet;oral	Dexmethylphenidate Hydrochloride	Rx

All 3 submissions, including labeling and manufacturing supplements


Sep 10, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Jul 20, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Sep 19, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209211
Drugs@FDA: Overview at FDA
Company: Cediprof

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