Dexmethylphenidate Hydrochloride

ANDA 209468, held by Lannett Co Inc. Dexmethylphenidate Hydrochloride.

As of Nov 15, 2026, ANDA 209468 (Dexmethylphenidate Hydrochloride), held by Lannett Co Inc, was first approved by FDA on Sep 25, 2017, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2017
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 25, 2017	Original application	Approved	None posted

Products

3 strengths and forms


Dexmethylphenidate Hydrochloride2.5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride5MG · tablet;oral	Dexmethylphenidate Hydrochloride	Discontinued
Dexmethylphenidate Hydrochloride10MG · tablet;oral	Dexmethylphenidate Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Jul 21, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jun 25, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Sep 25, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 209468
Drugs@FDA: Overview at FDA
Company: Lannett Company

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