Metadate Cd

Treats attention deficit hyperactivity disorder (ADHD). NDA 21259, held by Lannett. Methylphenidate Hydrochloride.

As of Nov 14, 2026, NDA 21259 (Metadate Cd), held by Lannett, was first approved by FDA on Apr 3, 2001, with 24 approved supplements and 0 published complete response letters.

First approved: Apr 3, 2001
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

METADATE CD is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients 6 years of age and older. Limitations of Use The use of METADATE CD 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 25 submissions below

Date	Submission	Status	Documents
Apr 3, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Products

6 strengths and forms


Metadate Cd20MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Metadate Cd30MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Metadate Cd10MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Metadate Cd40MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Metadate Cd50MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Metadate Cd60MG · capsule, extended release;oral	Methylphenidate Hydrochloride	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 36Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 13, 2023	Supplement 34Labeling · Standard review	Approved	Label Letter
Apr 22, 2022	Supplement 25Labeling · Standard review	Approved	Label Letter
Jun 25, 2021	Supplement 32Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 30Labeling	Approved	Letter Label
Jun 15, 2015	Supplement 28Manufacturing · Standard review	Approved	None posted
Apr 17, 2015	Supplement 29Labeling	Approved	Label Letter
Dec 13, 2013	Supplement 27Labeling · Standard review	Approved	Label Letter
Jun 4, 2013	Supplement 26Labeling · Standard review	Approved	Label Letter
May 6, 2013	Supplement 24Labeling · Standard review	Approved	Letter Label
May 6, 2013	Supplement 23Labeling · Standard review	Approved	Letter Label
Oct 18, 2010	Supplement 22Labeling	Approved	Letter Label
Apr 16, 2009	Supplement 21Labeling · Standard review	Approved	Letter Label
Aug 26, 2008	Supplement 19Labeling · Standard review	Approved	Label Letter
May 4, 2007	Supplement 20Labeling · Standard review	Approved	Letter Label
Aug 10, 2006	Supplement 18Labeling · Standard review	Approved	Letter Label
Feb 19, 2006	Supplement 17Manufacturing	Approved	Letter
Sep 22, 2003	Supplement 8Manufacturing · Standard review	Approved	Letter
Jun 19, 2003	Supplement 6Manufacturing · Standard review	Approved	Letter
May 27, 2003	Supplement 5Manufacturing · Standard review	Approved	Letter
Nov 6, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 6, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Sep 18, 2002	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 9, 2002	Supplement 1Labeling · Standard review	Approved	Letter Label
Apr 3, 2001	Original applicationNew dosage form · Standard review	Approved	Letter Review Label

Identifiers

Application: NDA 21259
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