Concerta

Treats attention deficit hyperactivity disorder (ADHD). NDA 21121, held by Janssen Pharms. Methylphenidate Hydrochloride.

As of Nov 13, 2026, NDA 21121 (Concerta), held by Janssen Pharms, was first approved by FDA on Aug 1, 2000, with 30 approved supplements and 0 published complete response letters.

First approved: Aug 1, 2000
Review: Standard
Supplements approved: 30
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

CONCERTA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 65 years old. Limitations of Use The use of CONCERTA 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 31 submissions below

Date	Submission	Status	Documents
Nov 4, 2009	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 27, 2008	Supplement 17Efficacy (new indication or use)	Approved	Review Letter Label
Oct 21, 2004	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Written Request
Aug 1, 2000	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Products

4 strengths and forms

Product	Active ingredient	Marketing
Concerta18MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Concerta36MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Concerta54MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug
Concerta27MG · tablet, extended release;oral	Methylphenidate Hydrochloride	RxReference drug

All 31 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 10, 2026	Supplement 54Labeling · Standard review	Approved	Label Letter
Feb 2, 2026	Supplement 45Labeling · Standard review	Approved	Label Medication Guide
Feb 2, 2026	Supplement 40Labeling · Standard review	Approved	Label
Feb 2, 2026	Supplement 34Labeling · Standard review	Approved	Label
Sep 23, 2025	Supplement 53Labeling · Standard review	Approved	Letter Label
Oct 13, 2023	Supplement 49Labeling · Standard review	Approved	Label Letter
Jun 25, 2021	Supplement 44Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 38Labeling	Approved	Letter Label
Nov 30, 2016	Supplement 37Manufacturing · Standard review	Approved	Review
Apr 17, 2015	Supplement 35Labeling · Standard review	Approved	Label Letter
Aug 11, 2014	Supplement 33Manufacturing · Standard review	Approved	None posted
Dec 12, 2013	Supplement 32Labeling · Standard review	Approved	Label Letter
Jul 30, 2013	Supplement 30Manufacturing · Standard review	Approved	None posted
Jun 12, 2013	Supplement 31Labeling · Standard review	Approved	Label Letter
May 3, 2013	Supplement 29Labeling · Standard review	Approved	Label Letter
Nov 23, 2010	Supplement 27Labeling	Approved	Label Letter
Nov 23, 2010	Supplement 26Labeling	Approved	Label Letter
Nov 4, 2009	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 14, 2009	Supplement 20Manufacturing	Approved	None posted
Jun 27, 2008	Supplement 17Efficacy (new indication or use)	Approved	Review Letter Label
Jun 27, 2008	Supplement 15Labeling · Standard review	Approved	Letter Label
May 3, 2007	Supplement 14Labeling · Standard review	Approved	Letter Label
Sep 7, 2006	Supplement 12Labeling · Standard review	Approved	Letter Label
Sep 7, 2006	Supplement 9Labeling · Standard review	Approved	Letter Label
Oct 21, 2004	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric Medical Review Pediatric Written Request
Dec 18, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 1, 2002	Supplement 4Manufacturing · Standard review	Approved	Review Letter
Mar 4, 2002	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 26, 2001	Supplement 2Labeling · Standard review	Approved	None posted
Dec 8, 2000	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 1, 2000	Original applicationNew dosage form · Standard review	Approved	Letter Label Review

Identifiers

Application: NDA 21121
Drugs@FDA: Overview at FDA
Company: Janssen Pharmaceuticals, Inc.

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