Quillivant Xr

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 202100, held by Nextwave. Methylphenidate Hydrochloride.

As of Nov 15, 2026, NDA 202100 (Quillivant Xr), held by Nextwave, was first approved by FDA on Sep 27, 2012, with 13 approved supplements and 0 published complete response letters.

First approved: Sep 27, 2012
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

QUILLIVANT XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Limitations of Use The use of QUILLIVANT XR 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 14 submissions below

Date	Submission	Status	Documents
Sep 27, 2012	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Quillivant Xr5MG/ML · for suspension, extended release;oral	Methylphenidate Hydrochloride	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Mar 9, 2026	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 23, 2025	Supplement 24Labeling · Standard review	Approved	Letter Letter Label Medication Guide
Oct 13, 2023	Supplement 23Labeling · Standard review	Approved	Label Letter
Jun 25, 2021	Supplement 18Labeling	Approved	Label Letter
Jan 24, 2017	Supplement 6Labeling · Standard review	Approved	Letter Label
Jan 4, 2017	Supplement 12Labeling	Approved	Letter Label
May 27, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
May 13, 2016	Supplement 7Labeling · Standard review	Approved	Label Letter
Jul 13, 2015	Supplement 5Labeling · Standard review	Approved	Label Letter
Apr 17, 2015	Supplement 4Labeling	Approved	Label Letter
Dec 12, 2013	Supplement 3Labeling · Standard review	Approved	Label Letter
Aug 9, 2013	Supplement 2Labeling · Standard review	Approved	Letter Label
May 15, 2013	Supplement 1Manufacturing · Standard review	Approved	Label
Sep 27, 2012	Original applicationNew dosage form · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 202100
Drugs@FDA: Overview at FDA
Company: NextWave Pharmaceuticals

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