Focalin

Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 21278, held by Sandoz. Dexmethylphenidate Hydrochloride.

As of Nov 14, 2026, NDA 21278 (Focalin), held by Sandoz, was first approved by FDA on Nov 13, 2001, with 20 approved supplements and 0 published complete response letters.

First approved: Nov 13, 2001
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Focalin is 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 21 submissions below

Date	Submission	Status	Documents
Nov 13, 2001	Original applicationNew dosage form · Standard review	Approved	Label Review Letter

Products

3 strengths and forms


Focalin2.5MG · tablet;oral	Dexmethylphenidate Hydrochloride	RxReference drug
Focalin5MG · tablet;oral	Dexmethylphenidate Hydrochloride	RxReference drug
Focalin10MG · tablet;oral	Dexmethylphenidate Hydrochloride	RxReference drug

All 21 submissions, including labeling and manufacturing supplements


Oct 13, 2023	Supplement 31Labeling · Standard review	Approved	Label Medication Guide Letter
Oct 13, 2023	Supplement 28Labeling · Standard review	Approved	Label Letter
Jun 26, 2021	Supplement 29Labeling	Approved	Letter Label
Nov 19, 2019	Supplement 26Labeling · Standard review	Approved	Label Letter
Jan 10, 2019	Supplement 19Labeling · Standard review	Approved	Letter Label
Jan 10, 2019	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 4, 2017	Supplement 23Labeling	Approved	Letter Label
May 13, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 4, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Apr 17, 2015	Supplement 18Labeling	Approved	Label Letter
Dec 12, 2013	Supplement 17Labeling · Standard review	Approved	Label Letter
Jun 11, 2013	Supplement 16Labeling · Standard review	Approved	Label Letter
May 2, 2012	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 9, 2010	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 15, 2010	Supplement 12Labeling · Standard review	Approved	Letter Label
Apr 25, 2007	Supplement 8Labeling · Standard review	Approved	Letter Label
Mar 8, 2007	Supplement 7Labeling · Standard review	Approved	Letter Label
Aug 24, 2006	Supplement 5Labeling · Standard review	Approved	Letter Label
Aug 24, 2006	Supplement 4Labeling · Standard review	Approved	Letter Label
Jan 3, 2002	Supplement 1Labeling · Standard review	Approved	None posted
Nov 13, 2001	Original applicationNew dosage form · Standard review	Approved	Label Review Letter

Identifiers

Application: NDA 21278
Drugs@FDA: Overview at FDA
Company: Sandoz

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