Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 21802, held by Sandoz. Dexmethylphenidate Hydrochloride.
As of Nov 14, 2026, NDA 21802 (Focalin Xr), held by Sandoz, was first approved by FDA on May 26, 2005, with 25 approved supplements and 0 published complete response letters.
Focalin XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Limitations of Use The use of Focalin 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.
| Oct 23, 2009 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2008 | Supplement 12Efficacy (new indication or use) | Approved | |
| Apr 11, 2006 | Supplement 1Efficacy (new indication or use) | Approved | |
| May 26, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Focalin Xr5MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr10MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr20MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr15MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr30MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr40MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr35MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Focalin Xr25MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | RxReference drug |
| Sep 23, 2025 | Supplement 45Labeling · Standard review | Approved | |
| Oct 13, 2023 | Supplement 41Labeling · Standard review | Approved | |
| Oct 13, 2023 | Supplement 38Labeling · Standard review | Approved | |
| Jun 26, 2021 | Supplement 39Labeling | Approved | |
| Nov 19, 2019 | Supplement 36Labeling · Standard review | Approved | |
| Jan 10, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Jan 10, 2019 | Supplement 19Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 33Labeling | Approved | |
| Dec 4, 2015 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jun 12, 2015 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2015 | Supplement 28Labeling | Approved | |
| Dec 12, 2013 | Supplement 26Labeling · Standard review | Approved | |
| Jun 11, 2013 | Supplement 25Labeling · Standard review | Approved | |
| May 2, 2012 | Supplement 24Labeling · Standard review | Approved | |
| Apr 21, 2011 | Supplement 22Manufacturing · Standard review | Approved | |
| Nov 15, 2010 | Supplement 21Labeling · Standard review | Approved | |
| May 4, 2010 | Supplement 17Labeling | Approved | |
| Oct 23, 2009 | Supplement 16Labeling · Standard review | Approved | |
| Oct 23, 2009 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 17, 2008 | Supplement 12Efficacy (new indication or use) | Approved | |
| Apr 25, 2007 | Supplement 9Labeling · Standard review | Approved | |
| Aug 1, 2006 | Supplement 7Manufacturing | Approved | |
| Aug 1, 2006 | Supplement 3Labeling · Standard review | Approved | |
| Apr 11, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Apr 11, 2006 | Supplement 1Efficacy (new indication or use) | Approved | |
| May 26, 2005 | Original applicationNew dosage form · Standard review | Approved |
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
