Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 21284, held by Sandoz. Methylphenidate Hydrochloride.
As of Nov 14, 2026, NDA 21284 (Ritalin La), held by Sandoz, was first approved by FDA on Jun 5, 2002, with 24 approved supplements and 0 published complete response letters.
Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), in pediatric patients 6 to 12 years of age. Limitations of Use The use of methylphenidate hydrochloride extended release capsules 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Ritalin La20MG · capsule, extended release;oral | Methylphenidate Hydrochloride | RxReference drug |
| Ritalin La30MG · capsule, extended release;oral | Methylphenidate Hydrochloride | RxReference drug |
| Ritalin La40MG · capsule, extended release;oral | Methylphenidate Hydrochloride | RxReference drug |
| Ritalin La10MG · capsule, extended release;oral | Methylphenidate Hydrochloride | RxReference drug |
| Ritalin La60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, extended release;oral | Methylphenidate Hydrochloride | DiscontinuedReference drug |
| Sep 23, 2025 | Supplement 50Labeling · Standard review | Approved | |
| Oct 13, 2023 | Supplement 46Labeling · Standard review | Approved | |
| Oct 13, 2023 | Supplement 42Labeling · Standard review | Approved | |
| Jun 26, 2021 | Supplement 43Labeling | Approved | |
| Nov 19, 2019 | Supplement 41Labeling · Standard review | Approved | |
| Jan 10, 2019 | Supplement 29Labeling · Standard review | Approved | |
| Jan 10, 2019 | Supplement 16Labeling · Standard review | Approved | |
| Jan 4, 2017 | Supplement 34Labeling | Approved | |
| Feb 9, 2016 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jun 2, 2015 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2015 | Supplement 27Labeling | Approved | |
| Oct 27, 2014 | Supplement 25Manufacturing · Standard review | Approved | |
| Dec 13, 2013 | Supplement 23Labeling · Standard review | Approved | |
| Oct 25, 2013 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jun 7, 2013 | Supplement 19Labeling · Standard review | Approved | |
| May 6, 2013 | Supplement 20Labeling · Standard review | Approved | |
| Dec 9, 2010 | Supplement 18Labeling · Standard review | Approved | |
| Nov 15, 2010 | Supplement 17Labeling | Approved | |
| Apr 27, 2010 | Supplement 10Labeling · Standard review | Approved | |
| Apr 25, 2007 | Supplement 11Labeling · Standard review | Approved | |
| Aug 8, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Aug 8, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Apr 8, 2004 | Supplement 4Manufacturing · Standard review | Approved | |
| Dec 10, 2002 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2002 | 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
