Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 205489, held by Neos Theraps Inc. Methylphenidate.
As of Nov 15, 2026, NDA 205489 (Cotempla Xr-Odt), held by Neos Theraps Inc, was first approved by FDA on Jun 19, 2017, with 4 approved supplements and 0 published complete response letters.
COTEMPLA XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age. Limitations of Use The use of COTEMPLA XR-ODT 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 19, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Cotempla Xr-Odt8.6MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | RxReference drug |
| Cotempla Xr-Odt17.3MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | RxReference drug |
| Cotempla Xr-Odt25.9MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | RxReference drug |
| Cotempla Xr-Odt34.6MG · tablet, orally disintegrating, extended release;oral | Methylphenidate | DiscontinuedReference drug |
| Sep 23, 2025 | Supplement 21Labeling · Standard review | Approved | |
| Mar 12, 2024 | Supplement 16Manufacturing | Approved | |
| Oct 13, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Jun 25, 2021 | Supplement 7Labeling | Approved | |
| Jun 19, 2017 | 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
