Treats Attention Deficit Hyperactivity Disorder (ADHD). NDA 217645, held by Tris Pharma Inc. Clonidine Hydrochloride.
As of Nov 13, 2026, NDA 217645 (Onyda Xr), held by Tris Pharma Inc, was first approved by FDA on May 24, 2024, with 2 approved supplements and 0 published complete response letters.
ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 24, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Onyda Xr0.1MG/ML · suspension, extended release;oral | Clonidine Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2025 | Supplement 4Labeling · Standard review | Approved | |
| Dec 6, 2024 | Supplement 1Labeling · Standard review | Approved | |
| May 24, 2024 | 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
