Treats attention-deficit/hyperactivity disorder (ADHD). NDA 220320, held by Map77. Atomoxetine Hydrochloride.
As of Nov 13, 2026, NDA 220320 (Atoncy), held by Map77, was first approved by FDA on Mar 20, 2026, with 0 approved supplements and 0 published complete response letters.
Atomoxetine oral solution is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients 6 years of age and older. Atomoxetine oral solution is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. Atomoxetine oral solution is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2026 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| AtoncyEQ 4MG BASE/ML · solution;oral | Atomoxetine Hydrochloride | RxReference drug |
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
