Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 212631, held by Alkem Labs Ltd. Dexmethylphenidate Hydrochloride.
As of Nov 15, 2026, ANDA 212631 (Dexmethylphenidate Hydrochloride), held by Alkem Labs Ltd, was first approved by FDA on Jul 19, 2019, with 0 approved supplements and 0 published complete response letters.
Dexmethylphenidate hydrochloride is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2019 | Original application | Approved | None posted |
| Dexmethylphenidate Hydrochloride2.5MG · tablet;oral | Dexmethylphenidate Hydrochloride | Rx |
| Dexmethylphenidate Hydrochloride5MG · tablet;oral | Dexmethylphenidate Hydrochloride | Rx |
| Dexmethylphenidate Hydrochloride10MG · tablet;oral | Dexmethylphenidate Hydrochloride | Rx |
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
