ANDA 209754, held by Bionpharma. Dexmethylphenidate Hydrochloride.
As of Nov 15, 2026, ANDA 209754 (Dexmethylphenidate Hydrochloride), held by Bionpharma, was first approved by FDA on Mar 24, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2020 | Original application | Approved | None posted |
| Dexmethylphenidate Hydrochloride5MG · tablet;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride10MG · tablet;oral | Dexmethylphenidate Hydrochloride | Discontinued |
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
