ANDA 208756, held by Rhodes Pharms. Dexmethylphenidate Hydrochloride.
As of Nov 15, 2026, ANDA 208756 (Dexmethylphenidate Hydrochloride), held by Rhodes Pharms, was first approved by FDA on Nov 20, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2017 | Original application | Approved | None posted |
| Dexmethylphenidate Hydrochloride2.5MG · tablet;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| 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
