ANDA 206734, held by Sun Pharm Inds Inc. Dexmethylphenidate Hydrochloride.
As of Nov 15, 2026, ANDA 206734 (Dexmethylphenidate Hydrochloride), held by Sun Pharm Inds Inc, was first approved by FDA on Nov 5, 2021, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 5, 2021 | Original application | Approved | None posted |
| Dexmethylphenidate Hydrochloride5MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride10MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride15MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride20MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride25MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride30MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride35MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Dexmethylphenidate Hydrochloride40MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Discontinued |
| Apr 1, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 5, 2021 | Original application | Approved | None posted |
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
