Treats Attention Deficit Hyperactivity Disorder (ADHD). ANDA 203614, held by Impax Labs Inc. Dexmethylphenidate Hydrochloride.
As of Nov 15, 2026, ANDA 203614 (Dexmethylphenidate Hydrochloride), held by Impax Labs Inc, was first approved by FDA on Jul 5, 2017, with 5 approved supplements and 0 published complete response letters.
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Limitations of Use The use of dexmethylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2017 | Original application | Approved | None posted |
| Dexmethylphenidate Hydrochloride25MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Rx |
| Dexmethylphenidate Hydrochloride35MG · capsule, extended release;oral | Dexmethylphenidate Hydrochloride | Rx |
| Aug 21, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 21, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 21, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Aug 21, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 29, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 5, 2017 | 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
