Treats moderate to severe dementia of the Alzheimer’s type. ANDA 214651, held by Aurobindo Pharma Ltd. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 214651 (Memantine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Aug 9, 2021, with 0 approved supplements and 0 published complete response letters.
Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 9, 2021 | Original application | Approved | None posted |
| Memantine Hydrochloride7MG · capsule, extended release;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride14MG · capsule, extended release;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride21MG · capsule, extended release;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride28MG · capsule, extended release;oral | Memantine 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
