Treats moderate to severe dementia of the Alzheimer’s type. ANDA 206528, held by Ajanta Pharma Ltd. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 206528 (Memantine Hydrochloride), held by Ajanta Pharma Ltd, was first approved by FDA on Nov 30, 2015, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 2015 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
| Jan 25, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 30, 2015 | 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
