Treats moderate to severe dementia of the Alzheimer’s type. ANDA 203175, held by Aurobindo Pharma Ltd. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 203175 (Memantine Hydrochloride), held by Aurobindo Pharma Ltd, was first approved by FDA on Oct 13, 2015, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 2015 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;oral | Memantine Hydrochloride | Rx |
| Jun 28, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 13, 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
