Treats moderate to severe dementia of the Alzheimer's type. ANDA 203293, held by Zydus Pharms. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 203293 (Memantine Hydrochloride), held by Zydus Pharms, was first approved by FDA on Aug 3, 2017, with 1 approved supplement and 0 published complete response letters.
Memantine hydrochloride extended-release capsules are a N-methyl-D-aspartate (NMDA) receptor antagonist indicated for the treatment of moderate to severe dementia of the Alzheimer's type.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2017 | Original application | Approved |
| 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 |
| Mar 15, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 3, 2017 | Original application | Approved |
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
