ANDA 214731, held by Novast Labs Ltd. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 214731 (Memantine Hydrochloride), held by Novast Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2022 | Original application | Tentative approval | None posted |
| Memantine Hydrochloride7MG · capsule, extended release;oral | Memantine Hydrochloride | None (tentative approval) |
| Memantine Hydrochloride14MG · capsule, extended release;oral | Memantine Hydrochloride | None (tentative approval) |
| Memantine Hydrochloride21MG · capsule, extended release;oral | Memantine Hydrochloride | None (tentative approval) |
| Memantine Hydrochloride28MG · capsule, extended release;oral | Memantine Hydrochloride | None (tentative approval) |
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
