ANDA 210587, held by Puracap Labs Blu. Memantine Hydrochloride.
As of Nov 15, 2026, ANDA 210587 (Memantine Hydrochloride), held by Puracap Labs Blu, was first approved by FDA on Dec 11, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2020 | Original application | Approved | None posted |
| Memantine Hydrochloride5MG · tablet;oral | Memantine Hydrochloride | Rx |
| Memantine Hydrochloride10MG · tablet;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
