Memantine Hydrochloride And Donepezil Hydrochloride
ANDA 208328, held by Amneal. Donepezil Hydrochloride; Memantine Hydrochloride.
- First approved: Jan 27, 2017
- Review: Standard
- Supplements approved: 1
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first; all 2 submissions below| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 27, 2017 | Original application | Approved |
Products
4 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Memantine Hydrochloride And Donepezil Hydrochloride10MG;14MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | Rx |
| Memantine Hydrochloride And Donepezil Hydrochloride10MG;28MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | Rx |
| Memantine Hydrochloride And Donepezil Hydrochloride10MG;7MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | Rx |
| Memantine Hydrochloride And Donepezil Hydrochloride10MG;21MG · capsule, extended release;oral | Donepezil Hydrochloride; Memantine Hydrochloride | Rx |
All 2 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2025 | Supplement 1Manufacturing | Approved | None posted |
| Jan 27, 2017 | Original application | Approved |
Identifiers
- Application
- ANDA 208328
- Drugs@FDA
- Overview at FDA
- Company
- Amneal Pharmaceuticals
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters