Details for New Drug Application (NDA): 208237
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NDA 208237 describes MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Amneal Pharms and Ani Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE profile page.
The generic ingredient in MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
The generic ingredient in MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride; memantine hydrochloride. There are thirty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 208237
| Tradename: | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
| Applicant: | Ani Pharms |
| Ingredient: | donepezil hydrochloride; memantine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;21MG | ||||
| Approval Date: | Dec 15, 2023 | TE: | AB | RLD: | No | ||||
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