Details for New Drug Application (NDA): 208237
NDA 208237 describes MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Amneal, Ani Pharms, Macleods Pharms, and Xiamen Lp Pharm Co, and is included in four NDAs. It is available from five suppliers. 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 is one drug master file entry for this compound. Six 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 is one drug master file entry for this compound. Six 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 |
Pharmacology for NDA: 208237
| Mechanism of Action | Cholinesterase Inhibitors NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 208237
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208237 | ANDA | ANI Pharmaceuticals, Inc. | 62559-207 | 62559-207-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30) |
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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