Details for New Drug Application (NDA): 208237
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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. 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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