Details for New Drug Application (NDA): 208328
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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. Two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride; memantine hydrochloride profile page.
Summary for 208328
Tradename: | MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | donepezil hydrochloride; memantine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208328
Mechanism of Action | Cholinesterase Inhibitors NMDA Receptor Antagonists |
Suppliers and Packaging for NDA: 208328
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 | 208328 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1247 | 69238-1247-3 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-3) |
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride; memantine hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 208328 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1247 | 69238-1247-9 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1247-9) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;14MG | ||||
Approval Date: | Jan 27, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 10MG;28MG | ||||
Approval Date: | Jan 27, 2017 | TE: | RLD: | No |
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