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Generated: October 21, 2018

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Details for New Drug Application (NDA): 208328

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NDA 208328 describes MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Amneal Pharms and is included in one NDA. 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.
Pharmacology for NDA: 208328
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 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 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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG;14MG
Approval Date:Jan 27, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength10MG;28MG
Approval Date:Jan 27, 2017TE:ABRLD:No

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