← FDA DRUG APPROVALS
FDA ANDA · ANDA208328
MEMANTINE AND DONEPEZIL HYDROCHLORIDES EXTENDED-RELEASE
memantine and donepezil
Sponsor: AMNEAL
APPLICATION
ANDA208328
TYPE
ANDA
ORIGINAL APPROVAL
2017-01-27
LATEST ACTION
2025-02-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 21MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 28MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 7MG · CAPSULE, EXTENDED RELEASE · ORAL
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDEPrescription
DONEPEZIL HYDROCHLORIDE 10MG, MEMANTINE HYDROCHLORIDE 14MG · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2025-02-27Manufacturing (CMC) · Supplement 1 · unknownAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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