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MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANI PHARMS · Approved 2023-12-15

Drug application

FDA Application #
ANDA208237
Application type
Abbreviated New Drug Application (Generic)
Brand name
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Generic name
MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Active ingredients
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing status
Prescription
Sponsor
ANI PHARMS
Manufacturer
ANI Pharmaceuticals, Inc.
First approval
2023-12-15

Source

Authoritative
Drugs@FDA application overview
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