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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208672
Company: MACLEODS PHARMS LTD

Products on ANDA 208672

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208672

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 208672

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL; 10MG;14MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208328	AMNEAL
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208672	MACLEODS PHARMS LTD
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	216901	XIAMEN LP PHARM CO
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;14MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206439	ABBVIE

CAPSULE, EXTENDED RELEASE;ORAL; 10MG;28MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208328	AMNEAL
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	208672	MACLEODS PHARMS LTD
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	No	AB	216901	XIAMEN LP PHARM CO
NAMZARIC	DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206439	ABBVIE

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