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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 201146

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NDA 201146 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Aiping Pharm Inc, Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sun Pharm Industries, Unichem, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Novitium Pharma, Osmotica Pharm Us, Ph Health, Prinston Inc, Rising, Sciegen Pharms, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Lifesciences, and Zydus Pharms, and is included in forty-seven NDAs. It is available from thirty-three suppliers. Additional details are available on the DONEPEZIL HYDROCHLORIDE profile page.

The generic ingredient in DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for 201146

Tradename:	DONEPEZIL HYDROCHLORIDE
Applicant:	Macleods Pharms Ltd
Ingredient:	donepezil hydrochloride
Patents:	0

Pharmacology for NDA: 201146

Mechanism of Action	Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 201146

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201146	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7951	0615-7951-05	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-05)
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201146	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-7951	0615-7951-39	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7951-39)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 17, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 17, 2012	TE:	AB	RLD:	No

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