Last Updated: September 28, 2026

Details for New Drug Application (NDA): 202631

✉ Email this page to a colleague

« Back to Dashboard

NDA 202631 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, Macleods Pharms, 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-one suppliers. Additional details are available on the DONEPEZIL HYDROCHLORIDE profile page.

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

Summary for 202631

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

Pharmacology for NDA: 202631

Mechanism of Action	Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 202631

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202631	ANDA	Macleods Pharmaceuticals Limited	33342-061	33342-061-07	30 TABLET, FILM COATED in 1 BOTTLE (33342-061-07)
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202631	ANDA	Macleods Pharmaceuticals Limited	33342-061	33342-061-10	90 TABLET, FILM COATED in 1 BOTTLE (33342-061-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	23MG
Approval Date:	Jan 22, 2014	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.