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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 203114

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NDA 203114 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 Inc, 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-four 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-six suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for 203114

Tradename:	DONEPEZIL HYDROCHLORIDE
Applicant:	Osmotica Pharm Us
Ingredient:	donepezil hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	23MG
Approval Date:	Jan 26, 2016	TE:		RLD:	No

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