Last Updated: August 2, 2026

Details for New Drug Application (NDA): 203034

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NDA 203034 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, 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 are thirty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for 203034

Tradename:	DONEPEZIL HYDROCHLORIDE
Applicant:	Hetero Labs Ltd V
Ingredient:	donepezil hydrochloride
Patents:	0

Pharmacology for NDA: 203034

Mechanism of Action	Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 203034

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203034	ANDA	Camber Pharmaceuticals, Inc.	31722-737	31722-737-01	100 TABLET in 1 BOTTLE (31722-737-01)
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203034	ANDA	Camber Pharmaceuticals, Inc.	31722-737	31722-737-05	500 TABLET in 1 BOTTLE (31722-737-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 30, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 30, 2015	TE:	AB	RLD:	No

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