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Last Updated: March 26, 2025

Details for New Drug Application (NDA): 203713

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NDA 203713 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, 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, Endo Operations, Esjay Pharma, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Osmotica Pharm Us, 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-five 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-seven suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for 203713

Tradename:	DONEPEZIL HYDROCHLORIDE
Applicant:	Dexcel
Ingredient:	donepezil hydrochloride
Patents:	0

Pharmacology for NDA: 203713

Mechanism of Action	Cholinesterase Inhibitors

Suppliers and Packaging for NDA: 203713

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203713	ANDA	Edenbridge Pharmaceuticals LLC.	42799-954	42799-954-01	30 TABLET, FILM COATED in 1 BOTTLE (42799-954-01)
DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203713	ANDA	Edenbridge Pharmaceuticals LLC.	42799-954	42799-954-02	90 TABLET, FILM COATED in 1 BOTTLE (42799-954-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	23MG
Approval Date:	Feb 19, 2016	TE:	AB	RLD:	No

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