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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 201146


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NDA 201146 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, 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-six 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-eight 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 ActionCholinesterase 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:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 17, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 17, 2012TE:ABRLD:No

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