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Generated: May 24, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203907

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NDA 203907 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Barr, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem Labs Ltd, Zydus Pharms Usa Inc, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Cspc Ouyi, Dexcel Pharma, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Pliva Hrvatska Doo, Prinston Inc, Sciegen Pharms Inc, Strides Vivimed, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Twi Pharms, and Wockhardt, and is included in forty-seven NDAs. It is available from fifty-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. Fifty-seven suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 203907
Tradename:DONEPEZIL HYDROCHLORIDE
Applicant:Sciegen Pharms Inc
Ingredient:donepezil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203907
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 203907
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203907 ANDA Camber Pharmaceuticals, Inc. 31722-139 31722-139-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-139-10)
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203907 ANDA Camber Pharmaceuticals, Inc. 31722-140 31722-140-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-140-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 29, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 29, 2014TE:ABRLD:No

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