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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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US Army
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Cipla
McKesson
Dow
AstraZeneca
Fish and Richardson

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076786

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NDA 076786 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Barr, 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 Pharm Co, 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, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Twi Pharms Inc, Vivimed Global, Wockhardt, and Zhejiang Hisun Pharm, and is included in forty-six NDAs. It is available from fifty suppliers. Additional details are available on the DONEPEZIL HYDROCHLORIDE profile page.

The generic ingredient in DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride. There are thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 076786
Tradename:DONEPEZIL HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:donepezil hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076786
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 076786
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 076786 ANDA Ranbaxy Pharmaceuticals Inc. 63304-128 N 63304-128-10
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 076786 ANDA Ranbaxy Pharmaceuticals Inc. 63304-128 N 63304-128-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Nov 26, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Nov 26, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Queensland Health
Covington
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