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Serving leading biopharmaceutical companies globally:

Julphar
QuintilesIMS
Chubb
Chinese Patent Office
Fuji
Dow
US Department of Justice
Cipla
Fish and Richardson
McKinsey

Generated: October 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201724

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NDA 201724 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Twi Pharms Inc, Sciegen Pharms Inc, Cadila Pharms Ltd, Zhejiang Hisun Pharm, Dexcel Pharma, Cspc Ouyi Pharm Co, Osmotica Pharm Us, Actavis Elizabeth, Cipla Ltd, Indicus Pharma, Mylan Pharms Inc, Alembic Pharms Ltd, Pliva Hrvatska Doo, Unichem Labs Ltd, Macleods Pharms Ltd, Hetero Labs Ltd V, Accord Hlthcare, Apotex, Par Pharm, Teva, Hikma Pharms, Vivimed Global, Aurobindo, Aci Healthcare Ltd, Wockhardt, Jubilant Generics, Sun Pharm Inds, Lupin Ltd, Sun Pharm Inds Ltd, Torrent Pharms, Barr, Sandoz, and Prinston Inc, and is included in forty-six NDAs. It is available from fifty-five 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-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for NDA: 201724

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201724

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 201724

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL 201724 ANDA Major Pharmaceuticals 0904-6408 0904-6408-61 100 BLISTER PACK in 1 CARTON (0904-6408-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL 201724 ANDA Major Pharmaceuticals 0904-6408 0904-6408-80 1000 TABLET, FILM COATED in 1 BOTTLE (0904-6408-80)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 25, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 25, 2013TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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