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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090425

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NDA 090425 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-six 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-nine suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for 090425

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

Pharmacology for NDA: 090425

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 090425

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090425 ANDA Aidarex Pharmaceuticals LLC 33261-817 33261-817-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-817-30)
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090425 ANDA Aidarex Pharmaceuticals LLC 33261-817 33261-817-90 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-817-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 31, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 31, 2011TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
AstraZeneca
Merck
McKesson
Novartis
Medtronic
Baxter
Colorcon
Chubb

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