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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
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Generated: June 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202415

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NDA 202415 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Twi Pharms Inc, Sciegen Pharms Inc, 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 Labs, Aurobindo, Allied Pharma Inc, Wockhardt, Jubilant Generics, Sun Pharm Inds, Lupin Ltd, Sun Pharm Inds Ltd, Torrent Pharms, Barr, Sandoz, and Prinston Inc, and is included in forty-four 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 NDA: 202415

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

Pharmacology for NDA: 202415

Mechanism of ActionCholinesterase Inhibitors

Suppliers and Packaging for NDA: 202415

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL 202415 ANDA Actavis Pharma, Inc. 0228-4529 0228-4529-03 30 TABLET, FILM COATED in 1 BOTTLE (0228-4529-03)
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL 202415 ANDA Actavis Pharma, Inc. 0228-4529 0228-4529-09 90 TABLET, FILM COATED in 1 BOTTLE (0228-4529-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength23MG
Approval Date:Dec 17, 2015TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
Queensland Health
Novartis
Boehringer Ingelheim
Colorcon
Cerilliant
Moodys
Argus Health
Daiichi Sankyo
Mallinckrodt

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