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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091198

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NDA 091198 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Heritage Pharma, 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, Cadila Pharms Ltd, Cipla Ltd, Dexcel Pharma, Dr Reddys, Dr Reddys Labs Ltd, Graviti Pharms, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Pliva Hrvatska Doo, Prinston Inc, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, and Zydus Pharms, and is included in forty-seven NDAs. It is available from forty-three 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. Forty-four suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 091198
Ingredient:donepezil hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 091198
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 091198
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 091198 ANDA Sandoz Inc 0781-5276 0781-5276-64 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5276-64)
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 091198 ANDA Sandoz Inc 0781-5277 0781-5277-64 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0781-5277-64)

Profile for product number 001

Approval Date:May 10, 2011TE:ABRLD:No

Profile for product number 002

Approval Date:May 10, 2011TE:ABRLD:No

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