Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: July 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201634

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NDA 201634 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, Cspc Ouyi, Dexcel Pharma, Dr Reddys, Dr Reddys Labs Ltd, 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 fifty-seven 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. Fifty-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 201634
Tradename:DONEPEZIL HYDROCHLORIDE
Applicant:Indicus Pharma
Ingredient:donepezil hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201634
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 201634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201634 ANDA INDICUS PHARMA LLC 24724-028 24724-028-01 100 TABLET, FILM COATED in 1 BLISTER PACK (24724-028-01)
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201634 ANDA INDICUS PHARMA LLC 24724-028 24724-028-03 30 TABLET, FILM COATED in 1 BOTTLE (24724-028-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 13, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 13, 2012TE:ABRLD:No

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