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Last Updated: August 9, 2020

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Details for New Drug Application (NDA): 090247

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NDA 090247 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 090247
Applicant:Hikma Pharms
Ingredient:donepezil hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 090247
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 090247
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090247 ANDA Hikma Pharmaceuticals USA Inc. 0143-9747 0143-9747-09 90 TABLET, FILM COATED in 1 BOTTLE (0143-9747-09)
DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090247 ANDA Hikma Pharmaceuticals USA Inc. 0143-9747 0143-9747-25 100 TABLET, FILM COATED in 1 BLISTER PACK (0143-9747-25)

Profile for product number 001

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

Profile for product number 002

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

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