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Details for New Drug Application (NDA): 203419
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NDA 203419 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-one 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-two suppliers are listed for this compound. 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-two suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 203419
| Tradename: | DONEPEZIL HYDROCHLORIDE |
| Applicant: | Indicus Pharma |
| Ingredient: | donepezil hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 23MG | ||||
| Approval Date: | Apr 12, 2016 | TE: | AB | RLD: | No | ||||
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