Details for New Drug Application (NDA): 090100
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NDA 090100 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem, Zydus Pharms Usa Inc, Accord Hlthcare, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Endo Operations, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Osmotica Pharm Us, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Lifesciences, and Zydus Pharms, and is included in forty-seven NDAs. It is available from thirty-six 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. Thirty-eight 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
Summary for 090100
| Tradename: | DONEPEZIL HYDROCHLORIDE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | donepezil hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090100
| Mechanism of Action | Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 090100
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090100 | ANDA | Zydus Lifesciences Limited | 65841-749 | 65841-749-01 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-749-01) |
| DONEPEZIL HYDROCHLORIDE | donepezil hydrochloride | TABLET;ORAL | 090100 | ANDA | Zydus Lifesciences Limited | 65841-749 | 65841-749-05 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-749-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Oct 24, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Oct 24, 2012 | TE: | AB | RLD: | No | ||||
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