.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091198

« Back to Dashboard
NDA 091198 describes DONEPEZIL HYDROCHLORIDE, which is a drug marketed by Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Twi Pharms Inc, Sciegen Pharms Inc, Dexcel Pharma, Cspc Ouyi Pharm Co, Osmotica Pharm Us, Actavis Elizabeth, Cipla Ltd, Indicus Pharma, Mylan Pharms Inc, Alembic Pharms Ltd, Pliva Hrvatska Doo, Unichem Labs Ltd, Macleods Pharms Ltd, Hetero Labs Ltd V, Accord Hlthcare, Apotex, Par Pharm, Teva, Hikma Pharms, Vivimed Labs, Aurobindo, Roxane, Wockhardt, Jubilant Generics, Sun Pharm Inds, Lupin Ltd, Sun Pharm Inds Ltd, Torrent Pharms, Barr, Sandoz, and Prinston Inc, and is included in forty-three NDAs. It is available from fifty-four suppliers. Additional details are available on the DONEPEZIL HYDROCHLORIDE profile page.

The generic ingredient in DONEPEZIL HYDROCHLORIDE is donepezil hydrochloride. There are thirty drug master file entries for this compound. Fifty-six suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for NDA: 091198

Tradename:
DONEPEZIL HYDROCHLORIDE
Applicant:
Sandoz
Ingredient:
donepezil hydrochloride
Patents:0
Therapeutic Class:Antidementia Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:May 10, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:May 10, 2011TE:ABRLD:No


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc