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Daiichi Sankyo
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US Department of Justice
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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091072

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NDA 091072 describes RIVASTIGMINE TARTRATE, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds Ltd, and Watson Labs, and is included in ten NDAs. It is available from eighteen suppliers. Additional details are available on the RIVASTIGMINE TARTRATE profile page.

The generic ingredient in RIVASTIGMINE TARTRATE is rivastigmine tartrate. There are thirty-two drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 091072
Tradename:RIVASTIGMINE TARTRATE
Applicant:Apotex Inc
Ingredient:rivastigmine tartrate
Patents:0
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091072
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 091072
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091072 ANDA Golden State Medical Supply, Inc. 60429-393 N 60429-393-60
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091072 ANDA Golden State Medical Supply, Inc. 60429-394 N 60429-394-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:May 16, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:May 16, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:May 16, 2013TE:ABRLD:No

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