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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091689


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NDA 091689 describes RIVASTIGMINE TARTRATE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in ten NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for 091689
Tradename:RIVASTIGMINE TARTRATE
Applicant:Alembic Pharms Ltd
Ingredient:rivastigmine tartrate
Patents:0
Pharmacology for NDA: 091689
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 091689
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689 ANDA Alembic Pharmaceuticals Limited 46708-063 46708-063-10 100 BLISTER PACK in 1 BOX, UNIT-DOSE (46708-063-10) / 10 CAPSULE in 1 BLISTER PACK (46708-063-11)
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689 ANDA Alembic Pharmaceuticals Limited 46708-063 46708-063-30 30 CAPSULE in 1 BOTTLE (46708-063-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Jun 12, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Jun 12, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Jun 12, 2012TE:ABRLD:No

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