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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 077130


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NDA 077130 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 077130
Tradename:RIVASTIGMINE TARTRATE
Applicant:Dr Reddys Labs Inc
Ingredient:rivastigmine tartrate
Patents:0
Pharmacology for NDA: 077130
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 077130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077130 ANDA Dr. Reddy's Laboratories Limited 55111-352 55111-352-01 100 CAPSULE in 1 BOTTLE (55111-352-01)
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077130 ANDA Dr. Reddy's Laboratories Limited 55111-352 55111-352-05 500 CAPSULE in 1 BOTTLE (55111-352-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Oct 31, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Oct 31, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Oct 31, 2007TE:ABRLD:No

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