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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077131


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NDA 077131 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 077131
Tradename:RIVASTIGMINE TARTRATE
Applicant:Sun Pharm
Ingredient:rivastigmine tartrate
Patents:0
Pharmacology for NDA: 077131
Mechanism of ActionCholinesterase Inhibitors
Suppliers and Packaging for NDA: 077131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131 ANDA Sun Pharmaceutical Industries, Inc. 62756-145 62756-145-13 500 CAPSULE in 1 BOTTLE (62756-145-13)
RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131 ANDA Sun Pharmaceutical Industries, Inc. 62756-145 62756-145-61 100 BLISTER PACK in 1 BOX, UNIT-DOSE (62756-145-61) / 1 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1.5MG BASE
Approval Date:Oct 22, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 3MG BASE
Approval Date:Oct 22, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4.5MG BASE
Approval Date:Oct 22, 2007TE:ABRLD:No

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