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Last Updated: February 26, 2021

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Details for New Drug Application (NDA): 077571

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NDA 077571 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Boscogen, Chartwell Rx, Mylan, Paddock Labs Llc, Sun Pharm Inds Inc, and Lupin Ltd, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 077571
Tradename:REPAGLINIDE
Applicant:Sun Pharm Inds Inc
Ingredient:repaglinide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077571
Mechanism of ActionPotassium Channel Antagonists
Suppliers and Packaging for NDA: 077571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
REPAGLINIDE repaglinide TABLET;ORAL 077571 ANDA Sun Pharmaceutical Industries, Inc. 57664-745 57664-745-13 500 TABLET in 1 BOTTLE (57664-745-13)
REPAGLINIDE repaglinide TABLET;ORAL 077571 ANDA Sun Pharmaceutical Industries, Inc. 57664-745 57664-745-18 1000 TABLET in 1 BOTTLE (57664-745-18)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 11, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 11, 2013TE:ABRLD:No

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