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US Department of Justice
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Mallinckrodt
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Generated: February 24, 2018

DrugPatentWatch Database Preview

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, Mylan Pharms Inc, Paddock Llc, Sandoz Inc, Sun Pharm Inds Inc, and Lupin Ltd, and is included in eight NDAs. It is available from twelve suppliers. Additional details are available on the REPAGLINIDE profile page.

The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-eight drug master file entries for this compound. One supplier is listed 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
Therapeutic Class:Blood Glucose Regulators
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 N 57664-745-18
REPAGLINIDE repaglinide TABLET;ORAL 077571 ANDA Sun Pharmaceutical Industries, Inc. 57664-745 N 57664-745-13

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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