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Last Updated: April 2, 2025

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, Chartwell Rx, Kenton, Macleods Pharms Ltd, Norvium Bioscience, Padagis Us, Sun Pharm Inds Inc, and Lupin Ltd, and is included in nine NDAs. It is available from five 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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jul 11, 2013	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jul 11, 2013	TE:	AB	RLD:	No

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