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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 090252

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NDA 090252 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Mylan, Padagis Us, Sun Pharm Inds Inc, and Lupin Ltd, and is included in nine NDAs. It is available from seven 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 090252

Tradename:	REPAGLINIDE
Applicant:	Mylan
Ingredient:	repaglinide
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 23, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Jan 22, 2014	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Jan 22, 2014	TE:		RLD:	No

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