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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078555

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NDA 078555 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Padagis Us, Quagen, 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 078555

Tradename:	REPAGLINIDE
Applicant:	Chartwell Rx
Ingredient:	repaglinide
Patents:	0

Pharmacology for NDA: 078555

Mechanism of Action	Potassium Channel Antagonists

Suppliers and Packaging for NDA: 078555

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
REPAGLINIDE	repaglinide	TABLET;ORAL	078555	ANDA	Chartwell RX, LLC	62135-946	62135-946-90	90 TABLET in 1 BOTTLE (62135-946-90)
REPAGLINIDE	repaglinide	TABLET;ORAL	078555	ANDA	Chartwell RX, LLC	62135-947	62135-947-90	90 TABLET in 1 BOTTLE (62135-947-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Nov 22, 2013	TE:	AB	RLD:	No

Profile for product number 002

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

Profile for product number 003

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

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