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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 077295

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NDA 077295 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Anda Repository, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Micro Labs, Mylan, Prinston Inc, Quagen, Ranbaxy, Ranbaxy Labs Ltd, Regcon Holdings, and Watson Labs, and is included in seventeen NDAs. It is available from thirty-one suppliers. Additional details are available on the GLIMEPIRIDE profile page.

The generic ingredient in GLIMEPIRIDE is glimepiride. There are sixteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the glimepiride profile page.

Summary for 077295

Tradename:	GLIMEPIRIDE
Applicant:	Chartwell Molecular
Ingredient:	glimepiride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Oct 6, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Oct 6, 2005	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Oct 6, 2005	TE:	AB	RLD:	No

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