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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 077366

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NDA 077366 describes GLIMEPIRIDE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Aurobindo Pharma Ltd, Carlsbad, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Hikma Pharms, Indoco Remedies, Micro Labs, Mylan, Norvium Bioscience, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Teva, 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 077366

Tradename:	GLIMEPIRIDE
Applicant:	Ranbaxy
Ingredient:	glimepiride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Oct 6, 2005	TE:		RLD:	No

Profile for product number 002

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

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