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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 075947

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NDA 075947 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Epic Pharma Llc, Heritage, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Natco Pharma, Sanofi Aventis Us, and Strides Pharma Intl, and is included in twenty-three NDAs. It is available from eighteen suppliers. Additional details are available on the GLYBURIDE profile page.

The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for 075947

Tradename:	GLYBURIDE
Applicant:	Actavis Elizabeth
Ingredient:	glyburide
Patents:	0

Medical Subject Heading (MeSH) Categories for 075947

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Nov 14, 2002	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Nov 14, 2002	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Nov 14, 2002	TE:		RLD:	No

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