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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 020055

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NDA 020055 describes GLYBURIDE (MICRONIZED), which is a drug marketed by Chartwell Rx, Hikma, Natco Pharma, Sanofi Aventis Us, Strides Pharma, and Teva, and is included in six NDAs. It is available from one supplier. Additional details are available on the GLYBURIDE (MICRONIZED) profile page.

The generic ingredient in GLYBURIDE (MICRONIZED) is glyburide. There are twenty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the glyburide profile page.

Summary for 020055

Tradename:	GLYBURIDE (MICRONIZED)
Applicant:	Sanofi Aventis Us
Ingredient:	glyburide
Patents:	0

Medical Subject Heading (MeSH) Categories for 020055

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Apr 17, 1992	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Apr 17, 1992	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Mar 8, 2000	TE:		RLD:	No

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