Details for New Drug Application (NDA): 074686

NDA 074686 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. Twenty suppliers are listed for this compound. Additional details are available on the glyburide profile page.

Summary for 074686

Tradename:	GLYBURIDE (MICRONIZED)
Applicant:	Teva
Ingredient:	glyburide
Patents:	0

Pharmacology for NDA: 074686

Medical Subject Heading (MeSH) Categories for 074686

Hypoglycemic Agents

Suppliers and Packaging for NDA: 074686

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074686	ANDA	Teva Pharmaceuticals USA, Inc.	0093-8034	0093-8034-01	100 TABLET in 1 BOTTLE (0093-8034-01)
GLYBURIDE (MICRONIZED)	glyburide	TABLET;ORAL	074686	ANDA	Teva Pharmaceuticals USA, Inc.	0093-8035	0093-8035-01	100 TABLET in 1 BOTTLE (0093-8035-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.5MG
Approval Date:	Apr 20, 1999	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG
Approval Date:	Apr 20, 1999	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4.5MG
Approval Date:	Apr 20, 1999	TE:		RLD:	No

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