Details for New Drug Application (NDA): 090937

NDA 090937 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, and is included in twenty-three NDAs. It is available from nineteen 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. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for 090937

Tradename:	GLYBURIDE
Applicant:	Heritage
Ingredient:	glyburide
Patents:	0

Pharmacology for NDA: 090937

Medical Subject Heading (MeSH) Categories for 090937

Hypoglycemic Agents

Suppliers and Packaging for NDA: 090937

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLYBURIDE	glyburide	TABLET;ORAL	090937	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-056	23155-056-01	100 TABLET in 1 BOTTLE (23155-056-01)
GLYBURIDE	glyburide	TABLET;ORAL	090937	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-056	23155-056-10	1000 TABLET in 1 BOTTLE (23155-056-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1.25MG
Approval Date:	Feb 28, 2011	TE:	AB1	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Feb 28, 2011	TE:	AB1	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 28, 2011	TE:	AB1	RLD:	No

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