Details for New Drug Application (NDA): 074305

NDA 074305 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma, Endo Operations, Norvium Bioscience, Unique, Watson Labs, Zydus Pharms, Accord Hlthcare, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Oxford Pharms, Rubicon, Sandoz, Sun Pharm Inds Inc, Watson Labs Teva, Dash Pharms, Epic Pharma Llc, Heritage, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-six NDAs. It is available from forty-one suppliers. Additional details are available on the GLIPIZIDE profile page.

The generic ingredient in GLIPIZIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Summary for 074305

Tradename:	GLIPIZIDE
Applicant:	Sandoz
Ingredient:	glipizide
Patents:	0

Pharmacology for NDA: 074305

Medical Subject Heading (MeSH) Categories for 074305

Hypoglycemic Agents

Suppliers and Packaging for NDA: 074305

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLIPIZIDE	glipizide	TABLET;ORAL	074305	ANDA	Aphena Pharma Solutions - Tennessee, LLC	67544-097	67544-097-53	60 TABLET in 1 BOTTLE, PLASTIC (67544-097-53)
GLIPIZIDE	glipizide	TABLET;ORAL	074305	ANDA	Aphena Pharma Solutions - Tennessee, LLC	67544-097	67544-097-60	90 TABLET in 1 BOTTLE, PLASTIC (67544-097-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 7, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 7, 1995	TE:		RLD:	No

Complete Access Available with Subscription