Details for New Drug Application (NDA): 075795

NDA 075795 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 075795

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

Pharmacology for NDA: 075795

Medical Subject Heading (MeSH) Categories for 075795

Hypoglycemic Agents

Suppliers and Packaging for NDA: 075795

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLIPIZIDE	glipizide	TABLET;ORAL	075795	ANDA	Major Pharmaceuticals	0904-6637	0904-6637-61	100 BLISTER PACK in 1 CARTON (0904-6637-61) / 1 TABLET in 1 BLISTER PACK
GLIPIZIDE	glipizide	TABLET;ORAL	075795	ANDA	QPharma Inc	42708-109	42708-109-30	30 TABLET in 1 BOTTLE (42708-109-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 13, 2001	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 13, 2001	TE:	AB	RLD:	No

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