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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 074438

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NDA 074438 describes GLIPIZIDE, which is a drug marketed by Aurobindo Pharma, Ph Health, Pharmobedient, Unique, Watson Labs, Zydus Pharms, Accord Hlthcare, Aiping Pharm Inc, Ani Pharms, Apotex, Aurobindo Pharma Usa, Barr Labs Inc, Chartwell Rx, Oxford Pharms, Rubicon Research, Sun Pharm Inds Inc, Watson Labs Teva, Epic Pharma Llc, Heritage, Novitium Pharma, Teva Pharms, and Zydus Pharms Usa Inc, and is included in twenty-six NDAs. It is available from thirty-five 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 074438

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

Medical Subject Heading (MeSH) Categories for 074438

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 20, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 20, 1995	TE:		RLD:	No

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