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Last Updated: December 30, 2025

Details for New Drug Application (NDA): 074387

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NDA 074387 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 074387

Tradename:	GLIPIZIDE
Applicant:	Ani Pharms
Ingredient:	glipizide
Patents:	0

Medical Subject Heading (MeSH) Categories for 074387

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 4, 1996	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 4, 1996	TE:		RLD:	No

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