Last Updated: June 8, 2026

Details for New Drug Application (NDA): 219159

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NDA 219159 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, Graviti Pharms, 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-seven NDAs. It is available from thirty-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 219159

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

Medical Subject Heading (MeSH) Categories for 219159

Hypoglycemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 4, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 4, 2026	TE:	AB	RLD:	No

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