Details for New Drug Application (NDA): 214874

NDA 214874 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 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 214874

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

Pharmacology for NDA: 214874

Medical Subject Heading (MeSH) Categories for 214874

Hypoglycemic Agents

Suppliers and Packaging for NDA: 214874

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLIPIZIDE	glipizide	TABLET;ORAL	214874	ANDA	TruPharma LLC	52817-385	52817-385-10	100 TABLET in 1 BOTTLE (52817-385-10)
GLIPIZIDE	glipizide	TABLET;ORAL	214874	ANDA	TruPharma LLC	52817-385	52817-385-50	500 TABLET in 1 BOTTLE (52817-385-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 3, 2023	TE:		RLD:	No
Regulatory Exclusivity Expiration:	Apr 15, 2024
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 3, 2023	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 3, 2023	TE:	AB	RLD:	No

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