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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 077870


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NDA 077870 describes GLYBURIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Heritage, Impax Labs Inc, Teva, and Zydus Pharms, and is included in seven NDAs. It is available from eleven suppliers. Additional details are available on the GLYBURIDE AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 077870
Tradename:GLYBURIDE AND METFORMIN HYDROCHLORIDE
Applicant:Aurobindo Pharma
Ingredient:glyburide; metformin hydrochloride
Patents:0
Pharmacology for NDA: 077870
Suppliers and Packaging for NDA: 077870
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 077870 ANDA A-S Medication Solutions 50090-0887 50090-0887-0 60 TABLET, FILM COATED in 1 BOTTLE (50090-0887-0)
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 077870 ANDA A-S Medication Solutions 50090-0887 50090-0887-1 30 TABLET, FILM COATED in 1 BOTTLE (50090-0887-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;250MG
Approval Date:Nov 14, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Nov 14, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Nov 14, 2007TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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