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Covington
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Generated: August 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079009

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NDA 079009 describes GLYBURIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Heritage Pharms Inc, Actavis Elizabeth, Teva, Impax Labs Inc, Zydus Pharms Usa Inc, and Aurobindo Pharma, and is included in seven NDAs. It is available from twenty 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. Twenty-one suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for NDA: 079009

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 079009

Suppliers and Packaging for NDA: 079009

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL 079009 ANDA Blenheim Pharmacal, Inc. 10544-579 10544-579-30 30 TABLET in 1 BOTTLE (10544-579-30)
GLYBURIDE AND METFORMIN HYDROCHLORIDE
glyburide; metformin hydrochloride
TABLET;ORAL 079009 ANDA Blenheim Pharmacal, Inc. 10544-579 10544-579-90 90 TABLET in 1 BOTTLE (10544-579-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;250MG
Approval Date:Jun 3, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jun 3, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Jun 3, 2009TE:ABRLD:No


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