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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076716

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NDA 076716 describes GLYBURIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Heritage Pharms Inc, Impax Labs Inc, Teva, and Zydus Pharms Usa Inc, and is included in seven NDAs. It is available from twenty-one 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-two suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 076716
Tradename:GLYBURIDE AND METFORMIN HYDROCHLORIDE
Applicant:Actavis Elizabeth
Ingredient:glyburide; metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076716
Suppliers and Packaging for NDA: 076716
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076716 ANDA Impax Generics 0115-1648 0115-1648-02 500 TABLET, FILM COATED in 1 BOTTLE (0115-1648-02)
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076716 ANDA Impax Generics 0115-1648 0115-1648-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1648-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;250MG
Approval Date:Jun 28, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jun 28, 2005TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Jun 28, 2005TE:ABRLD:No

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McKesson
Boehringer Ingelheim
Mallinckrodt
Moodys
Queensland Health
Medtronic
Argus Health
McKinsey
Dow

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