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Serving leading biopharmaceutical companies globally:

Cipla
Fish and Richardson
Moodys
Harvard Business School
Merck
Covington
Chubb
QuintilesIMS
McKesson
Colorcon

Generated: November 20, 2017

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 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-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:
1
Applicant:
1
Ingredient:
1
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 0115-1648-01 100 TABLET, FILM COATED in 1 BOTTLE (0115-1648-01)
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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Argus Health
AstraZeneca
Moodys
Federal Trade Commission
Deloitte
Express Scripts
Fuji
Daiichi Sankyo
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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