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Serving leading biopharmaceutical companies globally:

Express Scripts
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Julphar
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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076345

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NDA 076345 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 076345

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

Pharmacology for NDA: 076345

Suppliers and Packaging for NDA: 076345

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345 ANDA Rebel Distributors Corp 21695-568 21695-568-30 30 TABLET, FILM COATED in 1 BOTTLE (21695-568-30)
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 076345 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-897 35356-897-90 90 TABLET, FILM COATED in 1 BOTTLE (35356-897-90)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;250MG
Approval Date:Feb 18, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Feb 18, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Feb 18, 2004TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
Fish and Richardson
Cerilliant
Argus Health
Chinese Patent Office
Citi
Colorcon
US Army
Medtronic

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