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Serving hundreds of leading biopharmaceutical companies globally:

US Army
AstraZeneca
Johnson and Johnson
Harvard Business School
Teva
US Department of Justice
Fish and Richardson
Federal Trade Commission
Boehringer Ingelheim

Generated: July 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020357

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NDA 020357 describes GLUCOPHAGE, which is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the GLUCOPHAGE profile page.

The generic ingredient in GLUCOPHAGE is metformin hydrochloride. There are forty-eight drug master file entries for this compound. One hundred and thirteen suppliers are listed for this compound. Additional details are available on the metformin hydrochloride profile page.
Summary for 020357
Tradename:GLUCOPHAGE
Applicant:Bristol Myers Squibb
Ingredient:metformin hydrochloride
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 020357
Ingredient-typeBiguanides
Medical Subject Heading (MeSH) Categories for 020357
Suppliers and Packaging for NDA: 020357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCOPHAGE metformin hydrochloride TABLET;ORAL 020357 NDA Bristol-Myers Squibb Company 0087-6060 N 0087-6060-05
GLUCOPHAGE metformin hydrochloride TABLET;ORAL 020357 NDA Bristol-Myers Squibb Company 0087-6060 N 0087-6060-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength850MG
Approval Date:Mar 3, 1995TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength625MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Nov 5, 1998TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Covington
Chubb
QuintilesIMS
Boehringer Ingelheim
UBS
Merck
Argus Health
McKesson

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