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Queensland Health
Dow
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QuintilesIMS

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021178

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NDA 021178 describes GLUCOVANCE, which is a drug marketed by Bristol Myers Squibb and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the GLUCOVANCE profile page.

The generic ingredient in GLUCOVANCE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 021178
Tradename:GLUCOVANCE
Applicant:Bristol Myers Squibb
Ingredient:glyburide; metformin hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021178
Suppliers and Packaging for NDA: 021178
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLUCOVANCE glyburide; metformin hydrochloride TABLET;ORAL 021178 NDA Bristol-Myers Squibb Company 0087-6073 N 0087-6073-11
GLUCOVANCE glyburide; metformin hydrochloride TABLET;ORAL 021178 NDA Bristol-Myers Squibb Company 0087-6074 N 0087-6074-11

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 31, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 14, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jul 31, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 14, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Jul 31, 2000TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 14, 2020Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Accenture
Cantor Fitzgerald
Deloitte
Federal Trade Commission
McKinsey
Fish and Richardson
Daiichi Sankyo
Queensland Health

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