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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Dow
US Army
Baxter
Teva
Cantor Fitzgerald
AstraZeneca
QuintilesIMS

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074388

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NDA 074388 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Pharmadax Inc, Teva, Zydus Pharms Usa Inc, Dava Pharms Inc, Hikma, Mylan, Sanofi Aventis Us, and Yaopharma Co Ltd, and is included in twenty-one NDAs. It is available from twenty-six suppliers. Additional details are available on the GLYBURIDE profile page.

The generic ingredient in GLYBURIDE 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 074388
Tradename:GLYBURIDE
Applicant:Teva
Ingredient:glyburide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 074388
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 074388
Suppliers and Packaging for NDA: 074388
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE glyburide TABLET;ORAL 074388 ANDA Teva Pharmaceuticals USA Inc 0093-8342 N 0093-8342-01
GLYBURIDE glyburide TABLET;ORAL 074388 ANDA Teva Pharmaceuticals USA Inc 0093-8343 N 0093-8343-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Aug 29, 1995TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 29, 1995TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 29, 1995TE:AB1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Dow
Harvard Business School
Colorcon
Fish and Richardson
Cipla
Fuji
Daiichi Sankyo
Cerilliant

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