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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206079

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NDA 206079 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 thirty-four 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. Twenty-two suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 206079
Applicant:Impax Labs Inc
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Pharmacology for NDA: 206079
Ingredient-typeSulfonylurea Compounds
Medical Subject Heading (MeSH) Categories for 206079
Suppliers and Packaging for NDA: 206079
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE glyburide TABLET;ORAL 206079 ANDA CorePharma, LLC 64720-290 N 64720-290-10
GLYBURIDE glyburide TABLET;ORAL 206079 ANDA CorePharma, LLC 64720-290 N 64720-290-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Sep 30, 2015TE:AB2RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Sep 30, 2015TE:AB2RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 30, 2015TE:AB2RLD:No

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