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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
US Department of Justice
Cantor Fitzgerald
Federal Trade Commission
Farmers Insurance
Accenture
Julphar
Boehringer Ingelheim
Teva

Generated: December 12, 2017

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, Sandoz, and Sanofi Aventis Us, and is included in twenty-one NDAs. It is available from thirty-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. Twenty-two suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.

Summary for 074388

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 074388

Ingredient-typeSulfonylurea Compounds

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 0093-8342-01 100 TABLET in 1 BOTTLE (0093-8342-01)
GLYBURIDE glyburide TABLET;ORAL 074388 ANDA Teva Pharmaceuticals USA Inc 0093-8343 0093-8343-10 1000 TABLET in 1 BOTTLE (0093-8343-10)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Healthtrust
Colorcon
Fish and Richardson
Chubb
Fuji
Teva
Covington
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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