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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076257

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NDA 076257 describes GLYBURIDE, which is a drug marketed by Aurobindo Pharma, Heritage Pharms Inc, Actavis Elizabeth, Zydus Pharms Usa Inc, Epic Pharma Llc, Impax Labs Inc, Pharmadax Inc, Teva, Sanofi Aventis Us, Sandoz, Hikma, Dava Pharms Inc, and Mylan, 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 076257

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

Pharmacology for NDA: 076257

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 076257

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE
glyburide
TABLET;ORAL 076257 ANDA Major Pharmaceuticals 0904-6137 0904-6137-60 100 TABLET in 1 BOTTLE, PLASTIC (0904-6137-60)
GLYBURIDE
glyburide
TABLET;ORAL 076257 ANDA Major Pharmaceuticals 0904-6138 0904-6138-40 1000 TABLET in 1 BOTTLE, PLASTIC (0904-6138-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Jun 27, 2002TE:AB1RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jun 27, 2002TE:AB1RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 27, 2002TE:AB1RLD:No


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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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