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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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Covington
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Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206748

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NDA 206748 describes GLYBURIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Heritage Pharms Inc, Impax Labs Inc, Teva, and Zydus Pharms Usa Inc, and is included in seven NDAs. It is available from twenty-one suppliers. Additional details are available on the GLYBURIDE AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in GLYBURIDE AND METFORMIN HYDROCHLORIDE 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 206748
Tradename:GLYBURIDE AND METFORMIN HYDROCHLORIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:glyburide; metformin hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206748
Suppliers and Packaging for NDA: 206748
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 206748 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-469 N 55700-469-30
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 206748 ANDA Lake Erie Medical DBA Quality Care Products LLC 55700-469 N 55700-469-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG;250MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Feb 29, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Feb 29, 2016TE:ABRLD:No

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Cerilliant
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