Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079009

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NDA 079009 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, and is included in seven NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 079009
Pharmacology for NDA: 079009
Suppliers and Packaging for NDA: 079009
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009 ANDA Heritage Pharmaceuticals Inc. 23155-233 23155-233-01 100 TABLET in 1 BOTTLE (23155-233-01)
GLYBURIDE AND METFORMIN HYDROCHLORIDE glyburide; metformin hydrochloride TABLET;ORAL 079009 ANDA Heritage Pharmaceuticals Inc. 23155-233 23155-233-05 500 TABLET in 1 BOTTLE (23155-233-05)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.25MG;250MG
Approval Date:Jun 3, 2009TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jun 3, 2009TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Jun 3, 2009TE:RLD:No

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