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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 203581


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NDA 203581 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Epic Pharma Llc, Heritage Pharms, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Mylan, Sanofi Aventis Us, and Strides Pharma, and is included in twenty-three NDAs. It is available from nineteen 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. Ten suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 203581
Tradename:GLYBURIDE
Applicant:Chartwell Rx
Ingredient:glyburide
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203581

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1.25MG
Approval Date:Apr 14, 2016TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Apr 14, 2016TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Apr 14, 2016TE:RLD:No

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