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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 206483


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NDA 206483 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Epic Pharma Llc, Heritage, Impax Labs Inc, Orient Pharma Co Ltd, Teva, Zydus Pharms, Hikma, Natco Pharma, 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. Twelve suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 206483
Tradename:GLYBURIDE
Applicant:Orient Pharma Co Ltd
Ingredient:glyburide
Patents:0
Medical Subject Heading (MeSH) Categories for 206483

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Feb 22, 2019TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Feb 22, 2019TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 22, 2019TE:AB1RLD:No

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