Details for New Drug Application (NDA): 206079
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The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 206079
Tradename: | GLYBURIDE |
Applicant: | Impax Labs Inc |
Ingredient: | glyburide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 206079
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.25MG | ||||
Approval Date: | Sep 30, 2015 | TE: | AB2 | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Sep 30, 2015 | TE: | AB2 | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Sep 30, 2015 | TE: | AB2 | RLD: | No |
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