Details for New Drug Application (NDA): 090252
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The generic ingredient in REPAGLINIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 090252
Tradename: | REPAGLINIDE |
Applicant: | Norvium Bioscience |
Ingredient: | repaglinide |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Aug 23, 2013 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jan 22, 2014 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jan 22, 2014 | TE: | RLD: | No |
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