Details for New Drug Application (NDA): 212138
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The generic ingredient in EMPAGLIFLOZIN is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
Summary for 212138
Tradename: | EMPAGLIFLOZIN |
Applicant: | Zydus Pharms |
Ingredient: | empagliflozin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 3, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Aug 3, 2022 | TE: | RLD: | No |
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