Details for New Drug Application (NDA): 217071
NDA 217071 describes ERTUGLIFLOZIN, which is a drug marketed by Aurobindo Pharma Ltd, Hetero Labs Ltd V, and Hikma, and is included in three NDAs. Additional details are available on the ERTUGLIFLOZIN profile page.
The generic ingredient in ERTUGLIFLOZIN is ertugliflozin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ertugliflozin profile page.
The generic ingredient in ERTUGLIFLOZIN is ertugliflozin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ertugliflozin profile page.
Summary for 217071
| Tradename: | ERTUGLIFLOZIN |
| Applicant: | Hetero Labs Ltd V |
| Ingredient: | ertugliflozin |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 17, 2024 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Sep 17, 2024 | TE: | RLD: | No | |||||
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