Details for New Drug Application (NDA): 216068
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NDA 216068 describes ENZALUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Apotex, Zydus Pharms, and Sandoz, and is included in four NDAs. Additional details are available on the ENZALUTAMIDE profile page.
The generic ingredient in ENZALUTAMIDE is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
The generic ingredient in ENZALUTAMIDE is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
Summary for 216068
| Tradename: | ENZALUTAMIDE |
| Applicant: | Sandoz |
| Ingredient: | enzalutamide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 20, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Apr 20, 2026 | TE: | AB | RLD: | No | ||||
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