Application 218731
- Type
- ANDA
- Sponsor
- HIKMA PHARMACEUTICALS USA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENZALUTAMIDE | ENZALUTAMIDE | TABLET | 40MG | No | No |
| 002 | ENZALUTAMIDE | ENZALUTAMIDE | TABLET | 80MG | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Xtandi | ENZALUTAMIDE | Astellas Pharma US, Inc. | b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf | 2026-07-28 | Warnings, Adverse reactions | ENZALUTAMIDE |