Application 207735
- Type
- ANDA
- Sponsor
- BPI LABS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CABAZITAXEL | CABAZITAXEL | UNKNOWN | UNKNOWN | 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 |
|---|---|---|---|---|---|---|
| Jevtana | CABAZITAXEL | Sanofi-Aventis U.S. LLC | de3d9c26-572b-4ea4-9b2d-dd58a2b3e8fa | 2025-10-07 | Boxed warning, Warnings, Adverse reactions | CABAZITAXEL |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 54443 | ORIG | 2018-06-05 |