Home Applications 207735 Application 207735
Type ANDA
Sponsor BPI LABS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CABAZITAXEL CABAZITAXEL UNKNOWN UNKNOWN No No
Source provenance: Browse the complete Orange Book source catalog .
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.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table 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 Name fallback generic name: CABAZITAXEL
Documents# Document, Submission type, Date table Document Submission type Date 54443 ORIG 2018-06-05