All regulations
Nonrulemaking
FDA
Open for Comments
FDA-2026-P-3104
Requests that the FDA makes the determination that CABAZITAXEL injection for intravenous use 60 mg/6 mL (10 mg/mL) [NDA 207970] held by Actavis, LLC, an indirect, wholly-owned subsidiary of Teva Pharmaceuticals USA, Inc. was not discontinued for reasons of safety or effectiveness.
Documents
2
Comments
0
Key Dates
Comment Period OpensMar 25, 2026
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
ProPharma
makes the determination that CABAZITAXEL
injection for intravenous use 60 mg 6 mL
10 mg mL
NDA 207970
held by Actavis LLC an indirect
wholly-owned
Data from Regulations.gov