Orange Book product · Brand (NDA)
CABAZITAXEL
CABAZITAXEL
At a glance
Mar 14, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 14, 2024
2 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
CABAZITAXEL
Strength
60MG/6ML (10MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 207970
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2021CABAZITAXELBrand (NDA)
NDA 207949 · ACCORD HLTHCARE
- 2010JEVTANA KITBrand (NDA)
NDA 201023 · SANOFI AVENTIS US
- 2023CABAZITAXELGeneric (ANDA)
ANDA 207381 · MYLAN LABS LTD
- 2023CABAZITAXELGeneric (ANDA)
ANDA 207736 · APOTEX
- 2023CABAZITAXELGeneric (ANDA)
ANDA 207718 · DR REDDYS
- 2022CABAZITAXELGeneric (ANDA)
ANDA 207693 · ACCORD HLTHCARE
- 2022CABAZITAXELGeneric (ANDA)
ANDA 207619 · BRECKENRIDGE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
