Orange Book product · Generic (ANDA)
CABAZITAXEL
CABAZITAXEL
At a glance
Oct 26, 2022
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 26, 2022
3 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
CABAZITAXEL
Strength
60MG/1.5ML (40MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 207693
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CABAZITAXEL
- 2024CABAZITAXELBrand (NDA)
NDA 207970 · ACTAVIS
- 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 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.
