Orange Book product · Generic (ANDA)
CABAZITAXEL
CABAZITAXEL
At a glance
Jun 23, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 23, 2022
4 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CABAZITAXEL
Strength
60MG/1.5ML (40MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 207619
Product number
001
Marketing status
DISCN
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 207693 · ACCORD HLTHCARE
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.
