Orange Book product · Generic (ANDA)
BORTEZOMIB
BORTEZOMIB
At a glance
Jul 26, 2022
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 26, 2022
3 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
BORTEZOMIB
Strength
3.5MG/VIAL
Dosage form
INJECTABLE
Route
INTRAVENOUS, SUBCUTANEOUS
TE code
AP
Application
ANDA 215011
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of BORTEZOMIB
- 2024BORTEZOMIBBrand (NDA)
NDA 212782 · SHILPA
- 2022BORTEZOMIBBrand (NDA)
NDA 215331 · MAIA PHARMS INC
- 2022BORTEZOMIBBrand (NDA)
NDA 215441 · ACCORD HLTHCARE
- 2022BORTEZOMIBBrand (NDA)
NDA 209191 · HOSPIRA
- 2019BORTEZOMIBBrand (NDA)
NDA 206927 · DR REDDYS
- 2017BORTEZOMIBBrand (NDA)
NDA 205004 · FRESENIUS KABI USA
- 2003VELCADEBrand (NDA)
NDA 021602 · TAKEDA PHARMS USA
- 2026BORTEZOMIBGeneric (ANDA)
ANDA 219167 · GLAND
- 2025BORTEZOMIBGeneric (ANDA)
ANDA 216528 · SHUANGCHENG
- 2025BORTEZOMIBGeneric (ANDA)
ANDA 218688 · VILIN BIO MED
- 2024BORTEZOMIBGeneric (ANDA)
ANDA 212204 · HETERO LABS LTD VI
- 2023BORTEZOMIBGeneric (ANDA)
ANDA 216912 · SCINOPHARM TAIWAN
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.
