Orange Book product · Brand (NDA)
BORTEZOMIB
BORTEZOMIB
At a glance
Jul 26, 2022
Approved
Brand (NDA)
Application
Not listed
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
2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215441
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.
- 2024BORTEZOMIBBrand (NDA)
NDA 212782 · SHILPA
- 2022BORTEZOMIBBrand (NDA)
NDA 215331 · MAIA PHARMS INC
- 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
- 2022BORTEZOMIBGeneric (ANDA)
ANDA 205160 · PHARMOBEDIENT
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.
