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Medicines · US (FDA)

FDA 2022

Proteasome inhibitors

Bortezomib

Approved 2 May 2022Intravenous, SubcutaneousInjectable

The FDA lists this product in 34 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: BORTEZOMIB 3.5MG/VIAL

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

BORTEZOMIB 3.5MG/VIAL · InjectableANDA208460-001 · Prescription
BORTEZOMIB 1MG/VIAL · PowderNDA209191-001 · Prescription
BORTEZOMIB 2.5MG/VIAL · PowderNDA209191-002 · Prescription
BORTEZOMIB 3.5MG/VIAL · InjectableANDA210204-001 · Prescription
BORTEZOMIB 3.5MG/VIAL · InjectableANDA203654-001 · Discontinued
BORTEZOMIB 3.5MG/VIAL · InjectableThis page
BORTEZOMIB 3.5MG/1.4ML · InjectableNDA208645-002 · Tentative approval
BORTEZOMIB 2.5MG/ML · InjectableNDA208645-001 · Tentative approval
BORTEZOMIB 3.5MG/VIAL · InjectableANDA209622-001 · Prescription
BORTEZOMIB 3.5MG/VIAL · InjectableANDA210824-001 · Prescription
BORTEZOMIB 3.5MG/VIAL · InjectableANDA218688-001 · Prescription
BORTEZOMIB 3.5MG/VIAL · Injectable

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA208392-001 · Prescription

BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) · SolutionNDA212782-001 · Prescription

BORTEZOMIB 1MG/VIAL · PowderANDA219167-001 · Prescription

BORTEZOMIB 2.5MG/VIAL · PowderANDA219167-002 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA205857-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · InjectableANDA212825-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA204405-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · PowderNDA206927-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · InjectableANDA212204-001 · Prescription

BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) · SolutionNDA215331-002 · Discontinued

BORTEZOMIB 3.5MG/3.5ML (1MG/ML) · SolutionNDA215331-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · InjectableANDA202963-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA211898-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA215011-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · PowderNDA205004-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · InjectableANDA205160-001 · Discontinued

BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SolutionNDA215441-002 · Discontinued

BORTEZOMIB 2.5MG/ML (2.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SolutionNDA215441-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · InjectableANDA216528-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA216912-001 · Discontinued

BORTEZOMIB 3.5MG/VIAL · InjectableANDA209659-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA212958-001 · Prescription

BORTEZOMIB 3.5MG/VIAL · InjectableANDA213823-001 · Discontinued

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA205533.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Bortezomib
Drug class: Proteasome inhibitors
Route: Intravenous, Subcutaneous
Dosage form: Injectable
Applicant: Apotex
Status: Prescription
FDA approval: 2 May 2022
Application: ANDA205533-001
RxCUI: 358258