BORTEZOMIB

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 968961354

Effective Date

July 29, 2023

Labeling Type

Human Prescription Drug Label

Active Ingredients

Bortezomib(3.5 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Eugia US LLC

DUNS Number

872201704

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

55150-337

Application Number

ANDA212825

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 29, 2023

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACT

Code: 69G8BD63PPClass: ACTIBQuantity: 3.5 mg in 1 1