Bortezomib

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

Company

DUNS: 985523874

Effective Date

August 16, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Bortezomib(3.5 mg in 3.5 mL)

Manufacturing Establishments1

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

Labeler

BluePoint Laboratories

DUNS Number

650786952

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

NDC Product Code

68001-541

Application Number

ANDA209622

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

August 16, 2022

Ingredients

MANNITOLInactive

Code: 3OWL53L36AClass: IACTQuantity: 35 mg in 3.5 mL

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