BELRAPZO

BELRAPZO

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

Company

DUNS: 849818161

Effective Date

January 19, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Bendamustine(100 mg in 1 1)

Products1

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

NDC Product Code

42367-521

Application Number

NDA205580

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

May 9, 2019

Ingredients

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

Code: 981Y8SX18MClass: ACTIBQuantity: 100 mg in 1 1

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

MONOTHIOGLYCEROLInactive

Code: AAO1P0WSXJClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT