Bortezomib

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

Company

DUNS: 080548348

Effective Date

July 26, 2022

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

Meitheal Pharmaceuticals Inc.

DUNS Number

529111185

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

NDC Product Code

71288-118

Application Number

ANDA212958

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, SUBCUTANEOUS

Effective Date

July 26, 2022

Ingredients

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

mannitolInactive

Code: 3OWL53L36AClass: IACTQuantity: 35 mg in 1 1