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FDA Approval

Bortezomib

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

FDA Approval Summary

Company
Hospira, Inc.
DUNS: 141588017
Effective Date
July 25, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Bortezomib(3.5 mg in 1 1)

Products1

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

Bortezomib

Product Details

NDC Product Code
0409-1700
Application Number
ANDA208460
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
July 25, 2022
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 35 mg in 1 1
Code: 69G8BD63PPClass: ACTIBQuantity: 3.5 mg in 1 1
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