Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hospira, Inc.
141588017
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Hospira, Inc.
Hospira, Inc.
650540227
Products2
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
0409-1703Application Number
NDA209191Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
December 1, 2022BortezomibActive
Code: 69G8BD63PPClass: ACTIBQuantity: 2.5 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 25 mg in 1 1
BORTEZOMIB
Product Details
NDC Product Code
0409-1704Application Number
NDA209191Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
December 1, 2022MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 10 mg in 1 1
BortezomibActive
Code: 69G8BD63PPClass: ACTIBQuantity: 1 mg in 1 1