Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
MAIA Pharmaceuticals, Inc.
079211845
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
MAIA Pharmaceuticals, Inc.
MAIA Pharmaceuticals, Inc.
918601238
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
70511-162Application Number
NDA215331Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
August 10, 2022BortezomibActive
Code: 69G8BD63PPClass: ACTIBQuantity: 2.5 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 25 mg in 1 1
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.82 mg in 1 1
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698HClass: IACTQuantity: 22 mg in 1 1
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Bortezomib
Product Details
NDC Product Code
70511-161Application Number
NDA215331Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
August 10, 2022BortezomibActive
Code: 69G8BD63PPClass: ACTIBQuantity: 1 mg in 1 1
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.82 mg in 1 1
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698HClass: IACTQuantity: 20 mg in 1 1
MANNITOLInactive
Code: 3OWL53L36AClass: IACTQuantity: 10 mg in 1 1
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT