Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Astellas Pharma US, Inc.
605764828
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Seagen Inc.
SEAGEN INC.
Astellas Pharma US, Inc.
028484371
BSP Pharmaceuticals S.p.A (BSP)
SEAGEN INC.
Astellas Pharma US, Inc.
857007830
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PADCEV EJFV
Product Details
NDC Product Code
51144-020Application Number
BLA761137Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
May 31, 2022POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.4 mg in 2 mL
Enfortumab vedotinActive
Code: DLE8519RWMClass: ACTIBQuantity: 20 mg in 2 mL
HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 2.8 mg in 2 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 4.62 mg in 2 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 110 mg in 2 mL
PADCEV EJFV
Product Details
NDC Product Code
51144-030Application Number
BLA761137Marketing Category
BLA (C73585)Route of Administration
INTRAVENOUSEffective Date
May 31, 2022HISTIDINEInactive
Code: 4QD397987EClass: IACTQuantity: 4.2 mg in 3 mL
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Code: X573657P6PClass: IACTQuantity: 6.93 mg in 3 mL
POLYSORBATE 20Inactive
Code: 7T1F30V5YHClass: IACTQuantity: 0.6 mg in 3 mL
Enfortumab vedotinActive
Code: DLE8519RWMClass: ACTIBQuantity: 30 mg in 3 mL
TREHALOSE DIHYDRATEInactive
Code: 7YIN7J07X4Class: IACTQuantity: 165 mg in 3 mL