Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Curium US LLC
CURIUM US LLC
557570652
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Detectnet
Product Details
NDC Product Code
69945-064Application Number
NDA213227Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 14, 2020Code: N3858377KCClass: ACTIBQuantity: 1.0 mCi in 1 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.05 mL in 1 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACTQuantity: 40 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT