Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CISplatin
Product Details
NDC Product Code
44567-510Application Number
NDA018057Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 16, 2021Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
CISplatin
Product Details
NDC Product Code
44567-511Application Number
NDA018057Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 16, 2021CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 1 mL
CISplatin
Product Details
NDC Product Code
44567-509Application Number
NDA018057Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
September 16, 2021CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
WaterInactive
Code: 059QF0KO0RClass: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT
natural latex rubberInactive
Code: 2LQ0UUW8INClass: CNTMQuantity: 0 1 in 1 mL