Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
BluePoint Laboratories
650540227
Products2
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
68001-609Application Number
ANDA207323Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 18, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
CISPLATIN
Product Details
NDC Product Code
68001-608Application Number
ANDA207323Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
December 18, 2023SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT