Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Gland Pharma Limited
Gland Pharma Limited
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
68083-162Application Number
ANDA207323Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
September 26, 2023CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CISPLATIN
Product Details
NDC Product Code
68083-163Application Number
ANDA207323Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUSEffective Date
September 26, 2023HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT