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FDA Approval

CISPLATIN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
FOSUN PHARMA USA INC
DUNS: 080920998
Effective Date
August 4, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cisplatin(1 mg in 1 mL)

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
72266-253
Application Number
ANDA207323
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 4, 2023
SODIUM 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
72266-252
Application Number
ANDA207323
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 4, 2023
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 1 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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