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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
Effective Date
August 30, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cisplatin(50 mg in 50 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
0703-5747
Application Number
ANDA074656
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 30, 2022
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 50 mg in 50 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Cisplatin

Product Details

NDC Product Code
0703-5748
Application Number
ANDA074656
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
August 30, 2022
CisplatinActive
Code: Q20Q21Q62JClass: ACTIBQuantity: 100 mg in 100 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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