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FDA Approval

Cystografin Dilute

CompanyBRACCO DIAGNOSTICS INC (DUNS: 849234661)

Effective Date

October 2, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Diatrizoate meglumine/iodipamide meglumine(180 mg in 1 mL)

Registrants (1)

BRACCO DIAGNOSTICS INC

DUNS Number

849234661

Manufacturing Establishments (2)

PATHEON ITALIA SPA

Labeler

BRACCO DIAGNOSTICS INC

Registrant

BRACCO DIAGNOSTICS INC

DUNS Number

434078638

Justesa Imagen, S.A.U

Labeler

BRACCO DIAGNOSTICS INC

Registrant

BRACCO DIAGNOSTICS INC

DUNS Number

477020325

Products (1)

Cystografin Dilute

NDC Product Code

0270-1410

Application Number

NDA010040

Marketing Category

NDA (C73594)

Route of Administration

INTRAVESICAL

Effective Date

October 2, 2018

Ingredients

edetate disodiumInactive

Code: 7FLD91C86KClass: IACTQuantity: 0.4 mg in 1 mL

Diatrizoate meglumine/iodipamide meglumineActive

Code: 3X9MR4N98UClass: ACTIBQuantity: 180 mg in 1 mL

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