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FDA Approval

Cystografin

CompanyBRACCO DIAGNOSTICS INC (DUNS: 849234661)

Effective Date

April 15, 2018

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Diatrizoate meglumine/iodipamide meglumine(300 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

NDC Product Code

0270-0149

Application Number

NDA010040

Marketing Category

NDA (C73594)

Route of Administration

INTRAVENOUS

Effective Date

April 15, 2018

Ingredients

edetate disodiumInactive

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

Diatrizoate meglumine/iodipamide meglumineActive

Code: 3X9MR4N98UClass: ACTIBQuantity: 300 mg in 1 mL

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