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FDA Approval

Cystografin

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

FDA Approval Summary

Company
BRACCO DIAGNOSTICS INC
DUNS: 849234661
Effective Date
April 15, 2018
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Diatrizoate meglumine/iodipamide meglumine(300 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

BRACCO DIAGNOSTICS INC

849234661

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

PATHEON ITALIA SPA

BRACCO DIAGNOSTICS INC

BRACCO DIAGNOSTICS INC

434078638

Justesa Imagen, S.A.U

BRACCO DIAGNOSTICS INC

BRACCO DIAGNOSTICS INC

477020325

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cystografin

Product Details

NDC Product Code
0270-0149
Application Number
NDA010040
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
April 15, 2018
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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