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 Dilute
Product Details
NDC Product Code
0270-1410Application Number
NDA010040Marketing Category
NDA (C73594)Route of Administration
INTRAVESICALEffective Date
October 2, 2018edetate disodiumInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.4 mg in 1 mL
Code: 3X9MR4N98UClass: ACTIBQuantity: 180 mg in 1 mL