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
0270-0149Application Number
NDA010040Marketing Category
NDA (C73594)Route of Administration
INTRAVENOUSEffective Date
April 15, 2018edetate disodiumInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.4 mg in 1 mL
Code: 3X9MR4N98UClass: ACTIBQuantity: 300 mg in 1 mL