Registrants (1)
Bracco Diagnostics Inc
849234661
Manufacturing Establishments (3)
Merck SL
Bracco Diagnostics Inc
Bracco Diagnostics Inc
460082644
E-Z-EM Canada Inc
Bracco Diagnostics Inc
Bracco Diagnostics Inc
204211163
Justesa Imagen, S.A.U
Bracco Diagnostics Inc
Bracco Diagnostics Inc
477020325
Products (1)
Gastrografin
0270-0445
NDA011245
NDA (C73594)
ORAL, RECTAL
April 23, 2018
DiatrizoateActive
Code: V5403H8VG7Class: ACTIBQuantity: 100 mg in 1 mL
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACTQuantity: 3.22 mg in 1 mL
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACTQuantity: 0.403 mg in 1 mL
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACTQuantity: 2.77 mg in 1 mL
Code: 3X9MR4N98UClass: ACTIBQuantity: 660 mg in 1 mL