Registrants (1)
BRACCO DIAGNOSTICS INC
849234661
Manufacturing Establishments (1)
E-Z-EM Canada Inc
E-Z-EM Canada Inc
BRACCO DIAGNOSTICS INC
204211163
Products (2)
E-Z-Paque
32909-186
NDA208143
NDA (C73594)
ORAL
October 15, 2020
Barium sulfateActive
Code: 25BB7EKE2EClass: ACTIBQuantity: 0.6 g in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLUClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
E-Z-Paque
32909-187
NDA208143
NDA (C73594)
ORAL
October 15, 2020
Barium sulfateActive
Code: 25BB7EKE2EClass: ACTIBQuantity: 0.6 g in 1 mL
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311Class: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLUClass: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT