MedPath
FDA Approval

Varibar Pudding

March 1, 2023

HUMAN PRESCRIPTION DRUG LABEL

Barium sulfate(400 mg in 1 mL)

Registrants (1)

E-Z-EM, INC.

002041226

Manufacturing Establishments (1)

E-Z-EM Canada Inc

E-Z-EM Canada Inc

E-Z-EM, INC.

204211163

Products (1)

Varibar Pudding

32909-125

NDA208844

NDA (C73594)

ORAL

October 15, 2018

Code: 25BB7EKE2EClass: ACTIBQuantity: 400 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLUClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311Class: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJClass: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2DClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
XYLITOLInactive
Code: VCQ006KQ1EClass: IACT
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