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Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

E-Z-EM, INC.

DUNS Number

002041226

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

E-Z-EM Canada Inc

Labeler

E-Z-EM Canada Inc

Registrant

E-Z-EM, INC.

DUNS Number

204211163

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

32909-145

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 7, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 240 mg in 1 mL

ACACIAInactive

Code: 5C5403N26OClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

CARRAGEENAN SODIUMInactive

Code: 7CY8BVL34NClass: IACT

METHYLCELLULOSE (400 MPA.S)Inactive

Code: O0GN6F9B2YClass: IACT

DIMETHICONE 350Inactive

Code: 2Y53S6ATLUClass: IACT

DIMETHICONE 1000Inactive

Code: MCU2324216Class: IACT

POTASSIUM CHLORIDEInactive

Code: 660YQ98I10Class: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4Class: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

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Product Details

NDC Product Code

32909-146

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 7, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 240 mg in 1 mL

ACACIAInactive

Code: 5C5403N26OClass: IACT

ANHYDROUS CITRIC ACIDInactive

Code: XF417D3PSLClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SORBITOLInactive

Code: 506T60A25RClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

CARRAGEENAN SODIUMInactive

Code: 7CY8BVL34NClass: IACT

DIMETHICONE 350Inactive

Code: 2Y53S6ATLUClass: IACT

DIMETHICONE 1000Inactive

Code: MCU2324216Class: IACT

METHYLCELLULOSE (400 MPA.S)Inactive

Code: O0GN6F9B2YClass: IACT

POTASSIUM CHLORIDEInactive

Code: 660YQ98I10Class: IACT

POTASSIUM SORBATEInactive

Code: 1VPU26JZZ4Class: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TYClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EUClass: IACT

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

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FDA Approval Summary

Registrants1

Manufacturing Establishments1

Products2

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Product Details

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Product Details