Readi-Cat 2

Registrants (1)

BRACCO DIAGNOSTICS INC

DUNS Number

849234661

Manufacturing Establishments (1)

E-Z-EM Canada Inc

Labeler

E-Z-EM Canada Inc

Registrant

BRACCO DIAGNOSTICS INC

DUNS Number

204211163

Products (10)

Readi-Cat 2 Mochaccino Smoothie

NDC Product Code

32909-777

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

Readi-Cat 2 Creamy Vanilla Smoothie

NDC Product Code

32909-756

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

Readi-Cat 2 Banana Smoothie

NDC Product Code

32909-742

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

Readi-Cat 2 Creamy Vanilla Smoothie

NDC Product Code

32909-746

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

Readi-Cat 2 Mochaccino Smoothie

NDC Product Code

32909-747

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

Readi-Cat 2 Berry Smoothie

NDC Product Code

32909-711

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

Readi-Cat 2 Banana Smoothie

NDC Product Code

32909-722

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

NDC Product Code

32909-744

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

Readi-Cat 2

NDC Product Code

32909-724

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

waterInactive

Code: 059QF0KO0RClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

Readi-Cat 2 Berry Smoothie

NDC Product Code

32909-741

Application Number

NDA208143

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

October 12, 2020

Ingredients

Barium sulfateActive

Code: 25BB7EKE2EClass: ACTIBQuantity: 20 mg in 1 mL

anhydrous citric acidInactive

Code: XF417D3PSLClass: IACT

dimethicone 1000Inactive

Code: MCU2324216Class: IACT

dimethicone 350Inactive

Code: 2Y53S6ATLUClass: IACT

sodium benzoateInactive

Code: OJ245FE5EUClass: IACT

benzoic acidInactive

Code: 8SKN0B0MIMClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

potassium sorbateInactive

Code: 1VPU26JZZ4Class: IACT

sorbitolInactive

Code: 506T60A25RClass: IACT

trisodium citrate dihydrateInactive

Code: B22547B95KClass: IACT

xanthan gumInactive

Code: TTV12P4NEEClass: IACT

saccharin sodiumInactive

Code: SB8ZUX40TYClass: IACT

waterInactive

Code: 059QF0KO0RClass: IACT

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Readi-Cat 2

Registrants (1)

Manufacturing Establishments (1)

Products (10)

Readi-Cat 2 Mochaccino Smoothie

Readi-Cat 2 Creamy Vanilla Smoothie

Readi-Cat 2 Banana Smoothie

Readi-Cat 2 Creamy Vanilla Smoothie

Readi-Cat 2 Mochaccino Smoothie

Readi-Cat 2 Berry Smoothie

Readi-Cat 2 Banana Smoothie

Readi-Cat 2

Readi-Cat 2

Readi-Cat 2 Berry Smoothie