Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208143

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ENTERO VU 24% (BARIUM SULFATE)
24% (144GM/600ML)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: ENTERO VU 24%
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 24% (144GM/600ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 008
Approval Date: May 29, 2020
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

LIQUID E-Z-PAQUE (BARIUM SULFATE)
60% (213GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: LIQUID E-Z-PAQUE
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 60% (213GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 003
Approval Date: Mar 1, 2017
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

READI-CAT 2 (BARIUM SULFATE)
2% (9GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: READI-CAT 2
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 2% (9GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 001
Approval Date: Jan 15, 2016
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

READI-CAT 2 SMOOTHIE (BARIUM SULFATE)
2% (9GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: READI-CAT 2 SMOOTHIE
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 2% (9GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 002
Approval Date: Jan 15, 2016
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TAGITOL V (BARIUM SULFATE)
40% (8GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: TAGITOL V
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 40% (8GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 005
Approval Date: Aug 4, 2017
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VARIBAR HONEY (BARIUM SULFATE)
40% (100GM/250ML)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: VARIBAR HONEY
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 40% (100GM/250ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 007
Approval Date: Mar 26, 2018
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VARIBAR NECTAR (BARIUM SULFATE)
40% (96GM/240ML)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: VARIBAR NECTAR
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 40% (96GM/240ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 004
Approval Date: Jul 7, 2017
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

VARIBAR THIN HONEY (BARIUM SULFATE)
40% (100GM/250ML)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: VARIBAR THIN HONEY
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 40% (100GM/250ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208143
Product Number: 006
Approval Date: Jan 23, 2018
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information