Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 208036

E-Z-HD (BARIUM SULFATE)
98% (334GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: E-Z-HD
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 98% (334GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208036
Product Number: 001
Approval Date: Jan 11, 2016
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information

E-Z-PAQUE (BARIUM SULFATE)
96% (169GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: E-Z-PAQUE
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 96% (169GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208036
Product Number: 002
Approval Date: Apr 7, 2017
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information

VARIBAR THIN LIQUID (BARIUM SULFATE)
81% (120GM/BOT)
Marketing Status: Prescription

Active Ingredient: BARIUM SULFATE
Proprietary Name: VARIBAR THIN LIQUID
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 81% (120GM/BOT)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208036
Product Number: 004
Approval Date: Apr 30, 2019
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status: Prescription
Patent and Exclusivity Information

E-Z-CAT DRY (BARIUM SULFATE)
40% (9GM/POUCH)
Marketing Status: Discontinued

Active Ingredient: BARIUM SULFATE
Proprietary Name: E-Z-CAT DRY
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 40% (9GM/POUCH)
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N208036
Product Number: 003
Approval Date: Jan 3, 2017
Applicant Holder Full Name: BRACCO DIAGNOSTICS INC
Marketing Status: Discontinued
Patent and Exclusivity Information