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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214271

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IODIXANOL (IODIXANOL)
55%
Marketing Status: Prescription
Active Ingredient: IODIXANOL
Proprietary Name: IODIXANOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 55%
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214271
Product Number: 001
Approval Date: May 19, 2022
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
IODIXANOL (IODIXANOL)
65.2%
Marketing Status: Prescription
Active Ingredient: IODIXANOL
Proprietary Name: IODIXANOL
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 65.2%
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A214271
Product Number: 002
Approval Date: May 19, 2022
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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