Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 215061

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GADOBUTROL (GADOBUTROL)
1.20944GM/2ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADOBUTROL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.20944GM/2ML (604.72MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215061
Product Number: 001
Approval Date: Nov 17, 2022
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GADOBUTROL (GADOBUTROL)
4.5354GM/7.5ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADOBUTROL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4.5354GM/7.5ML (604.72MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215061
Product Number: 002
Approval Date: Nov 17, 2022
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GADOBUTROL (GADOBUTROL)
6.0472GM/10ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADOBUTROL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 6.0472GM/10ML (604.72MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215061
Product Number: 003
Approval Date: Nov 17, 2022
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

GADOBUTROL (GADOBUTROL)
9.0708GM/15ML (604.72MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOBUTROL
Proprietary Name: GADOBUTROL
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 9.0708GM/15ML (604.72MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A215061
Product Number: 004
Approval Date: Nov 17, 2022
Applicant Holder Full Name: JIANGSU HENGRUI PHARMACEUTICALS CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information