Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210016

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CLARISCAN (GADOTERATE MEGLUMINE)
7.538GM/20ML (376.9MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: CLARISCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 7.538GM/20ML (376.9MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210016
Product Number: 003
Approval Date: Nov 1, 2019
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

CLARISCAN (GADOTERATE MEGLUMINE)
1.8845GM/5ML (376.9MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: CLARISCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.8845GM/5ML (376.9MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210016
Product Number: 005
Approval Date: Nov 24, 2020
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

CLARISCAN (GADOTERATE MEGLUMINE)
3.769GM/10ML (376.9MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: CLARISCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.769GM/10ML (376.9MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210016
Product Number: 001
Approval Date: Nov 1, 2019
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

CLARISCAN (GADOTERATE MEGLUMINE)
5.6535GM/15ML (376.9MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: CLARISCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5.6535GM/15ML (376.9MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210016
Product Number: 002
Approval Date: Nov 1, 2019
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information

CLARISCAN (GADOTERATE MEGLUMINE)
37.69GM/100ML (376.9MG/ML)
Marketing Status: Prescription

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: CLARISCAN
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 37.69GM/100ML (376.9MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A210016
Product Number: 004
Approval Date: Aug 4, 2020
Applicant Holder Full Name: GE HEALTHCARE
Marketing Status:  Prescription
Patent and Exclusivity Information