Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204781

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

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: DOTAREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 37.69GM/100ML (376.9MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204781
Product Number: 001
Approval Date: Mar 20, 2013
Applicant Holder Full Name: GUERBET LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: DOTAREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.8845GM/5ML (376.9MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204781
Product Number: 005
Approval Date: Mar 31, 2017
Applicant Holder Full Name: GUERBET LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: DOTAREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.769GM/10ML (376.9MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204781
Product Number: 002
Approval Date: Mar 20, 2013
Applicant Holder Full Name: GUERBET LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: DOTAREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 5.6535GM/15ML (376.9MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204781
Product Number: 003
Approval Date: Mar 20, 2013
Applicant Holder Full Name: GUERBET LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: GADOTERATE MEGLUMINE
Proprietary Name: DOTAREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 7.538GM/20ML (376.9MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N204781
Product Number: 004
Approval Date: Mar 20, 2013
Applicant Holder Full Name: GUERBET LLC
Marketing Status:  Prescription
Patent and Exclusivity Information