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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216986

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ELUCIREM (GADOPICLENOL)
1.4553GM/3ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1.4553GM/3ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 001
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
ELUCIREM (GADOPICLENOL)
3.63825GM/7.5ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 3.63825GM/7.5ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 002
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
ELUCIREM (GADOPICLENOL)
4.851GM/10ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 4.851GM/10ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 003
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
ELUCIREM (GADOPICLENOL)
7.2765GM/15ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 7.2765GM/15ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 004
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
ELUCIREM (GADOPICLENOL)
14.553GM/30ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 14.553GM/30ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 005
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
ELUCIREM (GADOPICLENOL)
24.255GM/50ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 24.255GM/50ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 006
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
ELUCIREM (GADOPICLENOL)
48.51GM/100ML (485.1MG/ML)
Marketing Status: Prescription
Active Ingredient: GADOPICLENOL
Proprietary Name: ELUCIREM
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 48.51GM/100ML (485.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216986
Product Number: 007
Approval Date: Sep 21, 2022
Applicant Holder Full Name: GUERBET
Marketing Status:  Prescription
Patent and Exclusivity Information
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