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ELUCIREM (NDA216986)- (1.4553GM/3ML (485.1MG/ML),3.63825GM/7.5ML (485.1MG/ML),4.851GM/10ML (485.1MG/ML),7.2765GM/15ML (485.1MG/ML),14.553GM/30ML (485.1MG/ML),24.255GM/50ML (485.1MG/ML),48.51GM/100ML (485.1MG/ML))

GADOPICLENOL GUERBET
1.4553GM/3ML (485.1MG/ML),3.63825GM/7.5ML (485.1MG/ML),4.851GM/10ML (485.1MG/ML),7.2765GM/15ML (485.1MG/ML),14.553GM/30ML (485.1MG/ML),24.255GM/50ML (485.1MG/ML),48.51GM/100ML (485.1MG/ML)
No No
2040-Jan-17 2027-Sep-21
None None
None No
ELUCIREM is a gadolinium-based contrast agent indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: • the central nervous system (brain, spine, and associated tissues), • the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).
0 0 0
Total Other Developers None
Drugs with Suitability No
1.4553GM/3ML (485.1MG/ML) ** ** - - -
3.63825GM/7.5ML (485.1MG/ML) ** ** - - -
4.851GM/10ML (485.1MG/ML) ** ** - - -
7.2765GM/15ML (485.1MG/ML) ** ** - - -
14.553GM/30ML (485.1MG/ML) ** ** - - -
24.255GM/50ML (485.1MG/ML) ** ** - - -
48.51GM/100ML (485.1MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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