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GADAVIST (nda201277)- (1.20944GM/2ML (604.72MG/ML),4.5354GM/7.5ML (604.72MG/ML),6.0472GM/10ML (604.72MG/ML),9.0708GM/15ML (604.72MG/ML),18.1416GM/30ML (604.72MG/ML),39.3068GM/65ML (604.72MG/ML))

GADOBUTROL BAYER HLTHCARE
1.20944GM/2ML (604.72MG/ML),4.5354GM/7.5ML (604.72MG/ML),6.0472GM/10ML (604.72MG/ML),9.0708GM/15ML (604.72MG/ML),18.1416GM/30ML (604.72MG/ML),39.3068GM/65ML (604.72MG/ML)
No No
2016-Nov-09 2016-Mar-14
None None
None No
Gadavist is a gadolinium-based contrast agent indicated for use with magnetic resonance imaging (MRI): • To detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in adult and pediatric patients (including term neonates) • To assess the presence and extent of malignant breast disease in adult patients • To evaluate known or suspected supra-aortic or renal artery disease in adult and pediatric patients (including term neonates) • To assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD).
3 0 3
Total Other Developers 4
Drugs with Suitability No
1.20944GM/2ML (604.72MG/ML) ** ** - - -
4.5354GM/7.5ML (604.72MG/ML) ** ** - - -
6.0472GM/10ML (604.72MG/ML) ** ** - - -
9.0708GM/15ML (604.72MG/ML) ** ** - - -
18.1416GM/30ML (604.72MG/ML) ** ** - - -
39.3068GM/65ML (604.72MG/ML) ** ** - - -
NDA Sales Available Total Generic Sales Available
Yes 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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