DOTAREM |
204781 |
001 |
NDA |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
37.69GM/100ML (376.9MG/ML) |
Yes
|
Yes
|
2013/03/20
|
2013/03/20
|
GUERBET |
Prescription |
DOTAREM |
204781 |
002 |
NDA |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
3.769GM/10ML (376.9MG/ML) |
Yes
|
Yes
|
2013/03/20
|
2013/03/20
|
GUERBET |
Prescription |
DOTAREM |
204781 |
003 |
NDA |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
5.6535GM/15ML (376.9MG/ML) |
Yes
|
Yes
|
2013/03/20
|
2013/03/20
|
GUERBET |
Prescription |
DOTAREM |
204781 |
004 |
NDA |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
7.538GM/20ML (376.9MG/ML) |
Yes
|
Yes
|
2013/03/20
|
2013/03/20
|
GUERBET |
Prescription |
DOTAREM |
204781 |
005 |
NDA |
GADOTERATE MEGLUMINE |
SOLUTION;INTRAVENOUS |
1.8845GM/5ML (376.9MG/ML) |
Yes
|
Yes
|
2013/03/20
|
2017/03/31
|
GUERBET |
Prescription |