67684-2000-4 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130426 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
6 VIAL in 1 PACKAGE (67684-2000-4) / 100 mL in 1 VIAL |
67684-2000-0 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20170331 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2000-0) / 5 mL in 1 VIAL |
67684-2000-1 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130320 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2000-1) / 10 mL in 1 VIAL |
67684-2000-2 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130320 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2000-2) / 15 mL in 1 VIAL |
67684-2000-3 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130320 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2000-3) / 20 mL in 1 VIAL |
67684-2000-5 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130320 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
5 SYRINGE in 1 PACKAGE (67684-2000-5) / 10 mL in 1 SYRINGE |
67684-2000-6 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130320 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
5 SYRINGE in 1 PACKAGE (67684-2000-6) / 15 mL in 1 SYRINGE |
67684-2000-7 |
67684-2000 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130320 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
5 SYRINGE in 1 PACKAGE (67684-2000-7) / 20 mL in 1 SYRINGE |
67684-2001-4 |
67684-2001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20130426 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
6 VIAL in 1 PACKAGE (67684-2001-4) / 100 mL in 1 VIAL |
67684-2001-0 |
67684-2001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20191024 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2001-0) / 5 mL in 1 VIAL |
67684-2001-1 |
67684-2001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20191024 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2001-1) / 10 mL in 1 VIAL |
67684-2001-2 |
67684-2001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20191024 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2001-2) / 15 mL in 1 VIAL |
67684-2001-3 |
67684-2001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20191024 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 VIAL in 1 PACKAGE (67684-2001-3) / 20 mL in 1 VIAL |
67684-3001-1 |
67684-3001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20190918 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-1) / 10 mL in 1 SYRINGE, PLASTIC |
67684-3001-2 |
67684-3001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20190918 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-2) / 15 mL in 1 SYRINGE, PLASTIC |
67684-3001-3 |
67684-3001 |
HUMAN PRESCRIPTION DRUG |
DOTAREM |
gadoterate meglumine |
INJECTION |
INTRAVENOUS |
20190918 |
N/A |
NDA |
NDA204781 |
Guerbet LLC |
GADOTERATE MEGLUMINE |
376.9 mg/mL |
10 SYRINGE, PLASTIC in 1 PACKAGE (67684-3001-3) / 20 mL in 1 SYRINGE, PLASTIC |