FdaApplication
NDA 204781
Identifiers
- fda_app_no: NDA204781
Properties
| Property | Value |
|---|---|
| applicant_name | GUERBET LLC |
| application_type | NDA |
| approval_date | 2013-03-20 |
Products (5)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| DOTAREM | GADOTERATE MEGLUMINE | 1.8845GM/5ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
| DOTAREM | GADOTERATE MEGLUMINE | 7.538GM/20ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
| DOTAREM | GADOTERATE MEGLUMINE | 37.69GM/100ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
| DOTAREM | GADOTERATE MEGLUMINE | 3.769GM/10ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
| DOTAREM | GADOTERATE MEGLUMINE | 5.6535GM/15ML (376.9MG/ML) | SOLUTION;INTRAVENOUS |
5 products