FdaApplication
NDA 201277
Identifiers
- fda_app_no: NDA201277
Properties
| Property | Value |
|---|---|
| applicant_name | BAYER HEALTHCARE PHARMACEUTICALS INC |
| application_type | NDA |
| approval_date | 2011-03-14 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| GADAVIST | GADOBUTROL | 1.20944GM/2ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADAVIST | GADOBUTROL | 9.0708GM/15ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADAVIST | GADOBUTROL | 18.1416GM/30ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADAVIST | GADOBUTROL | 4.5354GM/7.5ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADAVIST | GADOBUTROL | 39.3068GM/65ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
| GADAVIST | GADOBUTROL | 6.0472GM/10ML (604.72MG/ML) | SOLUTION;INTRAVENOUS |
6 products