Gadavist - gadobutrol
Navigation: NDC > Supplier starting with: B > BAYER HEALTHCARE PHARMACEUTICALS INC.| Field | Value |
|---|---|
| NDC Code: | 50419-325 |
| Proprietary Name: | Gadavist |
| Suffix: | |
| Non-Proprietary Name: | gadobutrol |
| Dosage Form: | INJECTION |
| Method: | INTRAVENOUS |
| Original Marketing Date: | 14-03-2011 |
| Category Name: | NDA |
| Application Number: | NDA201277 |
| Labeler: | BAYER HEALTHCARE PHARMACEUTICALS INC. |
| Substance Name: | GADOBUTROL |
| Active Numerator Strength: | 604.72 |
| Active Ingredient Unit: | mg/mL |
| Pharm Classes: | Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA] |
| DEA Schedule: |