Drug application
GADOBUTROL (GADOBUTROL)
Drugs@FDA ANDA 219287 · VIWIT PHARM
Key facts
| Drug name | GADOBUTROL |
|---|---|
| Active ingredients | GADOBUTROL |
| Application type | ANDA |
| Application number | 219287 |
| Company | VIWIT PHARM |
| Dosage forms | SOLUTION, INTRAVENOUS |
| Strength | 4.5354GM/7.5ML (604.72MG/ML) |
| Marketing status | Prescription |
| TE codes | AP |
| Reference listed drug | No |
| Latest submission status date | Jun 11, 2026 |
At a glance
- 1–9 Submissions
- None Label versions
- 1–9 Products
- 1–9 Therapeutic equivalents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.