# GADOBUTROL
> **ANDA219146** · Abbreviated New Drug Application (Generic) · Sponsor: ZENARA · Approved 2026-06-08
## Drug
- **FDA Application Number:** ANDA219146
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** GADOBUTROL
- **Generic name:** Gadobutrol
- **Active ingredients:** GADOBUTROL
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** ZENARA
- **First approval:** 2026-06-08
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219146)
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