# AMBELVIST
> **NDA219627** · New Drug Application · Sponsor: BAYER HEALTHCARE · Approved 2026-06-12
## Drug
- **FDA Application Number:** NDA219627
- **Application type:** New Drug Application
- **Brand name:** AMBELVIST
- **Generic name:** GADOQUATRANE
- **Active ingredients:** GADOQUATRANE
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** BAYER HEALTHCARE
- **Manufacturer:** Bayer HealthCare Pharmaceuticals Inc.
- **First approval:** 2026-06-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219627)
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*MORVS · CC0 1.0*