← FDA Drug Approvals (Drugs@FDA)
AMBELVIST
NDA · New Drug Application · Sponsor: BAYER HEALTHCARE · Approved 2026-06-12
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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