← FDA DRUG APPROVALS

FDA NDA · NDA219627

AMBELVIST

gadoquatrane

Sponsor: BAYER HEALTHCARE

APPLICATION
NDA219627
TYPE
NDA
ORIGINAL APPROVAL
2026-06-12
LATEST ACTION
2026-06-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

AMBELVIST · ReferencePrescription
GADOQUATRANE 7.737GM/30ML (257.9MG/ML) · SOLUTION · INTRAVENOUS
AMBELVIST · ReferencePrescription
GADOQUATRANE 2.579GM/10ML (257.9MG/ML) · SOLUTION · INTRAVENOUS
AMBELVIST · ReferencePrescription
GADOQUATRANE 0.5158GM/2ML (257.9MG/ML) · SOLUTION · INTRAVENOUS
AMBELVIST · ReferencePrescription
GADOQUATRANE 16.7635GM/65ML (257.9MG/ML) · SOLUTION · INTRAVENOUS
AMBELVIST · ReferencePrescription
GADOQUATRANE 3.8685GM/15ML (257.9MG/ML) · SOLUTION · INTRAVENOUS
AMBELVIST · ReferencePrescription
GADOQUATRANE 1.93425GM/7.5ML (257.9MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-06-12Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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