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FDA NDA · NDA216986

VUEWAY

gadopiclenol

Sponsor: GUERBET

APPLICATION
NDA216986
TYPE
NDA
ORIGINAL APPROVAL
2022-09-21
LATEST ACTION
2026-02-20
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ELUCIREM · ReferencePrescription
GADOPICLENOL 24.255GM/50ML (485.1MG/ML) · SOLUTION · INTRAVENOUS
ELUCIREM · ReferencePrescription
GADOPICLENOL 7.2765GM/15ML (485.1MG/ML) · SOLUTION · INTRAVENOUS
ELUCIREM · ReferencePrescription
GADOPICLENOL 3.63825GM/7.5ML (485.1MG/ML) · SOLUTION · INTRAVENOUS
ELUCIREM · ReferencePrescription
GADOPICLENOL 48.51GM/100ML (485.1MG/ML) · SOLUTION · INTRAVENOUS
ELUCIREM · ReferencePrescription
GADOPICLENOL 14.553GM/30ML (485.1MG/ML) · SOLUTION · INTRAVENOUS
ELUCIREM · ReferencePrescription
GADOPICLENOL 4.851GM/10ML (485.1MG/ML) · SOLUTION · INTRAVENOUS
ELUCIREM · ReferencePrescription
GADOPICLENOL 1.4553GM/3ML (485.1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-02-20Efficacy · Supplement 9 · standard — Letter ↗AP
2025-03-05Labeling · Supplement 6 · standard — Letter ↗AP
2024-08-14Labeling · Supplement 3 · standard — Letter ↗AP
2024-07-23Labeling · Supplement 5 · standard — Label ↗AP
2024-01-26Labeling · Supplement 2 · standard — Label ↗AP
2022-09-21Type 1 - New Molecular Entity and Type 4 - New Combination · Original · priority — Label ↗AP
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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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