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FDA NDA · NDA218316

WEGOVY

Sponsor: NOVO

APPLICATION
NDA218316
TYPE
NDA
ORIGINAL APPROVAL
2025-12-22
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

WEGOVY · ReferencePrescription
SEMAGLUTIDE 9MG · TABLET · ORAL
WEGOVY · ReferencePrescription
SEMAGLUTIDE 1.5MG · TABLET · ORAL
WEGOVY · ReferencePrescription
SEMAGLUTIDE 25MG · TABLET · ORAL
WEGOVY · ReferencePrescription
SEMAGLUTIDE 4MG · TABLET · ORAL

Approval history

2026-06-18Labeling · Supplement 7 · standard — Label ↗AP
2026-05-05Labeling · Supplement 3 · standard — Label ↗AP
2026-03-19Labeling · Supplement 5 · standard — Letter ↗AP
2026-02-25Labeling · Supplement 4 · standard — Letter ↗AP
2026-01-29Labeling · Supplement 2 · standard — Letter ↗AP
2025-12-22Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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