← FDA DRUG APPROVALS

FDA NDA · NDA213051

OZEMPIC

oral semaglutide

Sponsor: NOVO

APPLICATION
NDA213051
TYPE
NDA
ORIGINAL APPROVAL
2019-09-20
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OZEMPIC · ReferencePrescription
SEMAGLUTIDE 9MG · TABLET · ORAL
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 1.5MG · TABLET · ORAL
RYBELSUS · ReferencePrescription
SEMAGLUTIDE 7MG · TABLET · ORAL
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 4MG · TABLET · ORAL
RYBELSUS · ReferencePrescription
SEMAGLUTIDE 14MG · TABLET · ORAL
RYBELSUS · ReferencePrescription
SEMAGLUTIDE 3MG · TABLET · ORAL

Approval history

2026-01-30Labeling · Supplement 30 · standard — Letter ↗AP
2025-10-17Labeling · Supplement 29 · standard — Label ↗AP
2025-10-17Labeling · Supplement 28 · standard — Label ↗AP
2025-10-17Efficacy · Supplement 24 · standard — Label ↗AP
2024-12-09Labeling · Supplement 21 · standard — Label ↗AP
2024-12-09Efficacy · Supplement 20 · standard — Label ↗AP
2024-11-01Labeling · Supplement 23 · 901 required — Letter ↗AP
2024-01-24Labeling · Supplement 18 · standard — Letter ↗AP
2023-01-12Labeling · Supplement 12 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 11 · 901 required — Label ↗AP
2021-04-30Manufacturing (CMC) · Supplement 6 — Label ↗AP
2020-01-16Labeling · Supplement 1 · standard — Label ↗AP
2019-09-20Type 3 - New Dosage Form · Original · priority — 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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