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FDA NDA · NDA209637

OZEMPIC

Sponsor: NOVO

APPLICATION
NDA209637
TYPE
NDA
ORIGINAL APPROVAL
2017-12-05
LATEST ACTION
2026-06-01
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

OZEMPIC · ReferencePrescription
SEMAGLUTIDE 8MG/3ML (2.68MG/ML) · SOLUTION · SUBCUTANEOUS
OZEMPIC · ReferenceDiscontinued
SEMAGLUTIDE 2MG/1.5ML (1.34MG/ML) · SOLUTION · SUBCUTANEOUS
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 0.5MG/0.5ML (0.5MG/0.5ML) · SOLUTION · SUBCUTANEOUS
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 2MG/3ML (0.68MG/ML) · SOLUTION · SUBCUTANEOUS
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 4MG/3ML (1.34MG/ML) · SOLUTION · SUBCUTANEOUS
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 1MG/0.5ML (1MG/0.5ML) · SOLUTION · SUBCUTANEOUS
OZEMPIC · ReferencePrescription
SEMAGLUTIDE 0.25MG/0.5ML (0.25MG/0.5ML) · SOLUTION · SUBCUTANEOUS

Approval history

2026-06-01Labeling · Supplement 38 · standard — Letter ↗AP
2025-10-14Labeling · Supplement 37 · standard — Letter ↗AP
2025-10-14Labeling · Supplement 35 · standard — Letter ↗AP
2025-01-28Efficacy · Supplement 25 · standard — Label ↗AP
2024-11-01Labeling · Supplement 32 · 901 required — Letter ↗AP
2023-09-22Labeling · Supplement 21 · standard — Letter ↗AP
2023-09-22Labeling · Supplement 20 · standard — Letter ↗AP
2022-10-06Labeling · Supplement 12 · standard — Letter ↗AP
2022-03-28Efficacy · Supplement 9 · standard — Letter ↗AP
2021-04-12Labeling · Supplement 8 · standard — Letter ↗AP
2020-01-16Efficacy · Supplement 3 · standard — Label ↗AP
2019-11-27Labeling · Supplement 4 · standard — Letter ↗AP
2019-04-09Labeling · Supplement 1 · standard — Label ↗AP
2017-12-05Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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