Ozempic

For type 2 diabetes mellitus. NDA 209637, held by Novo. Semaglutide.

As of Nov 13, 2026, NDA 209637 (Ozempic), held by Novo, was first approved by FDA on Dec 5, 2017, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 5, 2017
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OZEMPIC is indicated:

as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
to reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Jan 28, 2025	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 28, 2022	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 16, 2020	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 5, 2017	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

7 strengths and forms


Ozempic2MG/1.5ML (1.34MG/ML) · solution;subcutaneous	Semaglutide	DiscontinuedReference drug
Ozempic4MG/3ML (1.34MG/ML) · solution;subcutaneous	Semaglutide	RxReference drug
Ozempic8MG/3ML (2.68MG/ML) · solution;subcutaneous	Semaglutide	RxReference drug
Ozempic2MG/3ML (0.68MG/ML) · solution;subcutaneous	Semaglutide	RxReference drug
Ozempic0.25MG/0.5ML (0.25MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Ozempic0.5MG/0.5ML (0.5MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug
Ozempic1MG/0.5ML (1MG/0.5ML) · solution;subcutaneous	Semaglutide	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Aug 27, 2026	Supplement 44Labeling · Standard review	Approved	Letter Label
Jun 1, 2026	Supplement 38Labeling · Standard review	Approved	Label Letter
May 5, 2026	Supplement 39Manufacturing	Approved	Letter Label
Oct 14, 2025	Supplement 35Labeling · Standard review	Approved	Review Letter Label
Oct 14, 2025	Supplement 37Labeling · Standard review	Approved	Review Letter Label Medication Guide
Jan 28, 2025	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 1, 2024	Supplement 32Labeling	Approved	Review Letter Label
Sep 22, 2023	Supplement 20Labeling · Standard review	Approved	Letter Label
Sep 22, 2023	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 6, 2022	Supplement 12Labeling · Standard review	Approved	Label Letter
Mar 28, 2022	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 12, 2021	Supplement 8Labeling · Standard review	Approved	Label Letter
Jan 16, 2020	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 27, 2019	Supplement 4Labeling · Standard review	Approved	Label Letter
Apr 9, 2019	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 5, 2017	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Promotion Letters

OPDP letters about this application's advertising

Untitled letter: OZEMPICFeb 26, 2026

Identifiers

Application: NDA 209637
Drugs@FDA: Overview at FDA
Company: Novo

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters