Rybelsus, Ozempic

For type 2 diabetes mellitus. NDA 213051, held by Novo. Semaglutide.

As of Nov 14, 2026, NDA 213051 (Rybelsus, Ozempic), held by Novo, was first approved by FDA on Sep 20, 2019, with 12 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2019
Review: Priority
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

RYBELSUS and OZEMPIC tablets are 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 (CV) events (CV death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Oct 17, 2025	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Letter Label Medication Guide
Dec 9, 2024	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 20, 2019	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Products

6 strengths and forms


Rybelsus3MG · tablet;oral	Semaglutide	RxReference drug
Rybelsus7MG · tablet;oral	Semaglutide	RxReference drug
Rybelsus14MG · tablet;oral	Semaglutide	RxReference drug
Ozempic1.5MG · tablet;oral	Semaglutide	RxReference drug
Ozempic4MG · tablet;oral	Semaglutide	RxReference drug
Ozempic9MG · tablet;oral	Semaglutide	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Jan 30, 2026	Supplement 30Labeling · Standard review	Approved	Label Letter
Oct 17, 2025	Supplement 24Efficacy (new indication or use) · Standard review	Approved	Letter Letter Label Medication Guide
Oct 17, 2025	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 17, 2025	Supplement 29Labeling · Standard review	Approved	Letter Label
Dec 9, 2024	Supplement 20Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 9, 2024	Supplement 21Labeling · Standard review	Approved	Label Letter
Nov 1, 2024	Supplement 23Labeling	Approved	Letter Label
Jan 24, 2024	Supplement 18Labeling · Standard review	Approved	Letter Label
Jan 12, 2023	Supplement 12Labeling · Standard review	Approved	Letter Label
Jun 10, 2022	Supplement 11Labeling	Approved	Label Letter
Apr 30, 2021	Supplement 6Manufacturing	Approved	Label
Jan 16, 2020	Supplement 1Labeling · Standard review	Approved	Label Letter
Sep 20, 2019	Original applicationNew dosage form · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 213051
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