2017 · FDA · United States
Ozempic
Semaglutide · Subcutaneous injection · NDA 209637
Initial type 2 diabetes approval. Later supplements and other presentations require their own records.
PEPTIDE DOSSIER · PRACTICAL TOOLS
FDA product approval history
Explore selected US approval events while keeping ingredients, products and applications distinct.
United States · selected original approval history, checked November 12, 2026. This is not a complete current indication list, a current safety-warning tracker or a statement about compounded versions.
2019 · FDA · United States
Rybelsus
Semaglutide · Oral tablet · NDA 213051
Initial type 2 diabetes approval. Later supplements and other presentations require their own records.
2021 · FDA · United States
Wegovy
Semaglutide · Subcutaneous injection · NDA 215256
Initial chronic weight-management approval. Later supplements and other presentations require their own records.
2022 · FDA · United States
Mounjaro
Tirzepatide · Subcutaneous injection · NDA 215866
Initial type 2 diabetes approval. Later supplements and other presentations require their own records.
2023 · FDA · United States
Zepbound
Tirzepatide · Subcutaneous injection · NDA 217806
Initial chronic weight-management approval. Later supplements and other presentations require their own records.
2024-03-08 · Wegovy cardiovascular indication
FDA added cardiovascular risk reduction for adults with established cardiovascular disease and overweight or obesity. Scope is product and population specific.
FDA announcementIngredient identity is not product approval. A trial registration is not approval. For a product absent from this selected history, search Drugs@FDA directly; absence here is not a status determination.