The Drugs@FDA application history for NDA 218316 records an original approval action on 22 December 2025, classified as a new dosage form. It identifies Wegovy, semaglutide and oral tablets. This is a product- and application-specific regulatory record, not a general authorization for anything described commercially as an oral peptide.
Read the action date, not the file path
Some linked approval-package and label files sit in a 2026 URL directory. The action table nevertheless dates original approval to 22 December 2025. A URL year, a later label date and the original approval date are different pieces of metadata. Our annual timeline uses the agency’s action date.
The history also lists later labeling actions, including January, February and May 2026 entries. This article verifies the original action and tablet route, not every subsequent label revision. Before making a treatment or counseling decision, retrieve the current applicable full prescribing information rather than assume a December approval captures all later conditions.
The commercial implication is narrower than the slogan
An approved oral formulation changes the set of products patients may ask about. It does not show that another company’s oral, sublingual or compounded formulation has the same approval, exposure, clinical evidence or instructions. It also does not establish current availability, a patient’s insurance coverage or an all-in treatment price.
For a provider directory, tie a claim to the actual product, application, route and source date. An ingredient-level match is not enough to label a marketed formulation FDA approved.
Evidence record
Event date: 2025-12-22. Source review: 2026-10-29. Editorial publication: 2026-10-29. Original source links below retain their publication dates. These dates are not interchangeable. This is targeted source synthesis, not an exhaustive archive or a qualified clinical/legal review.
Revision history
29 October 2026: revised from the original Drugs@FDA application action history, preserving the stable route and December 22, 2025 approval date. Later full-label revisions and independent qualified review remain outstanding. Report a proposed correction through Contact us; do not include patient data.