Skip to contentApplication 218316
- Type
- NDA
- Sponsor
- NOVO
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | WEGOVY | SEMAGLUTIDE | TABLET;ORAL | 1.5MG | Yes | Yes |
| 002 | WEGOVY | SEMAGLUTIDE | TABLET;ORAL | 4MG | Yes | Yes |
| 003 | WEGOVY | SEMAGLUTIDE | TABLET;ORAL | 9MG | Yes | Yes |
| 004 | WEGOVY | SEMAGLUTIDE | TABLET;ORAL | 25MG | Yes | Yes |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85893 | SUPPL | 2026-05-12 |
| 85516 | SUPPL | 2026-03-24 |
| 85500 | SUPPL | 2026-03-24 |
| 85453 | SUPPL | 2026-03-23 |
| 85194 | SUPPL | 2026-03-02 |
| 85179 | SUPPL | 2026-02-27 |
| 84941 | SUPPL | 2026-02-05 |
| 84886 | SUPPL | 2026-01-30 |
| 84543 | ORIG | 2025-12-23 |
| 84499 | ORIG | 2025-12-23 |