Application 215256
- Type
- NDA
- Sponsor
- NOVO NORDISK INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | WEGOVY | SEMAGLUTIDE | INJECTABLE;INJECTION | 0.25MG | No | No |
| 002 | WEGOVY | SEMAGLUTIDE | INJECTABLE;INJECTION | 0.5MG | No | No |
| 003 | WEGOVY | SEMAGLUTIDE | INJECTABLE;INJECTION | 1MG | No | No |
| 004 | WEGOVY | SEMAGLUTIDE | INJECTABLE;INJECTION | 1.7MG | No | No |
| 005 | WEGOVY | SEMAGLUTIDE | INJECTABLE;INJECTION | 2.4MG | No | No |
| 006 | WEGOVY HD | SEMAGLUTIDE | SOLUTION;SUBCUTANEOUS | 7.2MG/0.75ML (7.2MG/0.75ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0169-4501 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4501 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4501 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4505 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4505 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4505 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4517 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4517 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4517 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4524 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4524 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4524 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4525 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4525 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 0169-4525 | WEGOVY | semaglutide | Novo Nordisk | NDA | Current |
| 50090-5824 | WEGOVY | semaglutide | A-S Medication Solutions | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85892 | SUPPL | 2026-05-12 |
| 85515 | SUPPL | 2026-03-24 |
| 85499 | SUPPL | 2026-03-24 |
| 85452 | SUPPL | 2026-03-23 |
| 85190 | SUPPL | 2026-03-02 |
| 85178 | SUPPL | 2026-02-27 |
| 84885 | SUPPL | 2026-01-30 |
| 84943 | SUPPL | 2026-01-29 |
| 84296 | SUPPL | 2025-11-25 |
| 84279 | SUPPL | 2025-11-24 |
| 83779 | SUPPL | 2025-10-15 |
| 83774 | SUPPL | 2025-10-15 |
| 83118 | SUPPL | 2025-08-18 |
| 83106 | SUPPL | 2025-08-15 |
| 80472 | SUPPL | 2024-12-03 |
| 80452 | SUPPL | 2024-11-29 |
| 80167 | SUPPL | 2024-11-05 |
| 80134 | SUPPL | 2024-11-05 |
| 80129 | SUPPL | 2024-11-05 |
| 77775 | SUPPL | 2024-03-11 |
| 77770 | SUPPL | 2024-03-08 |
| 74874 | SUPPL | 2023-07-24 |
| 74868 | SUPPL | 2023-07-24 |
| 73508 | SUPPL | 2023-02-16 |
| 73507 | SUPPL | 2023-02-15 |
| 73054 | SUPPL | 2022-12-27 |
| 73037 | SUPPL | 2022-12-27 |
| 73036 | SUPPL | 2022-12-27 |
| 71941 | SUPPL | 2022-08-29 |
| 69772 | ORIG | 2021-12-27 |
| 67729 | ORIG | 2021-06-07 |
| 67725 | ORIG | 2021-06-07 |
| 67724 | ORIG | 2021-06-07 |