Application 213051
- Type
- NDA
- Sponsor
- NOVO
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 3MG | Yes | No |
| 002 | RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 7MG | Yes | No |
| 003 | RYBELSUS | SEMAGLUTIDE | TABLET;ORAL | 14MG | Yes | Yes |
| 004 | OZEMPIC | SEMAGLUTIDE | TABLET;ORAL | 1.5MG | Yes | Yes |
| 005 | OZEMPIC | SEMAGLUTIDE | TABLET;ORAL | 4MG | Yes | Yes |
| 006 | OZEMPIC | SEMAGLUTIDE | TABLET;ORAL | 9MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0169-4303 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4303 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4303 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4303 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4303 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4303 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4307 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4307 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4307 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4307 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4307 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4307 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4314 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4314 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4314 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4314 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4314 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |
| 0169-4314 | RYBELSUS | Oral Semaglutide | Novo Nordisk | NDA | Current |