Application 215935
- Type
- NDA
- Sponsor
- CALLIDITAS THERAPEUTICS AB
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TARPEYO | BUDESONIDE | CAPSULE, DELAYED RELEASE;ORAL | 4MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 81749-004 | Tarpeyo | budesonide | Calliditas Therapeutics AB | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 78732 | SUPPL | 2024-07-02 |
| 78659 | SUPPL | 2024-06-06 |
| 77124 | SUPPL | 2023-12-22 |
| 77094 | SUPPL | 2023-12-21 |
| 72430 | ORIG | 2022-10-20 |
| 69708 | ORIG | 2021-12-21 |
| 69697 | ORIG | 2021-12-20 |