Application 213716
- Type
- NDA
- Sponsor
- AURINIA PHARMACEUTICALS, INC.
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LUPKYNIS | VOCLOSPORIN | CAPSULE; ORAL | 7.9MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75626-001 | LUPKYNIS | Voclosporin | Aurinia Pharma U.S., Inc. | NDA | Current |
| 75626-001 | LUPKYNIS | Voclosporin | Aurinia Pharma U.S., Inc. | NDA | Current |
| 75626-001 | LUPKYNIS | Voclosporin | Aurinia Pharma U.S., Inc. | NDA | Current |
| 75626-001 | LUPKYNIS | Voclosporin | Aurinia Pharma U.S., Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 83701 | SUPPL | 2025-10-09 |
| 83696 | SUPPL | 2025-10-09 |
| 83695 | SUPPL | 2025-10-09 |
| 78322 | SUPPL | 2024-04-30 |
| 78308 | SUPPL | 2024-04-30 |
| 66342 | ORIG | 2021-02-24 |
| 66003 | ORIG | 2021-01-27 |
| 66002 | ORIG | 2021-01-27 |
| 65974 | ORIG | 2021-01-25 |