New Drug Application (NDA): 213716
Company: AURINIA PHARMACEUTICALS, INC.
Company: AURINIA PHARMACEUTICALS, INC.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUPKYNIS | VOCLOSPORIN | 7.9MG | CAPSULE; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/22/2021 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213716Orig1s000ltr.pdf |