Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 220258
Company: AZURITY
Company: AZURITY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESNIBEN | CABOZANTINIB | 13MG | TABLET; ORAL | Prescription | None | No | No |
| RESNIBEN | CABOZANTINIB | 26MG | TABLET; ORAL | Prescription | None | No | No |
| RESNIBEN | CABOZANTINIB | 39MG | TABLET; 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 |
|---|---|---|---|---|---|---|---|
| 10/24/2025 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/220258Orig1s000TAltr.pdf |