Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 219660
Company: APOTEX
Company: APOTEX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| Ruxolitinib | Ruxolitinib | 5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| Ruxolitinib | Ruxolitinib | 10MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| Ruxolitinib | Ruxolitinib | 15MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| Ruxolitinib | Ruxolitinib | 2MG | TABLET; ORAL | None (Tentative Approval) | 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 |
|---|---|---|---|---|---|---|---|
| 11/21/2025 | ORIG-1 | Tentative Approval | Type 2 - New Active Ingredient | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/219660Orig1s000TAltr.pdf |