Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 220238
Company: QILU PHARMACEUTICAL CO., LTD.
Company: QILU PHARMACEUTICAL CO., LTD.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ABEMACICLIB | ABEMACICLIB | 200MG | TABLET | None (Tentative Approval) | None | No | No |
| ABEMACICLIB | ABEMACICLIB | 150MG | TABLET | None (Tentative Approval) | None | No | No |
| ABEMACICLIB | ABEMACICLIB | 100MG | TABLET | None (Tentative Approval) | None | No | No |
| ABEMACICLIB | ABEMACICLIB | 50MG | TABLET | 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 |
|---|---|---|---|---|---|---|---|
| 11/06/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |