Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217365
Company: CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.
Company: CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PALBOCICLIB CAPSULES | PALBOCICLIB | 75MG | CAPSULE | None (Tentative Approval) | None | No | No |
| PALBOCICLIB CAPSULES | PALBOCICLIB | 125MG | CAPSULE | None (Tentative Approval) | None | No | No |
| PALBOCICLIB CAPSULES | PALBOCICLIB | 100MG | CAPSULE | 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 |
|---|---|---|---|---|---|---|---|
| 11/13/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |