Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216339
Company: ZYDUS WORLDWIDE DMCC
Company: ZYDUS WORLDWIDE DMCC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PALBOCICLIB | PALBOCICLIB | 75MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PALBOCICLIB | PALBOCICLIB | 100MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
PALBOCICLIB | PALBOCICLIB | 125MG | 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 |
---|---|---|---|---|---|---|---|
06/27/2023 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |