Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214296
Company: ZYDUS WORLDWIDE DMCC
Company: ZYDUS WORLDWIDE DMCC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IBRUTINIB | IBRUTINIB | 140MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| IBRUTINIB | IBRUTINIB | 280MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| IBRUTINIB | IBRUTINIB | 420MG | TABLET;ORAL | None (Tentative Approval) | None | No | No |
| IBRUTINIB | IBRUTINIB | 560MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/19/2021 | ORIG-1 | Tentative Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214296Orig1s000TAltr.pdf |