Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 212884
Company: AMNEAL EU LTD
Company: AMNEAL EU LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ELTROMBOPAG | ELTROMBOPAG | 12.5MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| ELTROMBOPAG | ELTROMBOPAG | 25MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| ELTROMBOPAG | ELTROMBOPAG | 50MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| ELTROMBOPAG | ELTROMBOPAG | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |