Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 219117
Company: LANNETT CO INC
Company: LANNETT CO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SELEXIPAG | SELEXIPAG | 1400UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1200UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 400UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1000UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 1600UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 800UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 600UG | TABLET | None (Tentative Approval) | None | No | No |
| SELEXIPAG | SELEXIPAG | 200UG | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/2025 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |