Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 217700
Company: DAY ONE BIOPHARMS
Company: DAY ONE BIOPHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OJEMDA | TOVORAFENIB | 100MG | TABLET;ORAL | Prescription | None | Yes | Yes |
OJEMDA | TOVORAFENIB | 25MG/ML | SUSPENSION; ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
04/23/2024 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label is not available on this site. |