Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 215508
Company: HIKMA PHARMACEUTICALS USA INC
Company: HIKMA PHARMACEUTICALS USA INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EDARAVONE | EDARAVONE | 30mg/100mL | INJECTION;SOLUTION | None (Tentative Approval) | None | No | No |
EDARAVONE | EDARAVONE | 60mg/100mL | INJECTION;SOLUTION | 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 |
---|---|---|---|---|---|---|---|
01/05/2024 | ORIG-1 | Tentative Approval | STANDARD |
Label is not available on this site. |