Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208619
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 500MG/100ML (5MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1GM/100ML (10MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| LEVETIRACETAM IN SODIUM CHLORIDE | LEVETIRACETAM | 1.5GM/100ML (15MG/ML) | INJECTABLE;INTRAVENOUS | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 01/31/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |