Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090181
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
IFOSFAMIDE | IFOSFAMIDE | 1GM/20ML (50MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
IFOSFAMIDE | IFOSFAMIDE | 3GM/60ML (50MG/ML) | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
09/22/2009 | ORIG-1 | Approval |
Label is not available on this site. |