Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078606
Company: FRESENIUS KABI ONCOL
Company: FRESENIUS KABI ONCOL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | EQ 30MG BASE/15ML (EQ 2MG BASE/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 |
|---|---|---|---|---|---|---|---|
| 05/14/2008 | ORIG-1 | Approval |
Label is not available on this site. |