Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065408
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 10MG/5ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 50MG/25ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 150MG/75ML (2MG/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
| EPIRUBICIN HYDROCHLORIDE | EPIRUBICIN HYDROCHLORIDE | 200MG/100ML (2MG/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 |
|---|---|---|---|---|---|---|---|
| 10/15/2007 | ORIG-1 | Approval |
Label is not available on this site. |