Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065445
Company: ACTAVIS TOTOWA
Company: ACTAVIS TOTOWA
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 09/18/2008 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/23/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/24/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |