Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065343
Company: HOSPIRA
Company: HOSPIRA
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 |
---|---|---|---|---|---|---|---|
04/19/2007 | 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 |
---|---|---|---|---|---|
04/16/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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04/16/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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01/09/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |