NDA 50807, held by Hospira. Epirubicin Hydrochloride.
As of Nov 13, 2026, NDA 50807 (Epirubicin Hydrochloride), held by Hospira, was first approved by FDA on Sep 15, 2006, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epirubicin Hydrochloride50MG/VIAL · powder;intravenous | Epirubicin Hydrochloride | Discontinued |
| Epirubicin Hydrochloride200MG/VIAL · powder;intravenous | Epirubicin Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2013 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 15, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
