NDA 50731, held by Hikma. Daunorubicin Hydrochloride.
As of Nov 13, 2026, NDA 50731 (Daunorubicin Hydrochloride), held by Hikma, was first approved by FDA on Jan 30, 1998, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Daunorubicin HydrochlorideEQ 5MG BASE/ML · injectable;injection | Daunorubicin Hydrochloride | RxReference drug |
| Sep 27, 2018 | Supplement 8 | Approved | |
| Jun 12, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 2, 2001 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 29, 1999 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1998 | Original applicationNew dosage form · 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
