NDA 50661, held by Pfizer. Idarubicin Hydrochloride.
As of Nov 14, 2026, NDA 50661 (Idamycin), held by Pfizer, was first approved by FDA on Sep 27, 1990, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 1990 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Idamycin10MG/VIAL · powder;intravenous | Idarubicin Hydrochloride | Discontinued |
| Idamycin5MG/VIAL · powder;intravenous | Idarubicin Hydrochloride | Discontinued |
| Idamycin20MG/VIAL · powder;intravenous | Idarubicin Hydrochloride | Discontinued |
| Apr 27, 2022 | Supplement 17Labeling · Standard review | Approved | |
| Feb 10, 2021 | Supplement 16Labeling · Standard review | Approved | |
| Aug 2, 2019 | Supplement 15Labeling · Standard review | Approved | |
| Dec 4, 2014 | Supplement 14Labeling · Standard review | Approved | |
| Oct 11, 2002 | Supplement 8Labeling · Standard review | Approved | |
| Sep 30, 2002 | Supplement 7Labeling · Standard review | Approved | |
| Apr 2, 2002 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Nov 21, 2000 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Apr 7, 2000 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Apr 22, 1998 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Sep 11, 1997 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Sep 17, 1996 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Apr 25, 1995 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jun 29, 1993 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jan 7, 1991 | Supplement 1Labeling | Approved | None posted |
| Sep 27, 1990 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
