NDA 50467, held by Pfizer. Doxorubicin Hydrochloride.
As of Nov 14, 2026, NDA 50467 (Doxorubicin Hydrochloride), held by Pfizer, was first approved by FDA on Aug 7, 1974, with 71 approved supplements and 0 published complete response letters.
| May 8, 2003 | Supplement 68Efficacy (new indication or use) · Standard review | Approved | |
| Aug 7, 1974 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Doxorubicin Hydrochloride10MG/VIAL · injectable;injection | Doxorubicin Hydrochloride | Discontinued |
| Doxorubicin Hydrochloride50MG/VIAL · injectable;injection | Doxorubicin Hydrochloride | Discontinued |
| Doxorubicin Hydrochloride20MG/VIAL · injectable;injection | Doxorubicin Hydrochloride | Discontinued |
| Doxorubicin Hydrochloride150MG/VIAL · injectable;injection | Doxorubicin Hydrochloride | Discontinued |
| Aug 28, 2020 | Supplement 78Labeling · Standard review | Approved | |
| Dec 20, 2019 | Supplement 76Labeling · Standard review | Approved | |
| Aug 9, 2019 | Supplement 77Labeling · Standard review | Approved | |
| Sep 10, 2015 | Supplement 75Manufacturing · Priority review | Approved | None posted |
| Oct 31, 2013 | Supplement 73Labeling · Standard review | Approved | |
| Oct 10, 2013 | Supplement 74Manufacturing · Priority review | Approved | None posted |
| Sep 26, 2011 | Supplement 71Labeling | Approved | |
| Jul 30, 2010 | Supplement 70Labeling | Approved | |
| May 8, 2003 | Supplement 69Labeling · Standard review | Approved | |
| May 8, 2003 | Supplement 68Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2002 | Supplement 67Labeling · Standard review | Approved | |
| Sep 25, 2002 | Supplement 64Labeling · Standard review | Approved | |
| Apr 2, 2002 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Jan 10, 2002 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Mar 4, 1999 | Supplement 63Labeling · Standard review | Approved | None posted |
| Feb 13, 1998 | Supplement 62Labeling · Standard review | Approved | None posted |
| Oct 14, 1997 | Supplement 61Manufacturing · Priority review | Approved | None posted |
| May 3, 1996 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| Apr 26, 1995 | Supplement 59Manufacturing · Priority review | Approved | None posted |
| Nov 29, 1994 | Supplement 2Labeling | Approved | None posted |
| Mar 25, 1988 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Dec 30, 1987 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Jul 22, 1987 | Supplement 55Labeling | Approved | None posted |
| Jul 22, 1987 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Apr 28, 1987 | Supplement 53Labeling | Approved | None posted |
| Mar 27, 1987 | Supplement 50Labeling | Approved | None posted |
| Mar 25, 1987 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Mar 25, 1987 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Feb 19, 1987 | Supplement 52Labeling | Approved | None posted |
| Nov 6, 1986 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| May 21, 1986 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Mar 21, 1986 | Supplement 45Labeling | Approved | None posted |
| Feb 11, 1986 | Supplement 44Labeling | Approved | None posted |
| Jun 7, 1985 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| May 20, 1985 | Supplement 41Labeling | Approved | None posted |
| Mar 4, 1985 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jan 16, 1985 | Supplement 39Manufacturing · Priority review | Approved | None posted |
| Aug 25, 1983 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Aug 10, 1983 | Supplement 36Labeling | Approved | None posted |
| Feb 24, 1983 | Supplement 35Labeling | Approved | None posted |
| Mar 15, 1982 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Mar 15, 1982 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Jul 28, 1981 | Supplement 32Labeling | Approved | None posted |
| Mar 31, 1980 | Supplement 30Labeling | Approved | None posted |
| Oct 31, 1979 | Supplement 29Labeling | Approved | None posted |
| Oct 30, 1979 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1979 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| Mar 14, 1979 | Supplement 26Labeling | Approved | None posted |
| Dec 7, 1978 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Nov 28, 1978 | Supplement 24Labeling | Approved | None posted |
| Sep 13, 1978 | Supplement 22Labeling | Approved | None posted |
| Jul 3, 1978 | Supplement 23Labeling | Approved | None posted |
| Jan 9, 1978 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Aug 18, 1977 | Supplement 20Labeling | Approved | None posted |
| Aug 10, 1977 | Supplement 19Labeling | Approved | None posted |
| Jul 25, 1977 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Jul 25, 1977 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jul 25, 1977 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Mar 29, 1977 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Mar 22, 1977 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Mar 22, 1977 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jan 13, 1977 | Supplement 12Labeling | Approved | None posted |
| Dec 21, 1976 | Supplement 11Labeling | Approved | None posted |
| Sep 14, 1976 | Supplement 10Labeling | Approved | None posted |
| Mar 25, 1976 | Supplement 9Labeling | Approved | None posted |
| Nov 25, 1975 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Oct 16, 1975 | Supplement 7Labeling | Approved | None posted |
| Aug 25, 1975 | Supplement 6Labeling | Approved | None posted |
| May 12, 1975 | Supplement 5Labeling | Approved | None posted |
| May 5, 1975 | Supplement 4Labeling | Approved | None posted |
| Nov 13, 1974 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 7, 1974 | 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
