NDA 19297, held by Emd Serono. Mitoxantrone Hydrochloride.
As of Nov 14, 2026, NDA 19297 (Novantrone), held by Emd Serono, was first approved by FDA on Dec 23, 1987, with 30 approved supplements and 0 published complete response letters.
| Nov 13, 1996 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Dec 23, 1987 | Original applicationNew molecular entity · Standard review | Approved |
| NovantroneEQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Mitoxantrone Hydrochloride | DiscontinuedReference drug |
| NovantroneEQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Mitoxantrone Hydrochloride | DiscontinuedReference drug |
| NovantroneEQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Mitoxantrone Hydrochloride | DiscontinuedReference drug |
| Mar 23, 2012 | Supplement 35Labeling · Standard review | Approved | |
| Jun 13, 2010 | Supplement 34Labeling · Standard review | Approved | |
| Jun 13, 2010 | Supplement 33Labeling · Standard review | Approved | |
| Feb 11, 2009 | Supplement 31Labeling · Standard review | Approved | |
| Feb 11, 2009 | Supplement 30Labeling · Standard review | Approved | |
| Apr 11, 2007 | Supplement 29Manufacturing · Standard review | Approved | |
| Apr 27, 2005 | Supplement 28Labeling · Standard review | Approved | |
| Jan 13, 2003 | Supplement 27Labeling · Standard review | Approved | |
| Jan 13, 2003 | Supplement 26Labeling · Standard review | Approved | |
| Jan 13, 2003 | Supplement 25Labeling · Standard review | Approved | |
| Feb 20, 2002 | Supplement 24Labeling · Standard review | Approved | |
| Feb 9, 2001 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Jan 31, 2001 | Supplement 22Labeling · Standard review | Approved | None posted |
| Oct 19, 2000 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 4, 2000 | Supplement 21Labeling · Standard review | Approved | |
| Aug 13, 1998 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 8, 1998 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 19, 1997 | Supplement 18Labeling · Standard review | Approved | None posted |
| May 23, 1997 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 8, 1997 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 13, 1996 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Oct 18, 1996 | Supplement 12Labeling · Standard review | Approved | None posted |
| Apr 10, 1995 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Sep 23, 1994 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 15, 1994 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1992 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 26, 1990 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1990 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Feb 22, 1990 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 17, 1988 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 23, 1987 | Original applicationNew molecular entity · 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
