← FDA DRUG APPROVALS

FDA NDA · NDA019297

NOVANTRONE

Sponsor: EMD SERONO

APPLICATION
NDA019297
TYPE
NDA
ORIGINAL APPROVAL
1987-12-23
LATEST ACTION
2012-03-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

NOVANTRONE · ReferenceDiscontinued
MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NOVANTRONE · ReferenceDiscontinued
MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
NOVANTRONE · ReferenceDiscontinued
MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2012-03-23Labeling · Supplement 35 · standard — Medication Guide ↗AP
2010-06-13Labeling · Supplement 34 · standard — Letter ↗AP
2010-06-13Labeling · Supplement 33 · standard — Letter ↗AP
2009-02-11Labeling · Supplement 30 · standard — Letter ↗AP
2009-02-11Labeling · Supplement 31 · standard — Label ↗AP
2007-04-11Manufacturing (CMC) · Supplement 29 · standard — Letter ↗AP
2005-04-27Labeling · Supplement 28 · standard — Label ↗AP
2003-01-13Labeling · Supplement 26 · standard — Letter ↗AP
2003-01-13Labeling · Supplement 27 · standard — Letter ↗AP
2003-01-13Labeling · Supplement 25 · standard — Letter ↗AP
2002-02-20Labeling · Supplement 24 · standard — Letter ↗AP
2001-02-09Manufacturing (CMC) · Supplement 23 · standardAP
2001-01-31Labeling · Supplement 22 · standardAP
2000-10-19Manufacturing (CMC) · Supplement 20 · standardAP
2000-02-04Labeling · Supplement 21 · standard — Review ↗AP
1998-08-13Manufacturing (CMC) · Supplement 17 · standardAP
1998-05-08Labeling · Supplement 19 · standardAP
1997-09-19Labeling · Supplement 18 · standardAP
1997-05-23Labeling · Supplement 16 · standardAP
1997-05-08Manufacturing (CMC) · Supplement 15 · standardAP
1996-11-13Efficacy · Supplement 14 · standard — Review ↗AP
1996-10-18Labeling · Supplement 12 · standardAP
1995-04-10Manufacturing (CMC) · Supplement 11 · standardAP
1994-09-23Labeling · Supplement 10 · standardAP
1994-04-15Manufacturing (CMC) · Supplement 9 · standardAP
1992-02-19Manufacturing (CMC) · Supplement 6 · standardAP
1990-11-26Manufacturing (CMC) · Supplement 2 · standardAP
1990-07-30Manufacturing (CMC) · Supplement 8 · standardAP
1990-02-22Manufacturing (CMC) · Supplement 5 · standardAP
1988-03-17Manufacturing (CMC) · Supplement 1 · standardAP
1987-12-23Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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