Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019297
Company: EMD SERONO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NOVANTRONE MITOXANTRONE HYDROCHLORIDE EQ 20MG BASE/10ML (EQ 2MG BASE/ML) INJECTABLE;INJECTION Discontinued None Yes No
NOVANTRONE MITOXANTRONE HYDROCHLORIDE EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
NOVANTRONE MITOXANTRONE HYDROCHLORIDE EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/23/1987 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019297_S000_ORIGINAL_APPROVAL_PKG.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/23/2012 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019297s035ltr.pdf
06/13/2010 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf
06/13/2010 SUPPL-33 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019297s033,s034ltr.pdf
02/11/2009 SUPPL-31 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf
02/11/2009 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019297s030,s031ltr.pdf
04/11/2007 SUPPL-29 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019297s029LTR.pdf
04/27/2005 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019297s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019297s028ltr.pdf
01/13/2003 SUPPL-27 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf
01/13/2003 SUPPL-26 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf
01/13/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19297slr025,026,027ltr.pdf
02/20/2002 SUPPL-24 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19297s24ltr.pdf
02/09/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

01/31/2001 SUPPL-22 Labeling

Label is not available on this site.

02/04/2000 SUPPL-21 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19297-S021_Novantrone.pdf
10/19/2000 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1998 SUPPL-19 Labeling

Label is not available on this site.

09/19/1997 SUPPL-18 Labeling

Label is not available on this site.

08/13/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/23/1997 SUPPL-16 Labeling

Label is not available on this site.

05/08/1997 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1996 SUPPL-14 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019297_s014ap.pdf
10/18/1996 SUPPL-12 Labeling

Label is not available on this site.

04/10/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1994 SUPPL-10 Labeling

Label is not available on this site.

04/15/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1990 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/19/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/22/1990 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/26/1990 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/23/2012 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035lbl.pdf
06/13/2010 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf
06/13/2010 SUPPL-33 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019297s033s034lbl.pdf
02/11/2009 SUPPL-31 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf
02/11/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019297s030s031lbl.pdf
04/27/2005 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019297s028lbl.pdf

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