Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019297
Company: EMD SERONO
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| EQ 20MG BASE/10ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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| EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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| EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |