Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | 1 | NOVANTRONE | MITOXANTRONE HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NOVANTRONE | MITOXANTRONE HYDROCHLORIDE |
| 003 | INJECTABLE;INJECTION | EQ 30MG BASE/15ML (EQ 2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | NOVANTRONE | MITOXANTRONE HYDROCHLORIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1987-12-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1990-11-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1990-02-22 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1992-02-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1990-07-30 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1994-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 1994-09-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-04-10 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 1996-10-18 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 1996-11-13 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1997-05-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 1997-05-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-08-13 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 1997-09-19 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 1998-05-08 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2000-02-04 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2001-01-31 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2001-02-09 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2002-02-20 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2003-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2003-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2003-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2005-04-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2007-04-11 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2009-02-11 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2010-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2010-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2012-03-23 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 14 |
| SUPPL | 2 | Null | 14 |
| SUPPL | 5 | Null | 14 |
| SUPPL | 6 | Null | 14 |
| SUPPL | 8 | Null | 14 |
| SUPPL | 9 | Null | 14 |
| SUPPL | 10 | Null | 14 |
| SUPPL | 11 | Null | 14 |
| SUPPL | 12 | Null | 14 |
| SUPPL | 14 | Null | 14 |
| SUPPL | 15 | Null | 14 |
| SUPPL | 16 | Null | 14 |
| SUPPL | 17 | Null | 14 |
| SUPPL | 18 | Null | 14 |
| SUPPL | 19 | Null | 14 |
| SUPPL | 20 | Null | 14 |
| SUPPL | 21 | Null | 14 |
| SUPPL | 22 | Null | 14 |
| SUPPL | 23 | Null | 14 |
| SUPPL | 24 | Null | 14 |
| SUPPL | 25 | Null | 14 |
| SUPPL | 26 | Null | 14 |
| SUPPL | 27 | Null | 14 |
| SUPPL | 28 | Null | 14 |
| SUPPL | 29 | Null | 14 |
| SUPPL | 30 | Null | 14 |
| SUPPL | 31 | Null | 14 |
| SUPPL | 33 | Null | 14 |
| SUPPL | 34 | Null | 14 |
| SUPPL | 35 | Null | 14 |
CDER Filings
EMD SERONO
cder:Array
(
[0] => Array
(
[ApplNo] => 19297
[companyName] => EMD SERONO
[docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2012\/019297s035mg.pdf"]
[products] => [{"drugName":"NOVANTRONE","activeIngredients":"MITOXANTRONE HYDROCHLORIDE","strength":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NOVANTRONE","activeIngredients":"MITOXANTRONE HYDROCHLORIDE","strength":"EQ 25MG BASE\/12.5ML (EQ 2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"NOVANTRONE","activeIngredients":"MITOXANTRONE HYDROCHLORIDE","strength":"EQ 30MG BASE\/15ML (EQ 2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"03\/23\/2012","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/019297s035lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2010","submission":"SUPPL-34","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019297s033s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/13\/2010","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019297s033s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2009","submission":"SUPPL-31","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019297s030s031lbl.pdf\"}]","notes":""},{"actionDate":"02\/11\/2009","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019297s030s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2005","submission":"SUPPL-28","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019297s028lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"NOVANTRONE","submission":"MITOXANTRONE HYDROCHLORIDE","actionType":"EQ 20MG BASE\/10ML (EQ 2MG BASE\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NOVANTRONE","submission":"MITOXANTRONE HYDROCHLORIDE","actionType":"EQ 25MG BASE\/12.5ML (EQ 2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"NOVANTRONE","submission":"MITOXANTRONE HYDROCHLORIDE","actionType":"EQ 30MG BASE\/15ML (EQ 2MG BASE\/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2012-03-23
)
)