NDA 021120

SERONO INC

FDA Drug Application

Application #021120

Documents

• Letter: 2004-06-10
• Label: 2004-06-10
• Review: 2004-04-12
• Other Important Information from FDA: 2008-07-29

Application Sponsors

NDA 021120

SERONO INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE; INJECTION

EQ 2MG BASE/ML

0

NOVANTRONE

MITOXANTRONE HYDROCHLORIDE

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2000-10-13

PRIORITY

Submissions Property Types

ORIG

1

Null

0

CDER Filings

SERONO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21120
            [companyName] => SERONO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOVANTRONE","activeIngredients":"MITOXANTRONE HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/13\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2000\\\/21120.pdf_Novantrone_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NOVANTRONE","submission":"MITOXANTRONE HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-10-13
        )

)