Documents
Application Sponsors
| BLA 125019 | SPECTRUM PHARMS | |
Marketing Status
Application Products
| 001 | INJECTABLE; INJECTION | 3.2MG/2ML | 0 | ZEVALIN | IBRITUMOMAB TIUXETAN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2002-02-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2003-01-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 58 | AP | 2004-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 70 | AP | 2004-10-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 88 | AP | 2005-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 92 | AP | 2005-09-13 | STANDARD |
| LABELING; Labeling | SUPPL | 117 | AP | 2007-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 132 | AP | 2007-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 135 | AP | 2008-03-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 156 | AP | 2009-09-03 | PRIORITY |
| LABELING; Labeling | SUPPL | 185 | AP | 2010-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 194 | AP | 2011-11-18 | STANDARD |
| LABELING; Labeling | SUPPL | 210 | AP | 2013-08-30 | |
| LABELING; Labeling | SUPPL | 213 | AP | 2013-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 227 | AP | 2018-12-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 27 |
| SUPPL | 58 | Orphan | 5 |
| SUPPL | 88 | Orphan | 5 |
| SUPPL | 156 | Orphan | 5 |
| SUPPL | 210 | Null | 0 |
| SUPPL | 227 | Null | 15 |
CDER Filings
SPECTRUM PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 125019
[companyName] => SPECTRUM PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ZEVALIN","activeIngredients":"IBRITUMOMAB TIUXETAN","strength":"3.2MG\/2ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/11\/2018","submission":"SUPPL-227","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125019s227lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2013","submission":"SUPPL-213","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125019s210s213lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2013","submission":"SUPPL-210","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125019s210s213lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"SUPPL-194","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125019s0194lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2009","submission":"SUPPL-156","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125019s0156.pdf\"}]","notes":""},{"actionDate":"03\/25\/2008","submission":"SUPPL-135","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125019s135lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2007","submission":"SUPPL-132","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125019s132lbl.pdf\"}]","notes":""},{"actionDate":"09\/13\/2005","submission":"SUPPL-92","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125019_0092lbl.pdf\"}]","notes":""},{"actionDate":"07\/27\/2005","submission":"SUPPL-88","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125019_0088lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2004","submission":"SUPPL-70","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125019_0070lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2004","submission":"SUPPL-58","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125019_0058lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ibriide021902LB.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/19\/2002","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ibriide021902LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/ibriide021902L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2002\\\/125019_0000_ZevalinTOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/11\/2018","submission":"SUPPL-227","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125019s227lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125019Orig1s227ltr.pdf\"}]","notes":">"},{"actionDate":"08\/30\/2013","submission":"SUPPL-213","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125019s210s213lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125019Orig1s210,s213ltr.pdf\"}]","notes":">"},{"actionDate":"08\/30\/2013","submission":"SUPPL-210","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125019s210s213lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125019Orig1s210,s213ltr.pdf\"}]","notes":">"},{"actionDate":"11\/18\/2011","submission":"SUPPL-194","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125019s0194lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125019s0194ltr.pdf\"}]","notes":">"},{"actionDate":"12\/16\/2010","submission":"SUPPL-185","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/03\/2009","submission":"SUPPL-156","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125019s0156.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125019s0156ltr.pdf\"}]","notes":">"},{"actionDate":"03\/25\/2008","submission":"SUPPL-135","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125019s135lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125019s0135ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2007","submission":"SUPPL-132","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125019s132lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/125019s132ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2007","submission":"SUPPL-117","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/13\/2005","submission":"SUPPL-92","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125019_0092lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/125019_0092ltr.pdf\"}]","notes":">"},{"actionDate":"07\/27\/2005","submission":"SUPPL-88","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/125019_0088lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/125019_0088ltr.pdf\"}]","notes":">"},{"actionDate":"10\/29\/2004","submission":"SUPPL-70","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125019_0070lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/125019_0070ltr.pdf\"}]","notes":">"},{"actionDate":"10\/22\/2004","submission":"SUPPL-58","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/125019_0058lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/125019_0058ltr.pdf\"}]","notes":">"},{"actionDate":"01\/30\/2003","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-12-11
)
)