Documents
Application Sponsors
| BLA 125496 | JANSSEN BIOTECH | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 100MG | 0 | SYLVANT | SILTUXIMAB |
| 002 | INJECTABLE;INJECTION | 400MG | 0 | SYLVANT | SILTUXIMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2014-04-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2017-03-24 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2018-05-31 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2019-12-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 5 | Orphan | 5 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 18 | Orphan | 5 |
CDER Filings
JANSSEN BIOTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 125496
[companyName] => JANSSEN BIOTECH
[docInserts] => ["",""]
[products] => [{"drugName":"SYLVANT","activeIngredients":"SILTUXIMAB","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SYLVANT","activeIngredients":"SILTUXIMAB","strength":"400MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/05\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125496s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/05\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125496s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125496s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125496s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"04\/23\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125496s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125496s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125496Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125496Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"12\/05\/2019","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125496s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125496Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"05\/31\/2018","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125496s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125496Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"03\/24\/2017","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-05
)
)