siltuximab Injection
- Brand(s)
- Sylvant
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Janssen Biotech, Inc. (2015-05-04)
- Oldest Current Product
- 2014-04-01
- License(s)
- BLA
- RxNORM
- INJECTION\SILTUXIMAB
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\SILTUXIMAB
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\SILTUXIMAB
product(s) by strength(s)
siltuximab 100 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 578940420 | Sylvant | BLA | Janssen Biotech, Inc. | 2014-04-23 | SILTUXIMAB | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 125496 | 451f535b-8b6b-4ecf-9f19-d921b72eea39 |
siltuximab 400 mg injection
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 578940421 | Sylvant | BLA | Janssen Biotech, Inc. | 2014-04-01 | SILTUXIMAB | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 125496 | 451f535b-8b6b-4ecf-9f19-d921b72eea39 |
application(s)
| # | id | title | approved | tradenames | fda division |
|---|---|---|---|---|---|
| 1 | 125496 | siltuximab Application | 2014-04-23 | Sylvant | CDER |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 451f535b-8b6b-4ecf-9f19-d921b72eea39 (view SPL) | These highlights do not include all the information needed to use SYLVANT safely and effectively. See full prescribing information for SYLVANT. SYLVANT (siltuximab) for Injection, for Intravenous InfusionInitial U.S. Approval: [2014] | prescription | Human Prescription | Janssen Biotech, Inc. | API MANUFACTURE, MANUFACTURE | 2015-05-04 | 4 | 578940420, 578940421 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII