Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125496
Company: EUSA PHARMA LIMITED
Company: EUSA PHARMA LIMITED
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SYLVANT | SILTUXIMAB | 100MG | INJECTABLE;INJECTION | Prescription | None | No | No |
SYLVANT | SILTUXIMAB | 400MG | INJECTABLE;INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/23/2014 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125496s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/05/2019 | SUPPL-18 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125496Orig1s018ltr.pdf | |
05/31/2018 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125496s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125496Orig1s013ltr.pdf | |
03/24/2017 | SUPPL-5 | Supplement |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/05/2019 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf | |
12/05/2019 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf | |
05/31/2018 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125496s013lbl.pdf | |
04/23/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf |