Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761043
Company: GLAXOSMITHKLINE LLC
Company: GLAXOSMITHKLINE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENLYSTA | BELIMUMAB | 200MG/ML | 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 |
---|---|---|---|---|---|---|---|
07/20/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761043Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761043Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/09/2024 | SUPPL-28 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s082,761043s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125370Orig1s082; 761043Orig1s028ltr.pdf | |
05/16/2024 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761043s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761043Orig1s027ltr.pdf | |
02/15/2023 | SUPPL-22 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125370Orig1s079;761043Orig1s022ltr.pdf | |
07/26/2022 | SUPPL-21 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761043s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761043Orig1s021ltr.pdf | |
12/16/2020 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s073_761043Orig1s013ltr.pdf | |
01/17/2020 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125370Orig1s068, 761043Orig1s008ltr.pdf | |
04/26/2019 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s064; 761043Orig1s007_REPLACEMENTltr.pdf | |
09/13/2019 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125370Orig1s067, 761043Orig1s005ltr.pdf | |
06/22/2018 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125370Orig1s062_761043Orig1s002 Ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/16/2024 | SUPPL-27 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761043s027lbl.pdf | |
02/09/2024 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125370s082,761043s028lbl.pdf | |
02/15/2023 | SUPPL-22 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125370s079,761043s022lbl.pdf | |
07/26/2022 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761043s021lbl.pdf | |
12/16/2020 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s073,761043s013lbl.pdf | |
01/17/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125370s068,761043s008lbl.pdf | |
09/13/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s067,761043s005lbl.pdf | |
04/26/2019 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125370s064,761043s007lbl.pdf | |
06/22/2018 | SUPPL-2 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
06/22/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
06/22/2018 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125370s062,761043s002lbl.pdf | |
07/20/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761043lbl.pdf |