Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761122
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NUCALA | MEPOLIZUMAB | 100MG/ML | INJECTABLE;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
06/06/2019 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761122Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761122Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/08/2023 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125526Orig1s021;761122Orig1s011Corrected_ltr.pdf | |
01/22/2022 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125526Orig1s019; 761122Orig1s008ltr.pdf | |
07/29/2021 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761122Orig1s006; 125526Orig1s018ltr.pdf | |
09/25/2020 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761122s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761122Orig1s005ltr.pdf | |
09/12/2019 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf | |
09/12/2019 | SUPPL-2 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/08/2023 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125526Orig1s021,761122Orig1s011Corrected_lbl.pdf | |
01/22/2022 | SUPPL-8 | Manufacturing (CMC)-New Strength | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761122s008,125526s019lbl.pdf | |
07/29/2021 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761122s006,125526s018lbl.pdf | |
09/25/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761122s005lbl.pdf | |
09/12/2019 | SUPPL-3 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf | |
09/12/2019 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf | |
09/12/2019 | SUPPL-2 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125526s012,761122s002s003lbl.pdf | |
06/06/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761122s000lbl.pdf |