Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209482
Company: GLAXOSMITHKLINE
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRELEGY ELLIPTA | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | 0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | POWDER;INHALATION | Prescription | None | Yes | Yes |
TRELEGY ELLIPTA | FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE | 0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH | POWDER;INHALATION | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/18/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209482Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209482Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/02/2023 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209482s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209482Orig1s018ltr.pdf | |
12/02/2022 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209482s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209482Orig1s016ltr.pdf | |
05/11/2022 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209482s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209482Orig1s013ltr.pdf | |
09/09/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209482s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209482Orig1s010, s011ltr.pdf | |
09/09/2020 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209482s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209482Orig1s010, s011ltr.pdf | |
05/15/2019 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209482s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209482Orig1s005ltr.pdf | |
01/07/2019 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209482s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209482Orig1s003ltr.pdf | |
01/07/2019 | SUPPL-2 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209482s002lbl.pdf | ||
04/24/2018 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209482s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209482Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/02/2023 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209482s018lbl.pdf | |
12/02/2022 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209482s016lbl.pdf | |
05/11/2022 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209482s013lbl.pdf | |
09/09/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209482s010s011lbl.pdf | |
09/09/2020 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209482s010s011lbl.pdf | |
05/15/2019 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209482s005lbl.pdf | |
01/07/2019 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209482s003lbl.pdf | |
01/07/2019 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209482s002lbl.pdf | |
04/24/2018 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209482s001lbl.pdf | |
09/18/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209482s000lbl.pdf |