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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209482
Company: GLAXOSMITHKLINE

Medication Guide

Products on NDA 209482

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209482

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

Labels for NDA 209482

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

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