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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205625
Company: GLAXOSMITHKLINE

Summary Review

Products on NDA 205625

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARNUITY ELLIPTA	FLUTICASONE FUROATE	0.1MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
ARNUITY ELLIPTA	FLUTICASONE FUROATE	0.2MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
ARNUITY ELLIPTA	FLUTICASONE FUROATE	0.05MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205625

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2014	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205625s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205625Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205625Orig1s000TOC.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205625Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205625s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205625Orig1s011ltr.pdf
03/01/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205625s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205625Orig1s009ltr.pdf
01/07/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205625s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205625Orig1s007ltr.pdf
05/17/2018	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205625s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205625Orig1s005ltr.pdf
03/20/2015	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205625Orig1s001Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205625Orig1s001ltr.pdf

Labels for NDA 205625

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205625s011lbl.pdf
03/01/2023	SUPPL-9	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205625s009lbl.pdf
01/07/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205625s007lbl.pdf
05/17/2018	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205625s005lbl.pdf
03/20/2015	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205625Orig1s001Lbl.pdf
08/20/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205625s000lbl.pdf

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