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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205382
Company: GLAXO GRP ENGLAND

Summary Review

Products on NDA 205382

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
INCRUSE ELLIPTA	UMECLIDINIUM BROMIDE	EQ 0.0625MG BASE/INH	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205382

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2014	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/2014/205382s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205382Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205382Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205382s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205382Orig1s013ltr.pdf
06/06/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205382s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205382Orig1s010ltr.pdf
10/20/2017	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205382Orig1s008ltr.pdf
06/13/2017	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205382Orig1s006ltr.pdf
02/24/2016	SUPPL-2	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205382s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205382Orig1s002ltr.pdf

Labels for NDA 205382

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205382s013lbl.pdf
06/06/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205382s010lbl.pdf
10/20/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s008lbl.pdf
06/13/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s006lbl.pdf
02/24/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205382s002lbl.pdf
04/30/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205382s000lbl.pdf

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