Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205382
Company: GLAXO GRP ENGLAND
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INCRUSE ELLIPTA UMECLIDINIUM BROMIDE EQ 62.5MCG 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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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