Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 204275
Company: GLAXO GRP LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BREO ELLIPTA FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 0.1MG/INH;EQ 0.025MG BASE/INH POWDER;INHALATION Prescription None Yes Yes
BREO ELLIPTA FLUTICASONE FUROATE; VILANTEROL TRIFENATATE 0.2MG/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
05/10/2013 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204275Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204275Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/20/2017 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204275Orig1s015ltr.pdf
05/15/2017 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204275Orig1s012ltr.pdf
10/31/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s011ltr.pdf
02/16/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204275Orig1s009ltr.pdf
10/21/2015 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/11/2015 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

09/15/2015 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s004ltr.pdf
03/02/2015 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s002ltr.pdf
04/30/2015 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204275Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/20/2017 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s015lbl.pdf
05/15/2017 SUPPL-12 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204275s012lbl.pdf
10/31/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s011lbl.pdf
02/16/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204275s009lbl.pdf
09/15/2015 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s004lbl.pdf
04/30/2015 SUPPL-1 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s001lbl.pdf
03/02/2015 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204275s002lbl.pdf
05/10/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204275s000lbl.pdf

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