Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209482
Company: GLAXOSMITHKLINE
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
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
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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