Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203975
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANORO ELLIPTA UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE 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
12/18/2013 ORIG-1 Approval Type 1 - New Molecular Entity and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203975s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203975Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203975Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/17/2017 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203975Orig1s007ltr.pdf
03/22/2017 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203975Orig1s005ltr.pdf
02/24/2016 SUPPL-3 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203975s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203975Orig1s003ltr.pdf
08/27/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

08/07/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/17/2017 SUPPL-7 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s007lbl.pdf
10/17/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s007lbl.pdf
03/22/2017 SUPPL-5 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf
03/22/2017 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203975s005lbl.pdf
02/24/2016 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203975s003lbl.pdf
12/18/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203975s000lbl.pdf

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