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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203975
Company: GLAXOSMITHKLINE

Summary Review

Products on NDA 203975

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203975

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
06/02/2023	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203975s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203975Orig1s015ltr.pdf
10/20/2022	SUPPL-13	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203975s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203975Orig1s013ltr.pdf
06/06/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203975Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203975Orig1s010_REPLACEMENTltr.pdf
05/29/2019	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203975s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203975Orig1s009ltr.pdf
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.

Labels for NDA 203975

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203975s015lbl.pdf
10/20/2022	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203975s013lbl.pdf
10/20/2022	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203975s013lbl.pdf
06/06/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203975Orig1s010lbl.pdf
05/29/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203975s009lbl.pdf
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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