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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022383
Company: NOVARTIS

Medication Guide

Summary Review

Products on NDA 022383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARCAPTA NEOHALER	INDACATEROL MALEATE	EQ 75MCG BASE	POWDER;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2011	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022383s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022383Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022383s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022383Orig1s009, s010ltr.pdf
07/30/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022383s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022383Orig1s009, s010ltr.pdf
05/29/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022383s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022383Orig1s007ltr.pdf
12/18/2012	SUPPL-5	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf
12/18/2012	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s004,s005ltr.pdf
02/25/2013	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
09/26/2012	SUPPL-2	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022383Orig1s002ltr.pdf

Labels for NDA 022383

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022383s009s010lbl.pdf
07/30/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022383s009s010lbl.pdf
05/29/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022383s007lbl.pdf
09/26/2012	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022383s002lbl.pdf
07/01/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022383s000lbl.pdf

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