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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207930
Company: NOVARTIS

Products on NDA 207930

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
UTIBRON	GLYCOPYRROLATE; INDACATEROL MALEATE	15.6MCG/INH;27.5MCG/INH	POWDER;INHALATION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207930

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2015	ORIG-1	Approval	Type 3 - New Dosage Form and Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207930s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207930Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207930Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207930s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207930Orig1s005, s006ltr.pdf
07/30/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207930s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207930Orig1s005, s006ltr.pdf
05/29/2019	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207930s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207930Orig1s004ltr.pdf
01/25/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207930s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207930Orig1s002ltr.pdf
05/11/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207930

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/30/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207930s005s006lbl.pdf
07/30/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207930s005s006lbl.pdf
05/29/2019	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207930s004lbl.pdf
01/25/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207930s002lbl.pdf
10/29/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207930s000lbl.pdf

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