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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022518
Company: ORGANON LLC

Summary Review

Products on NDA 22518

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.1MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.2MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
DULERA	FORMOTEROL FUMARATE; MOMETASONE FUROATE	0.005MG/INH;0.05MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes

Labels for NDA 022518

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2025	SUPPL-33	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022518Orig1s033lbl.pdf
08/12/2019	SUPPL-26	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022518s026lbl.pdf
03/23/2018	SUPPL-24	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf
03/23/2018	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s024lbl.pdf
03/23/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022518s023s024lbl.pdf
12/20/2017	SUPPL-22	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s022lbl.pdf
06/27/2017	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022518s021lbl.pdf
07/12/2016	SUPPL-19	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf
04/23/2015	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022518s015lbl.pdf
08/21/2013	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s013lbl.pdf
07/30/2013	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf
07/30/2013	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s011lbl.pdf
01/15/2013	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf
01/15/2013	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022518s008lbl.pdf
11/23/2012	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s006lbl.pdf
08/21/2012	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022518s005lbl.pdf
08/18/2011	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf
08/18/2011	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022518s002s004lbl.pdf
06/22/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022518s000lbl.pdf

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