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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205641
Company: ORGANON LLC

Summary Review

Products on NDA 205641

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASMANEX HFA	MOMETASONE FUROATE	0.10MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	No
ASMANEX HFA	MOMETASONE FUROATE	0.20MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	Yes
ASMANEX HFA	MOMETASONE FUROATE	0.05MG/INH	AEROSOL, METERED;INHALATION	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205641

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2014	ORIG-1	Approval	Type 2 - New Active Ingredient and Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205641s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205641Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205641Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205641Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205641s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205641Orig1s010ltr.pdf
03/26/2018	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205641Orig1s007s008ltr.pdf
03/26/2018	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205641Orig1s007s008ltr.pdf
07/12/2016	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022518Orig1s019,205641Orig1s005ltr.pdf
08/03/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s004lbl.pdf
06/16/2015	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205641Orig1s002ltr.pdf
08/06/2015	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 205641

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/12/2019	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205641s010lbl.pdf
03/26/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf
03/26/2018	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf
03/26/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf
03/26/2018	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205641s007s008lbl.pdf
07/12/2016	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022518s019,205641s005lbl.pdf
08/03/2015	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s004lbl.pdf
06/16/2015	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205641s002lbl.pdf
04/25/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205641s000lbl.pdf

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