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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021067
Company: ORGANON LLC

Products on NDA 021067

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ASMANEX TWISTHALER	MOMETASONE FUROATE	0.22MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes
ASMANEX TWISTHALER	MOMETASONE FUROATE	0.11MG/INH	POWDER;INHALATION	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021067

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21067ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021067s000_AsmanexTOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2021	SUPPL-32	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021067s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021067Orig1s032ltr.pdf
12/19/2019	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021067s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021067Orig1s029ltr.pdf
03/26/2018	SUPPL-28	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021067Orig1s026s028ltr.pdf
03/26/2018	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021067Orig1s026s028ltr.pdf
12/15/2016	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
08/03/2015	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
09/17/2010	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021067s013ltr.pdf
02/26/2008	SUPPL-7	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s007ltr.pdf
02/01/2008	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021067s003ltr.pdf

Labels for NDA 021067

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2021	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021067s032lbl.pdf
02/16/2021	SUPPL-32	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021067s032lbl.pdf
12/19/2019	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021067s029lbl.pdf
03/26/2018	SUPPL-28	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf
03/26/2018	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf
03/26/2018	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf
03/26/2018	SUPPL-26	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021067s026,s028lbl.pdf
09/17/2010	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021067s013lbl.pdf
02/01/2008	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021067s003lbl.pdf
03/30/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021067lbl.pdf

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