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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209022
Company: OPTINOSE US INC

Products on NDA 209022

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XHANCE	FLUTICASONE PROPIONATE	0.093MG	SPRAY, METERED;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209022

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209022s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209022Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209022Orig1s000_revTOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2024	SUPPL-19	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209022s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209022Orig1s019ltr.pdf
01/20/2023	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209022s013s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209022Orig1s013,s017ltr.pdf
01/20/2023	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209022s013s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209022Orig1s013,s017ltr.pdf
04/29/2021	SUPPL-11	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209022s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209022Orig1s010,s011ltr.pdf
04/29/2021	SUPPL-10	Manufacturing (CMC)-Packaging	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209022Orig1s010,s011ltr.pdf
04/23/2020	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209022s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209022Orig1s009ltr.pdf
03/01/2019	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
03/19/2018	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 209022

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/15/2024	SUPPL-19	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209022s019lbl.pdf
01/20/2023	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209022s013s017lbl.pdf
01/20/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209022s013s017lbl.pdf
01/20/2023	SUPPL-13	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209022s013s017lbl.pdf
04/29/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209022s010s011lbl.pdf
04/29/2021	SUPPL-11	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209022s010s011lbl.pdf
04/29/2021	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209022s010s011lbl.pdf
04/23/2020	SUPPL-9	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209022s009lbl.pdf
04/23/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209022s009lbl.pdf
09/18/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209022s000lbl.pdf

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