New Drug Application (NDA): 209310
Company: INTERSECT ENT INC

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SINUVA	MOMETASONE FUROATE	1.35MG	IMPLANT;IMPLANTATION	Prescription	None	Yes	No

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/08/2017	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209310lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209310Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209310Orig1s000TOC.cfm

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/20/2023	SUPPL-6	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209310Orig1s006ltr.pdf
04/28/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209310s003lbl.pdf
01/12/2018	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209310s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209310Orig1s001ltr.pdf

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
04/28/2020	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209310s003lbl.pdf
01/12/2018	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209310s001lbl.pdf
01/12/2018	SUPPL-1	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209310s001lbl.pdf
12/08/2017	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209310lbl.pdf