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Drugs@FDA: FDA-Approved Drugs

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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

Original Approvals or Tentative Approvals
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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/20/2023 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209310s006lbl.pdf 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		 Note Url
01/20/2023 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209310s006lbl.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 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
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