Drugs@FDA: FDA-Approved Drugs

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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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