Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209022
Company: OPTINOSE US INC
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 |
---|---|---|---|---|---|
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-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
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. |
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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209022s010s011lbl.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 | |
04/23/2020 | 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 |