FDA.reportPublic FDA data

Application 209022

Type
NDA
Sponsor
OPTINOSE US INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XHANCEFLUTICASONE PROPIONATESPRAY, METERED;NASAL0.093MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent
71143-375XHANCEfluticasone propionateOptiNose US, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77912SUPPL 2024-03-21
77860SUPPL 2024-03-18
73284SUPPL2023-01-25
73283SUPPL2023-01-25
73274SUPPL2023-01-23
73273SUPPL2023-01-23
67438SUPPL2021-05-07
67319SUPPL2021-05-03
67318SUPPL2021-05-03
62674SUPPL2020-04-24
62657SUPPL2020-04-24
52672ORIG2018-02-20
49846ORIG2017-09-22
49818ORIG2017-09-21