Documents
Application Sponsors
NDA 209022 | OPTINOSE US INC | |
Marketing Status
Application Products
001 | SPRAY, METERED;NASAL | 0.093MG | 1 | XHANCE | FLUTICASONE PROPIONATE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-09-18 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2019-03-01 | N/A |
LABELING; Labeling | SUPPL | 9 | AP | 2020-04-23 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2021-04-29 | N/A |
LABELING; Labeling | SUPPL | 11 | AP | 2021-04-29 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2023-01-20 | STANDARD |
LABELING; Labeling | SUPPL | 17 | AP | 2023-01-20 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 40 |
SUPPL | 6 | Null | 15 |
SUPPL | 9 | Null | 15 |
SUPPL | 11 | Null | 7 |
SUPPL | 13 | Null | 6 |
SUPPL | 17 | Null | 6 |
CDER Filings
OPTINOSE US INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209022
[companyName] => OPTINOSE US INC
[docInserts] => ["",""]
[products] => [{"drugName":"XHANCE","activeIngredients":"FLUTICASONE PROPIONATE","strength":"0.093MG","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"04\/23\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209022s009lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209022s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209022s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209022s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209022Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209022Orig1s000_revTOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"04\/23\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209022s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209022Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"03\/01\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/19\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-04-23
)
)