NDA 209022

OPTINOSE US INC

FDA Drug Application

Application #209022

Documents

• Label: 2017-09-21
• Letter: 2017-09-22
• Review: 2018-02-20
• Label: 2020-04-24
• Letter: 2020-04-24
• Letter: 2021-05-03
• Label: 2021-05-03
• Label: 2021-05-07
• Letter: 2023-01-23
• Letter: 2023-01-23
• Label: 2023-01-25
• Label: 2023-01-25

Application Sponsors

NDA 209022

OPTINOSE US INC

Marketing Status

• Prescription: 001

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

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            [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":""}]
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            [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
        )

)