NDA 209310

INTERSECT ENT INC

FDA Drug Application

Application #209310

Documents

• Label: 2017-12-11
• Letter: 2017-12-11
• Label: 2018-01-16
• Letter: 2018-01-17
• Review: 2018-12-13
• Label: 2020-04-29
• Letter: 2023-01-23
• Label: 2023-01-24

Application Sponsors

NDA 209310

INTERSECT ENT INC

Marketing Status

• Prescription: 001

Application Products

001

IMPLANT;IMPLANTATION

1.35MG

1

SINUVA

MOMETASONE FUROATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2017-12-08	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2020-04-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2023-01-20	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	6	Null	6

CDER Filings

INTERSECT ENT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209310
            [companyName] => INTERSECT ENT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SINUVA","activeIngredients":"MOMETASONE FUROATE","strength":"1.35MG","dosageForm":"IMPLANT;IMPLANTATION","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"04\/28\/2020","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209310s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209310s001lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209310s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/08\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209310lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209310lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209310Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209310Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/28\/2020","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209310s003lbl.pdf\"}]","notes":">"},{"actionDate":"01\/12\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209310s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209310Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-28
        )

)