SANTEN FDA Approval NDA 215092

NDA 215092

SANTEN

FDA Drug Application

Application #215092

Documents

Label2022-09-23
Letter2022-09-23
Review2022-10-20

Application Sponsors

NDA 215092SANTEN

Marketing Status

Prescription001

Application Products

001SOLUTION;OPHTHALMIC0.002%(0.02MG/ML)0OMLONTIOMIDENEPAG ISOPROPYL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-22STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

SANTEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215092
            [companyName] => SANTEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"OMLONTI","activeIngredients":"OMIDENEPAG ISOPROPYL","strength":"0.002%(0.02MG\/ML)","dosageForm":"SOLUTION;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/22\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215092s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/22\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215092s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215092Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-22
        )

)

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