ON TARGET LABROTORIES, INC. FDA Approval NDA 214907

NDA 214907

ON TARGET LABROTORIES, INC.

FDA Drug Application

Application #214907

Documents

Letter2021-11-30
Label2021-11-30
Review2021-12-22

Application Sponsors

NDA 214907ON TARGET LABROTORIES, INC.

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION3.2MG/1.6ML (2MG/ML)0CYTALUXPAFOLACIANINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-11-29PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

ON TARGET LABROTORIES, INC.
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(
    [0] => Array
        (
            [ApplNo] => 214907
            [companyName] => ON TARGET LABROTORIES, INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYTALUX","activeIngredients":"PAFOLACIANINE","strength":"3.2MG\/1.6ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214907s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/214907s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214907Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-29
        )

)

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