SIGA TECHNOLOGIES FDA Approval NDA 214518

NDA 214518

SIGA TECHNOLOGIES

FDA Drug Application

Application #214518

Documents

Letter2022-05-19
Label2022-05-20

Application Sponsors

NDA 214518SIGA TECHNOLOGIES

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)2TPOXXTECOVIRIMAT

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-05-18STANDARD

Submissions Property Types

ORIG1Null2

TE Codes

001PrescriptionTBD

CDER Filings

SIGA TECHNOLOGIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214518
            [companyName] => SIGA TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"TPOXX","activeIngredients":"TECOVIRIMAT","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214518Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-18
        )

)

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