SIGA TECHNOLOGIES FDA Approval NDA 208627

NDA 208627

SIGA TECHNOLOGIES

FDA Drug Application

Application #208627

Documents

Label2018-07-13
Letter2018-07-13
Review2018-08-15
Letter2021-11-24
Label2021-12-02
Label2022-05-19
Letter2022-05-19

Application Sponsors

NDA 208627SIGA TECHNOLOGIES

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL200MG1TPOXXTECOVIRIMAT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2018-07-13PRIORITY
EFFICACY; EfficacySUPPL6AP2021-11-23STANDARD
EFFICACY; EfficacySUPPL7AP2022-05-18STANDARD

Submissions Property Types

ORIG1Null2
SUPPL6Null25
SUPPL7Null20

CDER Filings

SIGA TECHNOLOGIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208627
            [companyName] => SIGA TECHNOLOGIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"TPOXX","activeIngredients":"TECOVIRIMAT","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/18\/2022","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/208627s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/23\/2021","submission":"SUPPL-6","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208627s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208627s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/13\/2018","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\\\/2018\\\/208627s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208627Orig1s000ltr.PDF\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208627Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/18\/2022","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/208627s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/208627Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/23\/2021","submission":"SUPPL-6","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/208627s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208627Orig1s006ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-05-18
        )

)

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