Documents
Application Sponsors
NDA 208627 | SIGA TECHNOLOGIES | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 200MG | 1 | TPOXX | TECOVIRIMAT |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2018-07-13 | PRIORITY |
EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-11-23 | STANDARD |
EFFICACY; Efficacy | SUPPL | 7 | AP | 2022-05-18 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 2 |
SUPPL | 6 | Null | 25 |
SUPPL | 7 | Null | 20 |
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
)
)