NDA 214518

SIGA TECHNOLOGIES

FDA Drug Application

Application #214518

Documents

• Letter: 2022-05-19
• Label: 2022-05-20
• Review: 2022-08-18

Application Sponsors

NDA 214518

SIGA TECHNOLOGIES

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

200MG/20ML (10MG/ML)

2

TPOXX

TECOVIRIMAT

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-05-18

STANDARD

Submissions Property Types

ORIG

1

Null

2

TE Codes

001

Prescription

TBD

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
        )

)