THERAGNOSTICS INC FDA Approval NDA 214993

NDA 214993

THERAGNOSTICS INC

FDA Drug Application

Application #214993

Documents

Letter2022-02-22
Label2022-02-22

Application Sponsors

NDA 214993THERAGNOSTICS INC

Marketing Status

Prescription001

Application Products

001POWDER;INTRAVENOUSN/A2NEPHROSCANTECHNETIUM TC-99M SUCCIMER KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-02-18PRIORITY

Submissions Property Types

ORIG1Null6

TE Codes

001PrescriptionTBD

CDER Filings

THERAGNOSTICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214993
            [companyName] => THERAGNOSTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEPHROSCAN","activeIngredients":"TECHNETIUM TC-99M SUCCIMER KIT","strength":"N\/A","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/18\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214993s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214993s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214993Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-02-18
        )

)

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