SCPHARMACEUTICALS INC FDA Approval NDA 209988

NDA 209988

SCPHARMACEUTICALS INC

FDA Drug Application

Application #209988

Documents

Letter2022-10-11
Label2022-10-11

Application Sponsors

NDA 209988SCPHARMACEUTICALS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION80MG/10ML0FUROSCIXFUROSEMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2022-10-07STANDARD

Submissions Property Types

ORIG1Null12

CDER Filings

SCPHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209988
            [companyName] => SCPHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSCIX","activeIngredients":"FUROSEMIDE","strength":"80MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209988s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/07\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209988s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209988Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-10-07
        )

)

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