NDA 209988

SCPHARMACEUTICALS INC

FDA Drug Application

Application #209988

Documents

• Letter: 2022-10-11
• Label: 2022-10-11
• Letter: 2022-12-22

Application Sponsors

NDA 209988

SCPHARMACEUTICALS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

80MG/10ML

0

FUROSCIX

FUROSEMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2022-10-07

STANDARD

Submissions Property Types

ORIG

1

Null

12

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
        )

)