SARFEZ PHARMACEUTICALS INC FDA Approval NDA 213218

NDA 213218

SARFEZ PHARMACEUTICALS INC

FDA Drug Application

Application #213218

Documents

Letter2021-06-15
Label2021-06-15

Application Sponsors

NDA 213218SARFEZ PHARMACEUTICALS INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET; ORAL20MG0SOAANZTORSEMIDE
002TABLET; ORAL60MG0SOAANZTORSEMIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2021-06-14STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

SARFEZ PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213218
            [companyName] => SARFEZ PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SOAANZ","activeIngredients":"TORSEMIDE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SOAANZ","activeIngredients":"TORSEMIDE","strength":"60MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213218s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213218s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213218Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-14
        )

)

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