PRINSTON INC FDA Approval ANDA 209029

ANDA 209029

PRINSTON INC

FDA Drug Application

Application #209029

Application Sponsors

ANDA 209029PRINSTON INC

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL4MG0SILODOSINSILODOSIN
002CAPSULE;ORAL8MG0SILODOSINSILODOSIN

FDA Submissions

UNKNOWN; ORIG1AP2022-01-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209029
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SILODOSIN","activeIngredients":"SILODOSIN","strength":"8MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/04\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-04
        )

)

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