ZYDUS PHARMS FDA Approval ANDA 204816

ANDA 204816

ZYDUS PHARMS

FDA Drug Application

Application #204816

Application Sponsors

ANDA 204816ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL4MG0SILODOSINSILODOSIN
002CAPSULE;ORAL8MG0SILODOSINSILODOSIN

FDA Submissions

UNKNOWN; ORIG1AP2022-12-08STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204816
            [companyName] => ZYDUS PHARMS
            [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":"12\/08\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-12-08
        )

)

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