ZYDUS PHARMS FDA Approval ANDA 208954

ANDA 208954

ZYDUS PHARMS

FDA Drug Application

Application #208954

Application Sponsors

ANDA 208954ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL375MG0MESALAMINEMESALAMINE

FDA Submissions

UNKNOWN; ORIG1AP2021-08-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208954
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESALAMINE","activeIngredients":"MESALAMINE","strength":"375MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/12\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-12
        )

)

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