ZYDUS FDA Approval ANDA 214295

ANDA 214295

ZYDUS

FDA Drug Application

Application #214295

Application Sponsors

ANDA 214295ZYDUS

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL300MG0URSODIOLURSODIOL

FDA Submissions

UNKNOWN; ORIG1AP2020-10-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214295
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"URSODIOL","activeIngredients":"URSODIOL","strength":"300MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-16
        )

)

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