UNICHEM FDA Approval ANDA 213834

ANDA 213834

UNICHEM

FDA Drug Application

Application #213834

Application Sponsors

ANDA 213834UNICHEM

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG EXTENDED0EXTENDED PHENYTOIN SODIUMPHENYTOIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2022-10-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

UNICHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213834
            [companyName] => UNICHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"EXTENDED PHENYTOIN SODIUM","activeIngredients":"PHENYTOIN SODIUM","strength":"100MG EXTENDED","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-13
        )

)

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