MYLAN FDA Approval ANDA 208120

ANDA 208120

MYLAN

FDA Drug Application

Application #208120

Application Sponsors

ANDA 208120MYLAN

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 100MG BASE/ML0VALPROATE SODIUMVALPROATE SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2021-12-22STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208120
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALPROATE SODIUM","activeIngredients":"VALPROATE SODIUM","strength":"EQ 100MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-22
        )

)

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