HUMANWELL PURACAP FDA Approval ANDA 214580

ANDA 214580

HUMANWELL PURACAP

FDA Drug Application

Application #214580

Application Sponsors

ANDA 214580HUMANWELL PURACAP

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG0AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-12-20STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

HUMANWELL PURACAP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214580
            [companyName] => HUMANWELL PURACAP
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMANTADINE HYDROCHLORIDE","activeIngredients":"AMANTADINE HYDROCHLORIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMANTADINE HYDROCHLORIDE","submission":"AMANTADINE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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