VISTAPHARM FDA Approval ANDA 204166

ANDA 204166

VISTAPHARM

FDA Drug Application

Application #204166

Application Sponsors

ANDA 204166VISTAPHARM

Marketing Status

Prescription001

Application Products

001TABLET;ORAL10MG0METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-03-16STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAA

CDER Filings

VISTAPHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204166
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHADONE HYDROCHLORIDE","activeIngredients":"METHADONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/16\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-03-16
        )

)

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