AMNEAL FDA Approval ANDA 212568

ANDA 212568

AMNEAL

FDA Drug Application

Application #212568

Application Sponsors

ANDA 212568AMNEAL

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL10MG0PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-27STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212568
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENOXYBENZAMINE HYDROCHLORIDE","activeIngredients":"PHENOXYBENZAMINE HYDROCHLORIDE","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/27\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-27
        )

)

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