PRINSTON INC FDA Approval ANDA 208782

ANDA 208782

PRINSTON INC

FDA Drug Application

Application #208782

Application Sponsors

ANDA 208782PRINSTON INC

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL0.5MG0ENTECAVIRENTECAVIR
002TABLET;ORAL1MG0ENTECAVIRENTECAVIR

FDA Submissions

UNKNOWN; ORIG1AP2017-10-10STANDARD
LABELING; LabelingSUPPL2AP2020-11-13STANDARD

Submissions Property Types

ORIG1Null31
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208782
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/10\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-10
        )

)

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