PRINSTON INC FDA Approval ANDA 203071

ANDA 203071

PRINSTON INC

FDA Drug Application

Application #203071

Application Sponsors

ANDA 203071PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL75MG0IRBESARTANIRBESARTAN
002TABLET;ORAL150MG0IRBESARTANIRBESARTAN
003TABLET;ORAL300MG0IRBESARTANIRBESARTAN

FDA Submissions

UNKNOWN; ORIG1AP2012-09-27
LABELING; LabelingSUPPL3AP2016-08-22STANDARD
LABELING; LabelingSUPPL5AP2020-08-13STANDARD
LABELING; LabelingSUPPL7AP2021-09-15STANDARD
LABELING; LabelingSUPPL8AP2021-09-15STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL5Null15
SUPPL7Null7
SUPPL8Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203071
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/13\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/22\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/17\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-08-13
        )

)

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