PRINSTON INC FDA Approval ANDA 077370

ANDA 077370

PRINSTON INC

FDA Drug Application

Application #077370

Application Sponsors

ANDA 077370PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL1MG0GLIMEPIRIDEGLIMEPIRIDE
002TABLET;ORAL2MG0GLIMEPIRIDEGLIMEPIRIDE
003TABLET;ORAL4MG0GLIMEPIRIDEGLIMEPIRIDE
004TABLET;ORAL8MG0GLIMEPIRIDEGLIMEPIRIDE

FDA Submissions

ORIG1AP2005-12-23
LABELING; LabelingSUPPL2AP2008-04-28
LABELING; LabelingSUPPL4AP2012-05-31
LABELING; LabelingSUPPL9AP2015-10-27STANDARD
LABELING; LabelingSUPPL10AP2015-10-27STANDARD

Submissions Property Types

SUPPL4Null15
SUPPL9Null15
SUPPL10Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77370
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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