PRINSTON INC FDA Approval ANDA 078106

ANDA 078106

PRINSTON INC

FDA Drug Application

Application #078106

Application Sponsors

ANDA 078106PRINSTON INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL250MG0LEVETIRACETAMLEVETIRACETAM
002TABLET;ORAL500MG0LEVETIRACETAMLEVETIRACETAM
003TABLET;ORAL750MG0LEVETIRACETAMLEVETIRACETAM
004TABLET;ORAL1GM0LEVETIRACETAMLEVETIRACETAM

FDA Submissions

ORIG1AP2009-02-10
LABELING; LabelingSUPPL2AP2010-10-28
LABELING; LabelingSUPPL6AP2014-09-18STANDARD
LABELING; LabelingSUPPL9AP2014-09-18STANDARD
LABELING; LabelingSUPPL10AP2014-09-18STANDARD
LABELING; LabelingSUPPL11AP2015-10-19STANDARD
LABELING; LabelingSUPPL12AP2015-10-19STANDARD
LABELING; LabelingSUPPL14AP2023-01-05STANDARD
LABELING; LabelingSUPPL15AP2023-01-05STANDARD
LABELING; LabelingSUPPL16AP2023-01-05STANDARD
LABELING; LabelingSUPPL17AP2023-01-05STANDARD

Submissions Property Types

SUPPL6Null7
SUPPL9Null7
SUPPL10Null7
SUPPL11Null7
SUPPL12Null15
SUPPL14Null7
SUPPL15Null7
SUPPL16Null7
SUPPL17Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

PRINSTON INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78106
            [companyName] => PRINSTON INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM","activeIngredients":"LEVETIRACETAM","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVETIRACETAM","submission":"LEVETIRACETAM","actionType":"1GM","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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