MARKSANS PHARMA FDA Approval ANDA 090295

ANDA 090295

MARKSANS PHARMA

FDA Drug Application

Application #090295

Application Sponsors

ANDA 090295MARKSANS PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL750MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

FDA Submissions

ORIG1AP2016-04-29
LABELING; LabelingSUPPL2AP2021-06-25STANDARD
LABELING; LabelingSUPPL3AP2021-06-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL3Null15

TE Codes

001PrescriptionAB1
002PrescriptionAB

CDER Filings

MARKSANS PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90295
            [companyName] => MARKSANS PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"750MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"500MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METFORMIN HYDROCHLORIDE","submission":"METFORMIN HYDROCHLORIDE","actionType":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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