APOTEX FDA Approval ANDA 213356

ANDA 213356

APOTEX

FDA Drug Application

Application #213356

Application Sponsors

ANDA 213356APOTEX

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, EXTENDED RELEASE;ORAL500MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
002TABLET, EXTENDED RELEASE;ORAL1GM0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB3
002PrescriptionAB3

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213356
            [companyName] => APOTEX
            [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":"1GM","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":"1GM","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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