HARMAN FINOCHEM FDA Approval ANDA 213320

ANDA 213320

HARMAN FINOCHEM

FDA Drug Application

Application #213320

Application Sponsors

ANDA 213320HARMAN FINOCHEM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL500MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
002TABLET;ORAL850MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE
003TABLET;ORAL1GM0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-12-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HARMAN FINOCHEM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213320
            [companyName] => HARMAN FINOCHEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"850MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METFORMIN HYDROCHLORIDE","activeIngredients":"METFORMIN HYDROCHLORIDE","strength":"1GM","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/03\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-03
        )

)

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