CADILA FDA Approval ANDA 077078

ANDA 077078

CADILA

FDA Drug Application

Application #077078

Application Sponsors

ANDA 077078CADILA

Marketing Status

Prescription001

Application Products

001TABLET, EXTENDED RELEASE;ORAL750MG0METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE

FDA Submissions

ORIG1AP2005-04-21
LABELING; LabelingSUPPL2AP2008-01-28
LABELING; LabelingSUPPL3AP2008-10-31

TE Codes

001PrescriptionAB

CDER Filings

CADILA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77078
            [companyName] => CADILA
            [docInserts] => ["",""]
            [products] => [{"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":"750MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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