SANDOZ INC FDA Approval ANDA 205744

ANDA 205744

SANDOZ INC

FDA Drug Application

Application #205744

Documents

Letter2021-06-15

Application Sponsors

ANDA 205744SANDOZ INC

Marketing Status

None (Tentative Approval)001

Application Products

001UNKNOWNUNKNOWN0DRONEDARONE HYDROCHLORIDEDRONEDARONE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2021-05-17STANDARD

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205744
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRONEDARONE HYDROCHLORIDE","activeIngredients":"DRONEDARONE HYDROCHLORIDE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/17\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-17
        )

)

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