APOTEX FDA Approval ANDA 210701

ANDA 210701

APOTEX

FDA Drug Application

Application #210701

Application Sponsors

ANDA 210701APOTEX

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL5MG0AMBRISENTANAMBRISENTAN
002TABLET;ORAL10MG0AMBRISENTANAMBRISENTAN

FDA Submissions

UNKNOWN; ORIG1AP2022-05-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

APOTEX
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210701
            [companyName] => APOTEX
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMBRISENTAN","activeIngredients":"AMBRISENTAN","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMBRISENTAN","submission":"AMBRISENTAN","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMBRISENTAN","submission":"AMBRISENTAN","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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