TAGI FDA Approval ANDA 209599

ANDA 209599

TAGI

FDA Drug Application

Application #209599

Application Sponsors

ANDA 209599TAGI

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;ORALEQ 4GM RESIN/PACKET0CHOLESTYRAMINE LIGHTCHOLESTYRAMINE
002POWDER;ORALEQ 4GM RESIN/SCOOPFUL0CHOLESTYRAMINE LIGHTCHOLESTYRAMINE

FDA Submissions

UNKNOWN; ORIG1AP2020-11-12STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

TAGI
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209599
            [companyName] => TAGI
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHOLESTYRAMINE LIGHT","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHOLESTYRAMINE LIGHT","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/SCOOPFUL","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/12\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-12
        )

)

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