ALKEM LABS LTD FDA Approval ANDA 211856

ANDA 211856

ALKEM LABS LTD

FDA Drug Application

Application #211856

Application Sponsors

ANDA 211856ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;ORALEQ 4GM RESIN/PACKET0CHOLESTYRAMINECHOLESTYRAMINE
002POWDER;ORALEQ 4GM RESIN/SCOOPFUL0CHOLESTYRAMINECHOLESTYRAMINE

FDA Submissions

UNKNOWN; ORIG1AP2021-10-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211856
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHOLESTYRAMINE","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/PACKET","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CHOLESTYRAMINE","activeIngredients":"CHOLESTYRAMINE","strength":"EQ 4GM RESIN\/SCOOPFUL","dosageForm":"POWDER;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-19
        )

)

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