LUPIN LTD FDA Approval ANDA 204131

ANDA 204131

LUPIN LTD

FDA Drug Application

Application #204131

Application Sponsors

ANDA 204131LUPIN LTD

Marketing Status

Prescription001

Application Products

001TABLET;ORAL200MG;300MG0EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-04

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204131
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE","activeIngredients":"EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","strength":"200MG;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/04\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-04
        )

)

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