LUPIN LTD FDA Approval ANDA 205587

ANDA 205587

LUPIN LTD

FDA Drug Application

Application #205587

Application Sponsors

ANDA 205587LUPIN LTD

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL5MG0ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
002TABLET;ORAL10MG0ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
003TABLET;ORAL20MG0ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM
004TABLET;ORAL40MG0ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUM

FDA Submissions

UNKNOWN; ORIG1AP2017-07-31STANDARD
LABELING; LabelingSUPPL2AP2020-03-09STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205587
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROSUVASTATIN CALCIUM","activeIngredients":"ROSUVASTATIN CALCIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/09\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/09\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-09
        )

)

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