KARTHA FDA Approval ANDA 214663

ANDA 214663

KARTHA

FDA Drug Application

Application #214663

Application Sponsors

ANDA 214663KARTHA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL25MG0EPLERENONEEPLERENONE
002TABLET;ORAL50MG0EPLERENONEEPLERENONE

FDA Submissions

UNKNOWN; ORIG1AP2022-03-23STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

KARTHA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214663
            [companyName] => KARTHA
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPLERENONE","activeIngredients":"EPLERENONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPLERENONE","activeIngredients":"EPLERENONE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-23
        )

)

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