MANKIND PHARMA FDA Approval ANDA 214282

ANDA 214282

MANKIND PHARMA

FDA Drug Application

Application #214282

Application Sponsors

ANDA 214282MANKIND PHARMA

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL125MG0ACETAZOLAMIDEACETAZOLAMIDE
002TABLET;ORAL250MG0ACETAZOLAMIDEACETAZOLAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-07STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

MANKIND PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214282
            [companyName] => MANKIND PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ACETAZOLAMIDE","activeIngredients":"ACETAZOLAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/07\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-07
        )

)

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