TARO FDA Approval ANDA 209430

ANDA 209430

TARO

FDA Drug Application

Application #209430

Application Sponsors

ANDA 209430TARO

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL25MG0DAPSONEDAPSONE
002TABLET;ORAL100MG0DAPSONEDAPSONE

FDA Submissions

UNKNOWN; ORIG1AP2019-03-01STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209430
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DAPSONE","activeIngredients":"DAPSONE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/01\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-03-01
        )

)

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