AKORN INC FDA Approval ANDA 203929

ANDA 203929

AKORN INC

FDA Drug Application

Application #203929

Application Sponsors

ANDA 203929AKORN INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION4MCG/2ML (2MCG/ML)0DOXERCALCIFEROLDOXERCALCIFEROL
002INJECTABLE;INJECTION2MCG/ML (2MCG/ML)0DOXERCALCIFEROLDOXERCALCIFEROL

FDA Submissions

UNKNOWN; ORIG1AP2015-05-07
LABELING; LabelingSUPPL4AP2016-10-13STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

AKORN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203929
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"4MCG\/2ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOXERCALCIFEROL","activeIngredients":"DOXERCALCIFEROL","strength":"2MCG\/ML (2MCG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/13\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-10-13
        )

)

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