ANDA 203929

AKORN INC

FDA Drug Application

Application #203929

Application Sponsors

ANDA 203929

AKORN INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	4MCG/2ML (2MCG/ML)	0	DOXERCALCIFEROL	DOXERCALCIFEROL
002	INJECTABLE;INJECTION	2MCG/ML (2MCG/ML)	0	DOXERCALCIFEROL	DOXERCALCIFEROL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2015-05-07
LABELING; Labeling	SUPPL	4	AP	2016-10-13	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

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
        )

)