ANDA 204589

AKORN

FDA Drug Application

Application #204589

Application Sponsors

ANDA 204589

AKORN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	2MG/ML	0	EPTIFIBATIDE	EPTIFIBATIDE
002	INJECTABLE;INJECTION	75MG/100ML	0	EPTIFIBATIDE	EPTIFIBATIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-04-18

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204589
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPTIFIBATIDE","activeIngredients":"EPTIFIBATIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPTIFIBATIDE","activeIngredients":"EPTIFIBATIDE","strength":"75MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-18
        )

)