ANDA 208554

BAXTER HLTHCARE CORP

FDA Drug Application

Application #208554

Application Sponsors

ANDA 208554

BAXTER HLTHCARE CORP

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

2018-11-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

BAXTER HLTHCARE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208554
            [companyName] => BAXTER HLTHCARE CORP
            [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":"11\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-23
        )

)