BAXTER HLTHCARE CORP FDA Approval ANDA 208554

ANDA 208554

BAXTER HLTHCARE CORP

FDA Drug Application

Application #208554

Application Sponsors

ANDA 208554BAXTER HLTHCARE CORP

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION2MG/ML0EPTIFIBATIDEEPTIFIBATIDE
002INJECTABLE;INJECTION75MG/100ML0EPTIFIBATIDEEPTIFIBATIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-11-23STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

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
        )

)

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