FRESENIUS KABI USA FDA Approval ANDA 208317

ANDA 208317

FRESENIUS KABI USA

FDA Drug Application

Application #208317

Application Sponsors

ANDA 208317FRESENIUS KABI USA

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)0ICATIBANT ACETATEICATIBANT ACETATE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

FRESENIUS KABI USA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208317
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICATIBANT ACETATE","activeIngredients":"ICATIBANT ACETATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-18
        )

)

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