XELLIA PHARMS APS FDA Approval ANDA 211757

ANDA 211757

XELLIA PHARMS APS

FDA Drug Application

Application #211757

Application Sponsors

ANDA 211757XELLIA PHARMS APS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION500MG/VIAL0CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE
002INJECTABLE;INJECTION1GM/VIAL0CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE
003INJECTABLE;INJECTION2GM/VIAL0CYCLOPHOSPHAMIDECYCLOPHOSPHAMIDE

FDA Submissions

UNKNOWN; ORIG1AP2022-10-18STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

XELLIA PHARMS APS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211757
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"1GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CYCLOPHOSPHAMIDE","activeIngredients":"CYCLOPHOSPHAMIDE","strength":"2GM\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-18
        )

)

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.