NEXUS PHARMS FDA Approval ANDA 209780

ANDA 209780

NEXUS PHARMS

FDA Drug Application

Application #209780

Application Sponsors

ANDA 209780NEXUS PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/ML0ARSENIC TRIOXIDEARSENIC TRIOXIDE

FDA Submissions

UNKNOWN; ORIG1AP2018-11-15STANDARD
LABELING; LabelingSUPPL3AP2022-10-27STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null7

TE Codes

001PrescriptionAP

CDER Filings

NEXUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209780
            [companyName] => NEXUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARSENIC TRIOXIDE","activeIngredients":"ARSENIC TRIOXIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/15\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-15
        )

)

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