NEXUS PHARMS FDA Approval ANDA 213532

ANDA 213532

NEXUS PHARMS

FDA Drug Application

Application #213532

Application Sponsors

ANDA 213532NEXUS PHARMS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INTRAVENOUS500MG/100ML (5MG/ML)0LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM
002INJECTABLE;INTRAVENOUS1000MG/100ML (10MG/ML)0LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM
003INJECTABLE;INTRAVENOUS1500MG/100ML (15MG/ML)0LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAM

FDA Submissions

UNKNOWN; ORIG1AP2020-07-06STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

NEXUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213532
            [companyName] => NEXUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"500MG\/100ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"1000MG\/100ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVETIRACETAM IN SODIUM CHLORIDE","activeIngredients":"LEVETIRACETAM","strength":"1500MG\/100ML (15MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-06
        )

)

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