NEXUS PHARMS FDA Approval ANDA 206332

ANDA 206332

NEXUS PHARMS

FDA Drug Application

Application #206332

Application Sponsors

ANDA 206332NEXUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION100MG/ML0PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE
002INJECTABLE;INJECTION500MG/ML0PROCAINAMIDE HYDROCHLORIDEPROCAINAMIDE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-10-13STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

NEXUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206332
            [companyName] => NEXUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PROCAINAMIDE HYDROCHLORIDE","activeIngredients":"PROCAINAMIDE HYDROCHLORIDE","strength":"500MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-13
        )

)

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