ZYDUS PHARMS FDA Approval ANDA 216341

ANDA 216341

ZYDUS PHARMS

FDA Drug Application

Application #216341

Application Sponsors

ANDA 216341ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML0NOREPINEPHRINE BITARTRATENOREPINEPHRINE BITARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-07-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216341
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOREPINEPHRINE BITARTRATE","activeIngredients":"NOREPINEPHRINE BITARTRATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-19
        )

)

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