ZYDUS PHARMS FDA Approval ANDA 212171

ANDA 212171

ZYDUS PHARMS

FDA Drug Application

Application #212171

Application Sponsors

ANDA 212171ZYDUS PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 2MG BASE/ML0CISATRACURIUM BESYLATECISATRACURIUM BESYLATE
002INJECTABLE;INJECTIONEQ 10MG BASE/ML0CISATRACURIUM BESYLATECISATRACURIUM BESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2019-11-04STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212171
            [companyName] => ZYDUS PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CISATRACURIUM BESYLATE","activeIngredients":"CISATRACURIUM BESYLATE","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/04\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-11-04
        )

)

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