ZYDUS PHARMS FDA Approval ANDA 213527

ANDA 213527

ZYDUS PHARMS

FDA Drug Application

Application #213527

Application Sponsors

ANDA 213527ZYDUS PHARMS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 2MG BASE/ML0CISATRACURIUM BESYLATECISATRACURIUM BESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2020-09-01STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

ZYDUS PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213527
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-01
        )

)

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