PIRAMAL CRITICAL FDA Approval ANDA 215516

ANDA 215516

PIRAMAL CRITICAL

FDA Drug Application

Application #215516

Application Sponsors

ANDA 215516PIRAMAL CRITICAL

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-05-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

PIRAMAL CRITICAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215516
            [companyName] => PIRAMAL CRITICAL
            [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":"05\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-24
        )

)

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