PIRAMAL HLTHCARE UK FDA Approval ANDA 212432

ANDA 212432

PIRAMAL HLTHCARE UK

FDA Drug Application

Application #212432

Application Sponsors

ANDA 212432PIRAMAL HLTHCARE UK

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

UNKNOWN; ORIG1AP2022-03-11STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

PIRAMAL HLTHCARE UK
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212432
            [companyName] => PIRAMAL HLTHCARE UK
            [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":"CISATRACURIUM BESYLATE","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CISATRACURIUM BESYLATE","submission":"CISATRACURIUM BESYLATE","actionType":"EQ 10MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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