GLAND PHARMA LTD FDA Approval ANDA 205390

ANDA 205390

GLAND PHARMA LTD

FDA Drug Application

Application #205390

Application Sponsors

ANDA 205390GLAND PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION10MG/VIAL0VECURONIUM BROMIDEVECURONIUM BROMIDE
002INJECTABLE;INJECTION20MG/VIAL0VECURONIUM BROMIDEVECURONIUM BROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2016-05-26STANDARD
LABELING; LabelingSUPPL2AP2018-07-26STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205390
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VECURONIUM BROMIDE","activeIngredients":"VECURONIUM BROMIDE","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/26\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-07-26
        )

)

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