SAGENT PHARMS INC FDA Approval ANDA 078274

ANDA 078274

SAGENT PHARMS INC

FDA Drug Application

Application #078274

Application Sponsors

ANDA 078274SAGENT PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

ORIG1AP2008-12-29
LABELING; LabelingSUPPL4AP2018-07-26STANDARD

Submissions Property Types

SUPPL1Null7
SUPPL4Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78274
            [companyName] => SAGENT PHARMS INC
            [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":"VECURONIUM BROMIDE","submission":"VECURONIUM BROMIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"VECURONIUM BROMIDE","submission":"VECURONIUM BROMIDE","actionType":"20MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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