SAGENT PHARMS INC FDA Approval ANDA 091458

ANDA 091458

SAGENT PHARMS INC

FDA Drug Application

Application #091458

Application Sponsors

ANDA 091458SAGENT PHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION50MG/5ML (10MG/ML)0ROCURONIUM BROMIDEROCURONIUM BROMIDE
002INJECTABLE;INJECTION100MG/10ML (10MG/ML)0ROCURONIUM BROMIDEROCURONIUM BROMIDE

FDA Submissions

ORIG1AP2010-07-28
LABELING; LabelingSUPPL3AP2012-10-16STANDARD
LABELING; LabelingSUPPL4AP2015-10-16STANDARD
LABELING; LabelingSUPPL11AP2018-07-26STANDARD
LABELING; LabelingSUPPL13AP2020-06-25STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL4Null15
SUPPL11Null15
SUPPL13Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

SAGENT PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91458
            [companyName] => SAGENT PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"50MG\/5ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ROCURONIUM BROMIDE","activeIngredients":"ROCURONIUM BROMIDE","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ROCURONIUM BROMIDE","submission":"ROCURONIUM BROMIDE","actionType":"50MG\/5ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ROCURONIUM BROMIDE","submission":"ROCURONIUM BROMIDE","actionType":"100MG\/10ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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