HOSPIRA INC FDA Approval ANDA 090761

ANDA 090761

HOSPIRA INC

FDA Drug Application

Application #090761

Application Sponsors

ANDA 090761HOSPIRA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG/ML0ATRACURIUM BESYLATEATRACURIUM BESYLATE

FDA Submissions

ORIG1AP2012-10-18
LABELING; LabelingSUPPL2AP2018-07-26STANDARD

Submissions Property Types

ORIG1Null1
SUPPL2Null7

TE Codes

001PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90761
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATRACURIUM BESYLATE","activeIngredients":"ATRACURIUM BESYLATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATRACURIUM BESYLATE","submission":"ATRACURIUM BESYLATE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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