HOSPIRA INC FDA Approval ANDA 204118

ANDA 204118

HOSPIRA INC

FDA Drug Application

Application #204118

Application Sponsors

ANDA 204118HOSPIRA INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/VIAL0INDOMETHACIN SODIUMINDOMETHACIN SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2016-04-19

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204118
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"INDOMETHACIN SODIUM","activeIngredients":"INDOMETHACIN SODIUM","strength":"EQ 1MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/19\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-04-19
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.