HOSPIRA INC FDA Approval ANDA 202494

ANDA 202494

HOSPIRA INC

FDA Drug Application

Application #202494

Application Sponsors

ANDA 202494HOSPIRA INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION0.9MEQ/ML0SODIUM BICARBONATESODIUM BICARBONATE
002INJECTABLE;INJECTION1MEQ/ML0SODIUM BICARBONATESODIUM BICARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2017-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2021-06-14UNKNOWN

Submissions Property Types

ORIG1Null1
SUPPL9Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202494
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"0.9MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"1MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/06\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-06
        )

)

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