HOSPIRA INC FDA Approval ANDA 202679

ANDA 202679

HOSPIRA INC

FDA Drug Application

Application #202679

Application Sponsors

ANDA 202679HOSPIRA INC

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION0.5MEQ/ML0SODIUM BICARBONATESODIUM BICARBONATE

FDA Submissions

UNKNOWN; ORIG1AP2017-03-07
LABELING; LabelingSUPPL2AP2017-08-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2021-06-14UNKNOWN

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL10Null7

TE Codes

001PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202679
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM BICARBONATE","activeIngredients":"SODIUM BICARBONATE","strength":"0.5MEQ\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/07\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/29\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-08-29
        )

)

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