HOSPIRA INC FDA Approval NDA 208746

NDA 208746

HOSPIRA INC

FDA Drug Application

Application #208746

Documents

Letter2021-01-12

Application Sponsors

NDA 208746HOSPIRA INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1TA2021-01-08STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208746
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/08\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/208746Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-08
        )

)

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