HOSPIRA INC FDA Approval NDA 214218

NDA 214218

HOSPIRA INC

FDA Drug Application

Application #214218

Documents

Letter2021-02-24

Application Sponsors

NDA 214218HOSPIRA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION100MG/4ML(25MG/ML)2PEMETREXEDPEMETREXED
002INJECTABLE;INJECTION500MG/20ML(25MG/ML)2PEMETREXEDPEMETREXED
003INJECTABLE;INJECTION1G/40ML(25MG/ML)2PEMETREXEDPEMETREXED

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1TA2021-02-23STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214218
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"100MG\/4ML(25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG\/20ML(25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"1G\/40ML(25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/23\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214218Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-23
        )

)

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