HOSPIRA INC FDA Approval ANDA 202111

ANDA 202111

HOSPIRA INC

FDA Drug Application

Application #202111

Application Sponsors

ANDA 202111HOSPIRA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
Prescription003

Application Products

001INJECTABLE;INJECTION100MG0PEMETREXED DISODIUMPEMETREXED DISODIUM
002INJECTABLE;INJECTION500MG0PEMETREXED DISODIUMPEMETREXED DISODIUM
003POWDER;INTRAVENOUSEQ 1GM BASE/VIAL0PEMETREXED DISODIUMPEMETREXED DISODIUM

FDA Submissions

N/A; Not ApplicableORIG1TA2015-07-31

Submissions Property Types

ORIG1Null19

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202111
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED DISODIUM","activeIngredients":"PEMETREXED DISODIUM","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/31\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-07-31
        )

)

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