BIOCON LTD FDA Approval ANDA 208927

ANDA 208927

BIOCON LTD

FDA Drug Application

Application #208927

Application Sponsors

ANDA 208927BIOCON LTD

Marketing Status

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

Application Products

001INJECTABLE;INJECTION100MG0PEMETREXEDPEMETREXED
002INJECTABLE;INJECTION500MG0PEMETREXEDPEMETREXED

FDA Submissions

UNKNOWN; ORIG1TA2018-05-04STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

BIOCON LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208927
            [companyName] => BIOCON LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-04
        )

)

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