ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P FDA Approval NDA 208419

NDA 208419

ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P

FDA Drug Application

Application #208419

Documents

Letter2020-08-24

Application Sponsors

NDA 208419ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION100MG/4ML0PEMETREXEDPEMETREXED
002INJECTABLE;INJECTION500MG/20ML0PEMETREXEDPEMETREXED
003INJECTABLE;INJECTION1G/40ML0PEMETREXEDPEMETREXED

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1AP2020-08-21STANDARD

Submissions Property Types

ORIG1Null40

CDER Filings

ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208419
            [companyName] => ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA P
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"100MG\/4ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"500MG\/20ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PEMETREXED","activeIngredients":"PEMETREXED","strength":"1G\/40ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208419Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-21
        )

)

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