TEVA PHARMS USA INC FDA Approval ANDA 206167

ANDA 206167

TEVA PHARMS USA INC

FDA Drug Application

Application #206167

Application Sponsors

ANDA 206167TEVA PHARMS USA INC

Marketing Status

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

Application Products

001INJECTABLE;INJECTION20MG/1ML0PRALATREXATEPRALATREXATE
002INJECTABLE;INJECTION40MG/2ML0PRALATREXATEPRALATREXATE

FDA Submissions

UNKNOWN; ORIG1TA2016-01-21STANDARD

Submissions Property Types

ORIG1Null1

CDER Filings

TEVA PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206167
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRALATREXATE","activeIngredients":"PRALATREXATE","strength":"20MG\/1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PRALATREXATE","activeIngredients":"PRALATREXATE","strength":"40MG\/2ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/21\/2016","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-01-21
        )

)

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