ANDA 206167

TEVA PHARMS USA INC

FDA Drug Application

Application #206167

Application Sponsors

ANDA 206167

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

001	INJECTABLE;INJECTION	20MG/1ML	0	PRALATREXATE	PRALATREXATE
002	INJECTABLE;INJECTION	40MG/2ML	0	PRALATREXATE	PRALATREXATE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2016-01-21

STANDARD

Submissions Property Types

ORIG

1

Null

1

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
        )

)