ANDA 200152

TEVA PHARMS USA INC

FDA Drug Application

Application #200152

Application Sponsors

ANDA 200152

TEVA PHARMS USA INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002
• None (Tentative Approval): 003
• None (Tentative Approval): 004
• None (Tentative Approval): 005

Application Products

001	TABLET;ORAL	50MG	0	ARMODAFINIL	ARMODAFINIL
002	TABLET;ORAL	100MG	0	ARMODAFINIL	ARMODAFINIL
003	TABLET;ORAL	150MG	0	ARMODAFINIL	ARMODAFINIL
004	TABLET;ORAL	200MG	0	ARMODAFINIL	ARMODAFINIL
005	TABLET;ORAL	250MG	0	ARMODAFINIL	ARMODAFINIL

FDA Submissions

ORIG

1

TA

2014-09-24

Submissions Property Types

ORIG

1

Null

19

CDER Filings

TEVA PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200152
            [companyName] => TEVA PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"ARMODAFINIL","activeIngredients":"ARMODAFINIL","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/24\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-09-24
        )

)