ANDA 090543

HIKMA PHARMS

FDA Drug Application

Application #090543

Application Sponsors

ANDA 090543

HIKMA PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	100MG	0	MODAFINIL	MODAFINIL
002	TABLET;ORAL	200MG	0	MODAFINIL	MODAFINIL

FDA Submissions

ORIG

1

AP

2012-09-26

Submissions Property Types

ORIG

1

Null

7

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90543
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MODAFINIL","activeIngredients":"MODAFINIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MODAFINIL","activeIngredients":"MODAFINIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MODAFINIL","submission":"MODAFINIL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MODAFINIL","submission":"MODAFINIL","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)