ANDA 076715

WATSON LABS INC

FDA Drug Application

Application #076715

Application Sponsors

ANDA 076715

WATSON LABS INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

ORIG

1

AP

2012-11-01

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

WATSON LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76715
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MODAFINIL","activeIngredients":"MODAFINIL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MODAFINIL","activeIngredients":"MODAFINIL","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MODAFINIL","submission":"MODAFINIL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MODAFINIL","submission":"MODAFINIL","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)