ANDA 075820

ACTAVIS LABS FL INC

FDA Drug Application

Application #075820

Documents

• Letter: 2003-04-15

Application Sponsors

ANDA 075820

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

125MG

0

FLUTAMIDE

FLUTAMIDE

FDA Submissions

ORIG

1

AP

2001-09-18

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75820
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUTAMIDE","activeIngredients":"FLUTAMIDE","strength":"125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUTAMIDE","submission":"FLUTAMIDE","actionType":"125MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)