ANDA 040496

MIKART

FDA Drug Application

Application #040496

Application Sponsors

ANDA 040496

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

750MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

ORIG

1

AP

2003-12-23

Submissions Property Types

ORIG

1

Null

0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40496
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"750MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"750MG;50MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)