ANDA 040387

MIKART

FDA Drug Application

Application #040387

Application Sponsors

ANDA 040387

MIKART

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

325MG/15ML;50MG/15ML;40MG/15ML

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	2003-01-31
LABELING; Labeling	SUPPL	10	AP	2009-07-06
LABELING; Labeling	SUPPL	12	AP	2011-06-22
LABELING; Labeling	SUPPL	13	AP	2013-10-18	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	13	Null	15

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40387
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG\/15ML;50MG\/15ML;40MG\/15ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"325MG\/15ML;50MG\/15ML;40MG\/15ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)