ANDA 040109

MIKART

FDA Drug Application

Application #040109

Application Sponsors

ANDA 040109

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

356.4MG;30MG;16MG

0

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

FDA Submissions

	ORIG	1	AP	1997-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-07-31
LABELING; Labeling	SUPPL	3	AP	2000-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40109
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE","activeIngredients":"ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE","strength":"356.4MG;30MG;16MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE","submission":"ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE","actionType":"356.4MG;30MG;16MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)