ANDA 040316

MIKART

FDA Drug Application

Application #040316

Documents

• Letter: 1999-04-28

Application Sponsors

ANDA 040316

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

712.8MG;60MG;32MG

0

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

FDA Submissions

	ORIG	1	AP	1999-04-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	4	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40316
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE","activeIngredients":"ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE","strength":"712.8MG;60MG;32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE","submission":"ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE","actionType":"712.8MG;60MG;32MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)