ANDA 040085

MIKART

FDA Drug Application

Application #040085

Application Sponsors

ANDA 040085

MIKART

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

500MG;50MG;40MG

0

ESGIC-PLUS

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	1996-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-04-20
LABELING; Labeling	SUPPL	8	AP	2000-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1998-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-08-13

Submissions Property Types

ORIG	1	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

MIKART

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40085
            [companyName] => MIKART
            [docInserts] => ["",""]
            [products] => [{"drugName":"ESGIC-PLUS","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"500MG;50MG;40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ESGIC-PLUS","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"500MG;50MG;40MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)