ANDA 089718

HIKMA PHARMS

FDA Drug Application

Application #089718

Application Sponsors

ANDA 089718

HIKMA PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

325MG;50MG;40MG

0

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

FDA Submissions

	ORIG	1	AP	1995-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-05-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-03-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-08-23
LABELING; Labeling	SUPPL	8	AP	2003-06-03
LABELING; Labeling	SUPPL	12	AP	2011-06-23
LABELING; Labeling	SUPPL	15	AP	2013-10-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-06-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	12	Null	7
SUPPL	15	Null	15
SUPPL	17	Null	7

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89718
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;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":"325MG;50MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)