ANDA 075618

HIKMA INTL PHARMS

FDA Drug Application

Application #075618

Documents

• Letter: 2001-03-23

Application Sponsors

ANDA 075618

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

325MG;50MG;40MG;30MG

0

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

FDA Submissions

	ORIG	1	AP	2001-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2008-01-26
LABELING; Labeling	SUPPL	12	AP	2003-12-29
LABELING; Labeling	SUPPL	15	AP	2007-11-07
LABELING; Labeling	SUPPL	17	AP	2009-05-08
LABELING; Labeling	SUPPL	19	AP	2011-07-08
LABELING; Labeling	SUPPL	21	AP	2014-08-01	STANDARD
LABELING; Labeling	SUPPL	23	AP	2015-06-01	STANDARD
LABELING; Labeling	SUPPL	25	AP	2017-06-01	STANDARD
REMS; REMS	SUPPL	27	AP	2018-09-18

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	19	Null	7
SUPPL	21	Null	31
SUPPL	23	Null	7
SUPPL	25	Null	7
SUPPL	27	Null	7

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75618
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","strength":"325MG;50MG;40MG;30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE","actionType":"325MG;50MG;40MG;30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)