ANDA 040124

HIKMA INTL PHARMS

FDA Drug Application

Application #040124

Documents

• Letter: 2008-01-09

Application Sponsors

ANDA 040124

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

350MG

0

CARISOPRODOL

CARISOPRODOL

FDA Submissions

	ORIG	1	AP	1996-01-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-12-04
LABELING; Labeling	SUPPL	8	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-10-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-06-12
LABELING; Labeling	SUPPL	14	AP	2007-12-31
LABELING; Labeling	SUPPL	16	AP	2010-08-02
LABELING; Labeling	SUPPL	18	AP	2011-05-27
LABELING; Labeling	SUPPL	20	AP	2015-06-09	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	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	20	Null	7

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40124
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARISOPRODOL","activeIngredients":"CARISOPRODOL","strength":"350MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARISOPRODOL","submission":"CARISOPRODOL","actionType":"350MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)