ANDA 085159

HIKMA INTL PHARMS

FDA Drug Application

Application #085159

Application Sponsors

ANDA 085159

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1976-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-04-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1984-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1986-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1986-04-09
LABELING; Labeling	SUPPL	19	AP	1989-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-02-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1990-09-17
LABELING; Labeling	SUPPL	27	AP	1992-12-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1995-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1995-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-02-22
LABELING; Labeling	SUPPL	32	AP	1996-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1999-03-11
LABELING; Labeling	SUPPL	38	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2002-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2002-10-28
LABELING; Labeling	SUPPL	51	AP	2015-12-07	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	20	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	51	Null	7

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85159
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)