ANDA 085123

HIKMA INTL PHARMS

FDA Drug Application

Application #085123

Application Sponsors

ANDA 085123

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

750MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1976-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-05-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1986-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-04-09
LABELING; Labeling	SUPPL	15	AP	1989-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1987-02-04
LABELING; Labeling	SUPPL	18	AP	1989-05-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1990-11-21
LABELING; Labeling	SUPPL	23	AP	1992-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1995-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1995-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1995-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1996-02-22
LABELING; Labeling	SUPPL	28	AP	1996-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1995-11-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1999-03-11
LABELING; Labeling	SUPPL	34	AP	1999-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2000-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2002-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	2002-10-28
LABELING; Labeling	SUPPL	49	AP	2015-05-08	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	35	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	49	Null	7

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85123
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHOCARBAMOL","activeIngredients":"METHOCARBAMOL","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHOCARBAMOL","submission":"METHOCARBAMOL","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)