ANDA 084486

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084486

Application Sponsors

ANDA 084486

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

750MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1975-05-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1983-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1983-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1985-10-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1984-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1986-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1986-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1987-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1987-03-25
LABELING; Labeling	SUPPL	44	AP	1989-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	49	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	50	AP	1998-12-01

Submissions Property Types

SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	45	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	49	Null	0
SUPPL	50	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84486
            [companyName] => SUN PHARM INDUSTRIES
            [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
        )

)