ANDA 084488

SUN PHARM INDUSTRIES

FDA Drug Application

Application #084488

Application Sponsors

ANDA 084488

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

METHOCARBAMOL

METHOCARBAMOL

FDA Submissions

	ORIG	1	AP	1975-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1983-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1985-11-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1984-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1985-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1986-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1987-12-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1987-04-06
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	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	38	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] => 84488
            [companyName] => SUN PHARM INDUSTRIES
            [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
        )

)