ANDA 080699

SUN PHARM INDUSTRIES

FDA Drug Application

Application #080699

Application Sponsors

ANDA 080699

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	200MG	0	MEPROBAMATE	MEPROBAMATE
002	TABLET;ORAL	400MG	0	MEPROBAMATE	MEPROBAMATE

FDA Submissions

	ORIG	1	AP	1972-10-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	118	AP	1986-03-12
LABELING; Labeling	SUPPL	121	AP	1988-10-13
LABELING; Labeling	SUPPL	122	AP	1989-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	123	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	124	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	125	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	126	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	128	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	129	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	130	AP	1998-12-01

Submissions Property Types

SUPPL	118	Null	0
SUPPL	123	Null	0
SUPPL	124	Null	0
SUPPL	125	Null	0
SUPPL	126	Null	0
SUPPL	128	Null	0
SUPPL	129	Null	0
SUPPL	130	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80699
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPROBAMATE","activeIngredients":"MEPROBAMATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MEPROBAMATE","activeIngredients":"MEPROBAMATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEPROBAMATE","submission":"MEPROBAMATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MEPROBAMATE","submission":"MEPROBAMATE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)