ANDA 087407

SUN PHARM INDUSTRIES

FDA Drug Application

Application #087407

Application Sponsors

ANDA 087407

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;SUBLINGUAL

0.5MG

0

ERGOLOID MESYLATES

ERGOLOID MESYLATES

FDA Submissions

	ORIG	1	AP	1981-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1984-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1987-03-31
LABELING; Labeling	SUPPL	13	AP	1989-04-10
LABELING; Labeling	SUPPL	14	AP	1988-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-12-01

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87407
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERGOLOID MESYLATES","activeIngredients":"ERGOLOID MESYLATES","strength":"0.5MG","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERGOLOID MESYLATES","submission":"ERGOLOID MESYLATES","actionType":"0.5MG","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)