ANDA 080700

SUN PHARM INDUSTRIES

FDA Drug Application

Application #080700

Application Sponsors

ANDA 080700

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

4MG

0

CHLORPHENIRAMINE MALEATE

CHLORPHENIRAMINE MALEATE

FDA Submissions

	ORIG	1	AP	1972-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1987-04-09
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	44	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] => 80700
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPHENIRAMINE MALEATE","activeIngredients":"CHLORPHENIRAMINE MALEATE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPHENIRAMINE MALEATE","submission":"CHLORPHENIRAMINE MALEATE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)