ANDA 085506

SUN PHARM INDUSTRIES

FDA Drug Application

Application #085506

Application Sponsors

ANDA 085506

SUN PHARM INDUSTRIES

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.025MG;2.5MG

0

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1977-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1983-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1987-04-10
LABELING; Labeling	SUPPL	59	AP	1991-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1992-04-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	1992-04-03
LABELING; Labeling	SUPPL	63	AP	1993-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	1994-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	65	AP	1998-12-01

Submissions Property Types

SUPPL	38	Null	0
SUPPL	47	Null	0
SUPPL	60	Null	0
SUPPL	62	Null	0
SUPPL	64	Null	0
SUPPL	65	Null	0

CDER Filings

SUN PHARM INDUSTRIES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85506
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","strength":"0.025MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","submission":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","actionType":"0.025MG;2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)