ANDA 087765

HIKMA PHARMS

FDA Drug Application

Application #087765

Application Sponsors

ANDA 087765

HIKMA PHARMS

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	1982-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1984-10-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-03-28

Submissions Property Types

SUPPL	3	Null	0
SUPPL	9	Null	0

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87765
            [companyName] => HIKMA
            [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
        )

)