ANDA 083567

HIKMA INTL PHARMS

FDA Drug Application

Application #083567

Application Sponsors

ANDA 083567

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

50MG

0

DIPHENHYDRAMINE HYDROCHLORIDE

DIPHENHYDRAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1973-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-08-22
LABELING; Labeling	SUPPL	17	AP	1989-05-01
BIOEQUIV; Bioequivalence	SUPPL	19	AP	1990-03-01

Submissions Property Types

SUPPL	12	Null	0
SUPPL	19	Null	0

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83567
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENHYDRAMINE HYDROCHLORIDE","activeIngredients":"DIPHENHYDRAMINE HYDROCHLORIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIPHENHYDRAMINE HYDROCHLORIDE","submission":"DIPHENHYDRAMINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)