ANDA 077699

HIKMA INTL PHARMS

FDA Drug Application

Application #077699

Application Sponsors

ANDA 077699

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

250MG

0

MEFLOQUINE HYDROCHLORIDE

MEFLOQUINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-04-21
LABELING; Labeling	SUPPL	5	AP	2016-10-11	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-10-06	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	5	Null	15
SUPPL	6	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77699
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEFLOQUINE HYDROCHLORIDE","activeIngredients":"MEFLOQUINE HYDROCHLORIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MEFLOQUINE HYDROCHLORIDE","submission":"MEFLOQUINE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)