ANDA 077545

HIKMA INTL PHARMS

FDA Drug Application

Application #077545

Application Sponsors

ANDA 077545

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	EQ 4MG BASE	0	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE
002	TABLET;ORAL	EQ 8MG BASE	0	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE
003	TABLET;ORAL	EQ 24MG BASE	0	ONDANSETRON HYDROCHLORIDE	ONDANSETRON HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2007-09-06
LABELING; Labeling	SUPPL	2	AP	2008-04-11
LABELING; Labeling	SUPPL	3	AP	2013-02-27
LABELING; Labeling	SUPPL	4	AP	2013-02-27
LABELING; Labeling	SUPPL	7	AP	2013-02-27
LABELING; Labeling	SUPPL	8	AP	2015-01-15	STANDARD
LABELING; Labeling	SUPPL	11	AP	2018-02-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2018-02-21	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	7	Null	15
SUPPL	8	Null	15
SUPPL	11	Null	7
SUPPL	12	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77545
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 4MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 8MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ONDANSETRON HYDROCHLORIDE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 24MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 4MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 8MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ONDANSETRON HYDROCHLORIDE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 24MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)