ANDA 079032

AM REGENT

FDA Drug Application

Application #079032

Application Sponsors

ANDA 079032

AM REGENT

Marketing Status

• Discontinued: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	EQ 2MG BASE/ML	0	ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE	ONDANSETRON HYDROCHLORIDE
002	INJECTABLE; INJECTION	4MG/2ML	2	ONDANSETRON	ONDANSETRON

FDA Submissions

	ORIG	1	AP	2008-11-18
LABELING; Labeling	SUPPL	3	AP	2013-01-04	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-01-15	STANDARD

Submissions Property Types

SUPPL	3	Null	15
SUPPL	5	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79032
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONDANSETRON","activeIngredients":"ONDANSETRON","strength":"4MG\/2ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ONDANSETRON","submission":"ONDANSETRON","actionType":"4MG\/2ML","submissionClassification":"INJECTABLE; INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">TBD"},{"actionDate":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","submission":"ONDANSETRON HYDROCHLORIDE","actionType":"EQ 2MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)