AM REGENT FDA Approval ANDA 079032

ANDA 079032

AM REGENT

FDA Drug Application

Application #079032

Application Sponsors

ANDA 079032AM REGENT

Marketing Status

Discontinued001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 2MG BASE/ML0ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREEONDANSETRON HYDROCHLORIDE
002INJECTABLE; INJECTION4MG/2ML2ONDANSETRONONDANSETRON

FDA Submissions

ORIG1AP2008-11-18
LABELING; LabelingSUPPL3AP2013-01-04STANDARD
LABELING; LabelingSUPPL5AP2015-01-15STANDARD

Submissions Property Types

SUPPL3Null15
SUPPL5Null7

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
        )

)

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