ABBOTT FDA Approval NDA 019185

NDA 019185

ABBOTT

FDA Drug Application

Application #019185

Application Sponsors

NDA 019185ABBOTT

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004

Application Products

001INJECTABLE;INJECTION1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1OXYTOCIN 5 USP UNITS IN DEXTROSE 5%OXYTOCIN
002INJECTABLE;INJECTION2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1OXYTOCIN 20 USP UNITS IN DEXTROSE 5%OXYTOCIN
003INJECTABLE;INJECTION2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1OXYTOCIN 10 USP UNITS IN DEXTROSE 5%OXYTOCIN
004INJECTABLE;INJECTION1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1OXYTOCIN 10 USP UNITS IN DEXTROSE 5%OXYTOCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1985-03-29STANDARD
LABELING; LabelingSUPPL4AP1986-11-13

CDER Filings

ABBOTT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19185
            [companyName] => ABBOTT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYTOCIN 20 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"OXYTOCIN 5 USP UNITS IN DEXTROSE 5%","activeIngredients":"OXYTOCIN","strength":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OXYTOCIN 10 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OXYTOCIN 20 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"2USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"OXYTOCIN 5 USP UNITS IN DEXTROSE 5%","submission":"OXYTOCIN","actionType":"1USP UNITS\/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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