ABBVIE FDA Approval NDA 020200

NDA 020200

ABBVIE

FDA Drug Application

Application #020200

Application Sponsors

NDA 020200ABBVIE

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1.5MG/ML0NALBUPHINE HYDROCHLORIDENALBUPHINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1993-03-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-10-31STANDARD

Submissions Property Types

SUPPL3Null0

CDER Filings

ABBVIE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20200
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NALBUPHINE HYDROCHLORIDE","activeIngredients":"NALBUPHINE HYDROCHLORIDE","strength":"1.5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NALBUPHINE HYDROCHLORIDE","submission":"NALBUPHINE HYDROCHLORIDE","actionType":"1.5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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