INTL MEDICATION FDA Approval NDA 018014

NDA 018014

INTL MEDICATION

FDA Drug Application

Application #018014

Application Sponsors

NDA 018014INTL MEDICATION

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION40MG/ML0DOPAMINE HYDROCHLORIDEDOPAMINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1981-05-19
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1986-05-20
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1991-02-21
LABELING; LabelingSUPPL17AP1991-06-12
LABELING; LabelingSUPPL18AP1991-10-23
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1992-08-11
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1992-12-17
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1993-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1998-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1994-06-17
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1995-09-19

Submissions Property Types

SUPPL10Null0
SUPPL12Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18014
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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