INTL MEDICATION FDA Approval NDA 018025

NDA 018025

INTL MEDICATION

FDA Drug Application

Application #018025

Application Sponsors

NDA 018025INTL MEDICATION

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION10MG/ML0FUROSEMIDEFUROSEMIDE

FDA Submissions

ORIG1AP1979-01-10
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1985-05-08
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1985-06-13
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1987-05-01
LABELING; LabelingSUPPL22AP1991-03-15
LABELING; LabelingSUPPL23AP1992-04-29
LABELING; LabelingSUPPL24AP1992-03-17
LABELING; LabelingSUPPL25AP1992-03-17
MANUF (CMC); Manufacturing (CMC)SUPPL26AP1992-12-17
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1993-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL28AP1998-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL29AP1994-06-17
MANUF (CMC); Manufacturing (CMC)SUPPL30AP1994-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL31AP1995-09-19
LABELING; LabelingSUPPL32AP1998-03-05
LABELING; LabelingSUPPL33AP1999-09-17
MANUF (CMC); Manufacturing (CMC)SUPPL34AP2002-10-21

Submissions Property Types

SUPPL10Null0
SUPPL11Null0
SUPPL18Null0
SUPPL26Null0
SUPPL27Null0
SUPPL28Null0
SUPPL29Null0
SUPPL30Null0
SUPPL31Null0
SUPPL34Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18025
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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