INTL MEDICATION FDA Approval ANDA 086402

ANDA 086402

INTL MEDICATION

FDA Drug Application

Application #086402

Application Sponsors

ANDA 086402INTL MEDICATION

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION0.01MG/ML;1%0LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1980-02-04
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-04-27
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1987-04-27
LABELING; LabelingSUPPL10AP1988-04-21
LABELING; LabelingSUPPL11AP1991-06-13
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1993-02-08
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1993-02-08
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1993-08-30
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1992-12-17
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1993-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1998-01-14
LABELING; LabelingSUPPL19AP1993-10-15
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1994-06-17
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1995-09-19

Submissions Property Types

SUPPL3Null0
SUPPL7Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL20Null0
SUPPL21Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86402
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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