INTL MEDICATION FDA Approval ANDA 083724

ANDA 083724

INTL MEDICATION

FDA Drug Application

Application #083724

Application Sponsors

ANDA 083724INTL MEDICATION

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION0.2MG/ML0ISOPROTERENOL HYDROCHLORIDEISOPROTERENOL HYDROCHLORIDE

FDA Submissions

ORIG1AP1976-01-06
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-04-23
LABELING; LabelingSUPPL10AP1991-12-27
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1993-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1994-06-17
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-09-19
LABELING; LabelingSUPPL14AP1996-09-27
LABELING; LabelingSUPPL15AP1998-07-16

Submissions Property Types

SUPPL3Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83724
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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