INTL MEDICATION FDA Approval ANDA 070119

ANDA 070119

INTL MEDICATION

FDA Drug Application

Application #070119

Application Sponsors

ANDA 070119INTL MEDICATION

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION50MG/ML0BRETYLIUM TOSYLATEBRETYLIUM TOSYLATE

FDA Submissions

ORIG1AP1986-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1991-04-19
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1991-04-19
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1992-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1992-07-31
LABELING; LabelingSUPPL9AP1992-02-18
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1993-10-29
LABELING; LabelingSUPPL13AP1993-09-30
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1998-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1994-06-17
LABELING; LabelingSUPPL16AP1994-11-08
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1995-09-19

Submissions Property Types

SUPPL1Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL12Null0
SUPPL14Null0
SUPPL15Null0
SUPPL17Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70119
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.