INTL MEDICATION SYS FDA Approval ANDA 087509

ANDA 087509

INTL MEDICATION SYS

FDA Drug Application

Application #087509

Application Sponsors

ANDA 087509INTL MEDICATION SYS

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION1%0MEPIVACAINE HYDROCHLORIDEMEPIVACAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1982-10-05
LABELING; LabelingSUPPL2AP1990-08-02
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1988-12-13
LABELING; LabelingSUPPL4AP1992-05-07
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-02-08
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1993-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1998-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1994-06-28
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1995-09-19

Submissions Property Types

SUPPL3Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0

CDER Filings

Accessdata Error
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87509
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.