NOVARTIS FDA Approval ANDA 062501

ANDA 062501

NOVARTIS

FDA Drug Application

Application #062501

Application Sponsors

ANDA 062501NOVARTIS

Marketing Status

Discontinued001

Application Products

001OINTMENT;OPHTHALMICEQ 0.3% BASE0GENTACIDINGENTAMICIN SULFATE

FDA Submissions

ORIG1AP1984-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-12-09
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1995-12-15
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1996-07-03
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1996-07-03

Submissions Property Types

ORIG1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62501
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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