ALCON FDA Approval ANDA 080229

ANDA 080229

ALCON

FDA Drug Application

Application #080229

Application Sponsors

ANDA 080229ALCON

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.1%0NAPHCON FORTENAPHAZOLINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1974-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1982-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1982-11-26
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1987-08-06
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1989-04-27
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1993-06-04
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1993-06-04
LABELING; LabelingSUPPL16AP1993-04-06
LABELING; LabelingSUPPL17AP1996-07-02
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1995-08-04
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1995-10-05
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1996-01-25
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1996-04-01
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1999-03-04
MANUF (CMC); Manufacturing (CMC)SUPPL23AP1999-05-07
MANUF (CMC); Manufacturing (CMC)SUPPL24AP1999-03-23
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2000-04-28

Submissions Property Types

SUPPL5Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0
SUPPL25Null0

CDER Filings

ALCON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80229
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAPHCON FORTE","activeIngredients":"NAPHAZOLINE HYDROCHLORIDE","strength":"0.1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAPHCON FORTE","submission":"NAPHAZOLINE HYDROCHLORIDE","actionType":"0.1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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