ALCON FDA Approval ANDA 062628

ANDA 062628

ALCON

FDA Drug Application

Application #062628

Application Sponsors

ANDA 062628ALCON

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.5%0CHLORAMPHENICOLCHLORAMPHENICOL

FDA Submissions

ORIG1AP1985-09-25
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1988-11-16
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1988-11-30
LABELING; LabelingSUPPL8AP1992-01-09
LABELING; LabelingSUPPL9AP1993-02-19
LABELING; LabelingSUPPL10AP1993-11-17
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1995-05-19
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1996-04-16
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1995-07-19
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1999-02-02
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1999-02-19

Submissions Property Types

SUPPL6Null0
SUPPL7Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL16Null0

CDER Filings

ALCON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62628
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORAMPHENICOL","activeIngredients":"CHLORAMPHENICOL","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORAMPHENICOL","submission":"CHLORAMPHENICOL","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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