BAUSCH AND LOMB FDA Approval ANDA 074443

ANDA 074443

BAUSCH AND LOMB

FDA Drug Application

Application #074443

Application Sponsors

ANDA 074443BAUSCH AND LOMB

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC4%0CROLOMCROMOLYN SODIUM

FDA Submissions

ORIG1AP1995-01-30
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-03-06
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-03-25
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1997-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-07-27
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-03-26
LABELING; LabelingSUPPL8AP1999-06-16
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-11-01
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1999-12-27
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-04-30
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2002-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2001-11-27
LABELING; LabelingSUPPL20AP2002-12-09

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL19Null0

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74443
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"CROLOM","activeIngredients":"CROMOLYN SODIUM","strength":"4%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CROLOM","submission":"CROMOLYN SODIUM","actionType":"4%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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