BAUSCH AND LOMB FDA Approval ANDA 074307

ANDA 074307

BAUSCH AND LOMB

FDA Drug Application

Application #074307

Application Sponsors

ANDA 074307BAUSCH AND LOMB

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.25%0LEVOBUNOLOL HYDROCHLORIDELEVOBUNOLOL HYDROCHLORIDE

FDA Submissions

ORIG1AP1994-03-04
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1995-11-20
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1995-11-20
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1996-05-30
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1996-05-28
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1998-03-11
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1998-01-28
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1998-09-08
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-05-15
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2000-10-05
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2001-11-27
LABELING; LabelingSUPPL19AP2002-12-19

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74307
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOBUNOLOL HYDROCHLORIDE","activeIngredients":"LEVOBUNOLOL HYDROCHLORIDE","strength":"0.25%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOBUNOLOL HYDROCHLORIDE","submission":"LEVOBUNOLOL HYDROCHLORIDE","actionType":"0.25%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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