BAUSCH AND LOMB FDA Approval ANDA 075546

ANDA 075546

BAUSCH AND LOMB

FDA Drug Application

Application #075546

Documents

Letter2000-01-20

Application Sponsors

ANDA 075546BAUSCH AND LOMB

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC1%0CARTEOLOL HYDROCHLORIDECARTEOLOL HYDROCHLORIDE

FDA Submissions

ORIG1AP2000-01-20
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-08-21
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-09-21
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-10-05
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2001-11-27

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75546
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARTEOLOL HYDROCHLORIDE","activeIngredients":"CARTEOLOL HYDROCHLORIDE","strength":"1%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARTEOLOL HYDROCHLORIDE","submission":"CARTEOLOL HYDROCHLORIDE","actionType":"1%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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