BAUSCH AND LOMB FDA Approval ANDA 064048

ANDA 064048

BAUSCH AND LOMB

FDA Drug Application

Application #064048

Application Sponsors

ANDA 064048BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMICEQ 0.3% BASE0GENTAMICIN SULFATEGENTAMICIN SULFATE

FDA Submissions

ORIG1AP1994-05-11
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-08-26
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-01-14
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-05-04
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-05-15
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-10-05
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-08-29
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-11-27

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64048
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENTAMICIN SULFATE","activeIngredients":"GENTAMICIN SULFATE","strength":"EQ 0.3% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENTAMICIN SULFATE","submission":"GENTAMICIN SULFATE","actionType":"EQ 0.3% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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