BAUSCH AND LOMB FDA Approval ANDA 040074

ANDA 040074

BAUSCH AND LOMB

FDA Drug Application

Application #040074

Application Sponsors

ANDA 040074BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.5%0PROPARACAINE HYDROCHLORIDEPROPARACAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1995-09-29
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-07-23
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-05-18
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-05-15
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-10-05
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-11-27

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40074
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"PROPARACAINE HYDROCHLORIDE","activeIngredients":"PROPARACAINE HYDROCHLORIDE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PROPARACAINE HYDROCHLORIDE","submission":"PROPARACAINE HYDROCHLORIDE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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