BAUSCH AND LOMB FDA Approval ANDA 064063

ANDA 064063

BAUSCH AND LOMB

FDA Drug Application

Application #064063

Application Sponsors

ANDA 064063BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001OINTMENT;OPHTHALMIC0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM0NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

ORIG1AP1994-07-25
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-10-04
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1997-07-23
LABELING; LabelingSUPPL4AP1997-07-23
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1997-07-23
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-10-22
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1998-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1999-03-30
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1998-11-16
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-02-11
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2000-08-21
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-11-27
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2002-02-05
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-08-21
MANUF (CMC); Manufacturing (CMC)SUPPL19AP2002-08-27
MANUF (CMC); Manufacturing (CMC)SUPPL20AP2002-08-27
LABELING; LabelingSUPPL41AP2020-02-07STANDARD
LABELING; LabelingSUPPL42AP2020-02-07STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL41Null7
SUPPL42Null15

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64063
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE","activeIngredients":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"0.1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE","submission":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"0.1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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