BAUSCH AND LOMB FDA Approval ANDA 064135

ANDA 064135

BAUSCH AND LOMB

FDA Drug Application

Application #064135

Application Sponsors

ANDA 064135BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001SUSPENSION/DROPS;OPHTHALMIC0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML0DEXASPORINDEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

ORIG1AP1995-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-08-19
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-02-11
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-11-19
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-07-02
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-05-02
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-08-21
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-11-27
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2002-02-05
LABELING; LabelingSUPPL34AP2020-02-07STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL34Null15

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64135
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXASPORIN","activeIngredients":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"0.1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXASPORIN","submission":"DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"0.1%;EQ 3.5MG BASE\/ML;10,000 UNITS\/ML","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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