BAUSCH AND LOMB FDA Approval ANDA 064068

ANDA 064068

BAUSCH AND LOMB

FDA Drug Application

Application #064068

Application Sponsors

ANDA 064068BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001OINTMENT;OPHTHALMIC400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM0NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONEBACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

FDA Submissions

ORIG1AP1995-10-30
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1997-09-03
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-10-22
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-05-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-03-30
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-11-23
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-03-05
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2000-08-24
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-04-21
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-11-27
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2002-02-05
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2002-07-18
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2002-08-06
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-07-18

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64068
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE","activeIngredients":"BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","strength":"400 UNITS\/GM;1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE","submission":"BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE","actionType":"400 UNITS\/GM;1%;EQ 3.5MG BASE\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.