BAUSCH AND LOMB FDA Approval ANDA 064046

ANDA 064046

BAUSCH AND LOMB

FDA Drug Application

Application #064046

Application Sponsors

ANDA 064046BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001OINTMENT;OPHTHALMIC500 UNITS/GM;10,000 UNITS/GM0BACITRACIN ZINC AND POLYMYXIN B SULFATEBACITRACIN ZINC; POLYMYXIN B SULFATE

FDA Submissions

ORIG1AP1995-01-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-06-20
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-05-04
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1998-10-22
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1999-05-26
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2000-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2000-06-27
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2001-03-07
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2001-11-27
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-08-05

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64046
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BACITRACIN ZINC AND POLYMYXIN B SULFATE","activeIngredients":"BACITRACIN ZINC; POLYMYXIN B SULFATE","strength":"500 UNITS\/GM;10,000 UNITS\/GM","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BACITRACIN ZINC AND POLYMYXIN B SULFATE","submission":"BACITRACIN ZINC; POLYMYXIN B SULFATE","actionType":"500 UNITS\/GM;10,000 UNITS\/GM","submissionClassification":"OINTMENT;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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