BAUSCH AND LOMB FDA Approval ANDA 064067

ANDA 064067

BAUSCH AND LOMB

FDA Drug Application

Application #064067

Application Sponsors

ANDA 064067BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001OINTMENT;OPHTHALMIC0.5%0ERYTHROMYCINERYTHROMYCIN

FDA Submissions

ORIG1AP1994-07-29
LABELING; LabelingSUPPL2AP1996-09-24
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-01-31
LABELING; LabelingSUPPL4AP1997-05-21
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1998-10-22
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1998-05-04
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1999-03-31
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1999-03-31
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1999-06-07
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2000-05-01
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)SUPPL16AP2002-08-20

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0

TE Codes

001PrescriptionAT

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 64067
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ERYTHROMYCIN","activeIngredients":"ERYTHROMYCIN","strength":"0.5%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ERYTHROMYCIN","submission":"ERYTHROMYCIN","actionType":"0.5%","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.