BAUSCH AND LOMB FDA Approval NDA 022308

NDA 022308

BAUSCH AND LOMB

FDA Drug Application

Application #022308

Documents

Letter2009-06-02
Letter2012-09-24
Label2009-06-04
Label2012-09-20
Review2009-07-10
Summary Review2009-07-10
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Label2018-04-05
Letter2018-04-05

Application Sponsors

NDA 022308BAUSCH AND LOMB

Marketing Status

Prescription001

Application Products

001SUSPENSION/DROPS;OPHTHALMICEQ 0.6% BASE1BESIVANCEBESIFLOXACIN HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2009-05-28STANDARD
EFFICACY; EfficacySUPPL3AP2012-09-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2013-08-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2013-05-10STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2013-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2014-04-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2014-09-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2015-04-07STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2015-11-10STANDARD
LABELING; LabelingSUPPL13AP2018-04-03STANDARD

Submissions Property Types

ORIG1Null6
SUPPL3Null15
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL13Null15

CDER Filings

BAUSCH AND LOMB
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22308
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"BESIVANCE","activeIngredients":"BESIFLOXACIN HYDROCHLORIDE","strength":"EQ 0.6% BASE","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/03\/2018","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022308s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2012","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022308s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/28\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022308lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BESIVANCE","submission":"BESIFLOXACIN HYDROCHLORIDE","actionType":"EQ 0.6% BASE","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-04-03
        )

)

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