NDA 021737

BAUSCH AND LOMB

FDA Drug Application

Application #021737

Documents

• Letter: 2005-04-12
• Letter: 2010-12-03
• Letter: 2011-06-06
• Label: 2005-04-12
• Label: 2011-06-07
• Letter: 2007-11-08
• Letter: 2008-08-07
• Label: 2007-11-07
• Review: 2007-01-22

Application Sponsors

NDA 021737

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

IMPLANT;INTRAVITREAL

0.59MG

1

RETISERT

FLUOCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2004-11-04	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2007-10-30	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2008-08-05	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2010-11-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2011-06-02	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2014-06-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2015-03-30	PRIORITY

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	10	Null	6
SUPPL	18	Null	14
SUPPL	19	Null	6
SUPPL	21	Null	14
SUPPL	22	Null	14

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21737
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"RETISERT","activeIngredients":"FLUOCINOLONE ACETONIDE","strength":"0.59MG","dosageForm":"IMPLANT;INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/02\/2011","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021737s019.pdf\"}]","notes":""},{"actionDate":"10\/30\/2007","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021737s007lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021737lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RETISERT","submission":"FLUOCINOLONE ACETONIDE","actionType":"0.59MG","submissionClassification":"IMPLANT;INTRAVITREAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2011-06-02
        )

)