NDA 050804

BAUSCH AND LOMB

FDA Drug Application

Application #050804

Documents

• Letter: 2004-12-30
• Letter: 2010-06-08
• Label: 2004-12-30
• Label: 2012-10-04
• Label: 2013-02-08
• Letter: 2012-10-04
• Letter: 2013-02-08
• Label: 2010-06-07
• Review: 2005-06-23
• Pediatric Written Request: 2010-12-28
• Pediatric Amendment 1: 2010-12-28
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Letter: 2021-10-26
• Label: 2021-10-26

Application Sponsors

NDA 050804

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.5%;0.3%

1

ZYLET

LOTEPREDNOL ETABONATE; TOBRAMYCIN

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2004-12-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2006-08-07	N/A
LABELING; Labeling	SUPPL	15	AP	2010-06-03	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2012-10-02	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2013-02-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2013-10-09	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-10-25	STANDARD

Submissions Property Types

ORIG	1	Null	31
SUPPL	15	Null	31
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	20	Null	0
SUPPL	26	Null	7

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50804
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYLET","activeIngredients":"LOTEPREDNOL ETABONATE; TOBRAMYCIN","strength":"0.5%;0.3%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/06\/2013","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/050804s018lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2012","submission":"SUPPL-17","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/050804s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2010","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/050804s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/050804lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZYLET","submission":"LOTEPREDNOL ETABONATE; TOBRAMYCIN","actionType":"0.5%;0.3%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-02-06
        )

)