NDA 020583

BAUSCH AND LOMB

FDA Drug Application

Application #020583

Documents

• Review: 2015-11-18
• Review: 2015-11-18
• Letter: 1998-03-09
• Label: 1998-03-09
• Review: 2002-04-09

Application Sponsors

NDA 020583

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.5%

1

LOTEMAX

LOTEPREDNOL ETABONATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-03-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-08-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2001-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2006-07-11	N/A
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2013-10-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-12-16	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20583
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEMAX","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/09\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20583lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LOTEMAX","submission":"LOTEPREDNOL ETABONATE","actionType":"0.5%","submissionClassification":"SUSPENSION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1998-03-09
        )

)