NDA 202872

BAUSCH AND LOMB INC

FDA Drug Application

Application #202872

Documents

• Label: 2012-10-01
• Review: 2012-12-04
• Letter: 2012-10-03
• Summary Review: 2012-12-04
• Letter: 2018-07-23
• Label: 2018-08-29
• Pediatric DD Summary Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 202872

BAUSCH AND LOMB INC

Marketing Status

• Prescription: 001

Application Products

001

GEL;OPHTHALMIC

0.5%

1

LOTEMAX

LOTEPREDNOL ETABONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2012-09-28	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2018-07-20	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

BAUSCH AND LOMB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202872
            [companyName] => BAUSCH AND LOMB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEMAX","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/20\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202872s002lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202872lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/28\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202872lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202872Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202872_lotemax_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202872Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/20\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202872s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202872Orig1s002Ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-07-20
        )

)