NDA 200738

BAUSCH AND LOMB

FDA Drug Application

Application #200738

Documents

• Label: 2011-04-18
• Letter: 2011-04-20
• Review: 2011-09-09
• Summary Review: 2011-09-09
• Letter: 2020-12-09
• Label: 2020-12-14

Application Sponsors

NDA 200738

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;OPHTHALMIC

0.5%

1

LOTEMAX

LOTEPREDNOL ETABONATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-04-15	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-12-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7

CDER Filings

BAUSCH AND LOMB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200738
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEMAX","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"OINTMENT;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/15\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/200738s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/15\/2011","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\\\/2011\\\/200738s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200738s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200738_lotemax_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/200738Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2011-04-15
        )

)