NDA 208219

BAUSCH AND LOMB INC

FDA Drug Application

Application #208219

Documents

• Label: 2019-03-01
• Letter: 2019-03-05
• Review: 2019-10-03

Application Sponsors

NDA 208219

BAUSCH AND LOMB INC

Marketing Status

• Prescription: 001

Application Products

001

GEL;OPHTHALMIC

0.38%

1

LOTEMAX SM

LOTEPREDNOL ETABONATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2019-02-22

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

BAUSCH AND LOMB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208219
            [companyName] => BAUSCH AND LOMB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEMAX SM","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.38%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208219s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208219s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208219Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/208219Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-02-22
        )

)