NDA 207795

BAUSCH AND LOMB

FDA Drug Application

Application #207795

Documents

• Label: 2017-11-13
• Letter: 2017-11-20
• Review: 2017-12-18
• Letter: 2018-06-14
• Label: 2018-06-19

Application Sponsors

NDA 207795

BAUSCH AND LOMB

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.024%

1

VYZULTA

LATANOPROSTENE BUNOD

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-11-02	STANDARD
LABELING; Labeling	SUPPL	2	AP	2018-06-11	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6

CDER Filings

BAUSCH AND LOMB

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(
    [0] => Array
        (
            [ApplNo] => 207795
            [companyName] => BAUSCH AND LOMB
            [docInserts] => ["",""]
            [products] => [{"drugName":"VYZULTA","activeIngredients":"LATANOPROSTENE BUNOD","strength":"0.024%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/11\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207795s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207795s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207795Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/02\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207795Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207795Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/207795Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/11\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/207795s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/207795Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-06-11
        )

)