NDA 208073

NOVARTIS

FDA Drug Application

Application #208073

Documents

• Letter: 2016-07-12
• Label: 2016-07-13
• Review: 2016-07-11
• Letter: 2017-12-20
• Label: 2017-12-21
• Label: 2020-06-05
• Letter: 2020-06-08

Application Sponsors

NDA 208073

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

5%

1

XIIDRA

LIFITEGRAST

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-07-11	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-12-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-06-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	5	Null	6

CDER Filings

NOVARTIS

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(
    [0] => Array
        (
            [ApplNo] => 208073
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"XIIDRA","activeIngredients":"LIFITEGRAST","strength":"5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/04\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208073s005lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208073s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208073s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208073s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208073Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208073Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/04\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/208073s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/208073Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"12\/17\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/208073s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208073Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-04
        )

)