NDA 203491

NOVARTIS

FDA Drug Application

Application #203491

Documents

• Letter: 2012-10-18
• Letter: 2012-12-19
• Letter: 2014-07-08
• Label: 2012-10-17
• Summary Review: 2013-04-08
• Label: 2012-12-18
• Review: 2013-04-08

Application Sponsors

NDA 203491

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.3%

1

ILEVRO

NEPAFENAC

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2012-10-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-02-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2013-12-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2014-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-09-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2015-11-10	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203491
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ILEVRO","activeIngredients":"NEPAFENAC","strength":"0.3%","dosageForm":"SUSPENSION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/14\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203491s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203491s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/16\/2012","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\\\/2012\\\/203491s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203491Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203491_nepafenac_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203491Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/10\/2015","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/28\/2015","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/03\/2014","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203491Orig1s006ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/09\/2013","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/13\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/05\/2014","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/14\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203491s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203491Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2015-11-10
        )

)