NDA 204822

NOVARTIS

FDA Drug Application

Application #204822

Documents

• Letter: 2014-05-20
• Label: 2014-05-19
• Review: 2015-06-26
• Summary Review: 2015-06-26
• Letter: 2021-06-10
• Label: 2021-06-11

Application Sponsors

NDA 204822

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

IZBA

TRAVOPROST

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2014-05-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-06-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204822
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IZBA","activeIngredients":"TRAVOPROST","strength":"0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"06\/09\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204822s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204822s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/15\/2014","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\\\/2014\\\/204822s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204822Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204822Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204822Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/09\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/204822s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/204822Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-06-09
        )

)