NDA 208711

NOVARTIS

FDA Drug Application

Application #208711

Documents

• Label: 2019-02-27
• Letter: 2019-02-14
• Review: 2019-03-11
• Label: 2022-02-18
• Letter: 2022-02-22

Application Sponsors

NDA 208711

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

250MG

1

EGATEN

TRICLABENDAZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-02-13	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2022-02-17	STANDARD

Submissions Property Types

ORIG	1	Null	10
SUPPL	2	Null	6

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208711
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EGATEN","activeIngredients":"TRICLABENDAZOLE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/17\/2022","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/208711s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208711s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208711s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208711Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208711Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/17\/2022","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/208711s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/208711Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-02-17
        )

)