NDA 209080

ITALFARMACO SPA

FDA Drug Application

Application #209080

Documents

• Label: 2018-09-06
• Letter: 2018-09-12
• Review: 2019-03-11
• Label: 2019-12-16
• Letter: 2019-12-17
• Label: 2020-05-12
• Letter: 2020-05-13

Application Sponsors

NDA 209080

ITALFARMACO SPA

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

50MG/10ML

1

TIGLUTIK KIT

RILUZOLE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2018-09-05	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-05-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	6

CDER Filings

ITALFARMACO SPA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209080
            [companyName] => ITALFARMACO SPA
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIGLUTIK KIT","activeIngredients":"RILUZOLE","strength":"50MG\/10ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/11\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209080s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/13\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209080s001lbl.pdf\"}]","notes":""},{"actionDate":"09\/05\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209080s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/05\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209080s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209080Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209080Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/11\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209080s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209080Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"12\/13\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209080s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209080Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-05-11
        )

)