NDA 207145

US WORLDMEDS LLC

FDA Drug Application

Application #207145

Documents

• Label: 2017-03-22
• Letter: 2017-03-28
• Review: 2017-05-01
• Label: 2017-06-19
• Letter: 2017-06-20
• Letter: 2019-11-27
• Label: 2019-11-29
• Label: 2021-08-09
• Letter: 2021-08-10

Application Sponsors

NDA 207145

US WORLDMEDS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	1	XADAGO	SAFINAMIDE MESYLATE
002	TABLET;ORAL	100MG	1	XADAGO	SAFINAMIDE MESYLATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-03-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-11-25	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-08-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	6

CDER Filings

MDD US

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(
    [0] => Array
        (
            [ApplNo] => 207145
            [companyName] => MDD US
            [docInserts] => ["",""]
            [products] => [{"drugName":"XADAGO","activeIngredients":"SAFINAMIDE MESYLATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"XADAGO","activeIngredients":"SAFINAMIDE MESYLATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/25\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207145s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207145s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207145s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207145lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207145lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207145Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/207145Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/25\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207145s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207145Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2017","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207145s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207145Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-11-25
        )

)