NDA 201367

EISAI INC

FDA Drug Application

Application #201367

Documents

• Letter: 2011-06-03
• Label: 2011-03-07
• Review: 2011-07-06
• Letter: 2011-03-08
• Letter: 2015-02-17
• Letter: 2015-06-26
• Label: 2015-03-03
• Label: 2015-07-01
• Summary Review: 2011-07-06
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Letter: 2019-11-29
• Medication Guide: 2019-11-29
• Label: 2019-11-29
• Pediatric Written Request: 1900-01-01

Application Sponsors

NDA 201367

EISAI INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

40MG/ML

1

BANZEL

RUFINAMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2011-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-01-05	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2015-02-12	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2015-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-11-28	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	14
SUPPL	3	Null	26
SUPPL	5	Null	6
SUPPL	6	Null	14
SUPPL	8	Null	15

TE Codes

001

Prescription

AB

CDER Filings

EISAI INC

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(
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            [companyName] => EISAI INC
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            [products] => [{"drugName":"BANZEL","activeIngredients":"RUFINAMIDE","strength":"40MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/28\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021911s017,201367s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/25\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/25\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"06\/25\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"02\/12\/2015","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021911s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/03\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/0201367,021911s007lbl.pdf\"}]","notes":""}]
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            [actionDate] => 2019-11-28
        )

)