NDA 201635

SUPERNUS PHARMS

FDA Drug Application

Application #201635

Documents

• Letter: 2013-08-20
• Label: 2013-08-21
• Summary Review: 2014-06-24
• Letter: 2012-06-26
• Letter: 2013-06-11
• Letter: 2015-05-13
• Label: 2015-06-05
• Review: 2014-06-24
• Label: 2016-08-22
• Letter: 2016-08-18
• Letter: 2016-08-18
• Label: 2017-04-07
• Medication Guide: 2017-04-07
• Label: 2017-04-07
• Letter: 2017-04-12
• Letter: 2018-01-04
• Label: 2018-01-09
• Letter: 2019-02-22
• Label: 2019-02-22
• Label: 2020-11-19
• Medication Guide: 2020-11-19
• Letter: 2020-11-19
• Letter: 2022-02-04
• Label: 2022-02-07
• Medication Guide: 2022-02-07
• Letter: 2022-10-11
• Label: 2022-10-11
• Medication Guide: 2022-10-11

Application Sponsors

NDA 201635

SUPERNUS PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	25MG	1	TROKENDI XR	TOPIRAMATE
002	CAPSULE, EXTENDED RELEASE;ORAL	50MG	1	TROKENDI XR	TOPIRAMATE
003	CAPSULE, EXTENDED RELEASE;ORAL	100MG	1	TROKENDI XR	TOPIRAMATE
004	CAPSULE, EXTENDED RELEASE;ORAL	200MG	1	TROKENDI XR	TOPIRAMATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2013-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-06-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-04-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-05-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-10-12	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2017-04-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2016-03-16	STANDARD
EFFICACY; Efficacy	SUPPL	13	TA	2016-08-18	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2016-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2016-12-22	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2017-04-05	STANDARD
LABELING; Labeling	SUPPL	18	AP	2018-01-03	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-02-21	STANDARD
LABELING; Labeling	SUPPL	25	AP	2020-11-18	STANDARD
LABELING; Labeling	SUPPL	29	AP	2022-02-03	STANDARD
LABELING; Labeling	SUPPL	30	AP	2022-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	6
SUPPL	10	Null	0
SUPPL	11	Null	6
SUPPL	12	Null	0
SUPPL	14	Null	7
SUPPL	17	Null	6
SUPPL	18	Null	6
SUPPL	20	Null	6
SUPPL	25	Null	15
SUPPL	29	Null	6
SUPPL	30	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	BC

CDER Filings

SUPERNUS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201635
            [companyName] => SUPERNUS PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/201635s025lbl.pdf#page=49"]
            [products] => [{"drugName":"TROKENDI XR","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TROKENDI XR","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TROKENDI XR","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TROKENDI XR","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/18\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201635s025lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201635s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201635s020lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201635s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201635s018lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201635s011s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/05\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201635s011s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2016","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201635s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/08\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201635s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201635s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/16\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/201635s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201635Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201635Orig1s000ltr.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/201635Orig1s000TA_ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/201635Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/201635Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/18\/2020","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/201635s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/201635orig1s025ltr.pdf\"}]","notes":">"},{"actionDate":"02\/21\/2019","submission":"SUPPL-20","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/201635s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/201635Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"01\/03\/2018","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/201635s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/201635Orig1s018ltredt.pdf\"}]","notes":">"},{"actionDate":"04\/05\/2017","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201635s011s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/201635Orig1s011s017ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2016","submission":"SUPPL-15","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/18\/2016","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/201635s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201635Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"08\/18\/2016","submission":"SUPPL-13","supplementCategories":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2016","submission":"SUPPL-12","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/05\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/201635s011s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/201635Orig1s011TAltr.pdf\"}]","notes":">"},{"actionDate":"10\/12\/2015","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/08\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/201635s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/201635Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"04\/17\/2015","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/18\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/20\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/18\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-11-18
        )

)