topiramate Extended Release Oral Capsule

Brand(s)
Qudexy, Trokendi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Upsher-Smith Laboratories, Inc. (2015-04-08)
Oldest Current Product
2013-08-16
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
EXTENDED RELEASE ORAL CAPSULE\TOPIRAMATE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\TOPIRAMATE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\TOPIRAMATE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\TOPIRAMATE

product(s) by strength(s)

24 hr topiramate 100 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002451074QudexyNDAUpsher-Smith Laboratories, Inc.2014-04-11TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA20512246f54677-3a22-4c38-9b92-923020164e15

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008321074NDA AUTHORIZED GENERICUpsher-Smith Laboratories, Inc.2014-07-07TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA205122691d276c-9cc1-4d39-828f-0f44d7ef6328

24 hr topiramate 150 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002451075QudexyNDAUpsher-Smith Laboratories, Inc.2014-04-11TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA20512246f54677-3a22-4c38-9b92-923020164e15

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008321075NDA AUTHORIZED GENERICUpsher-Smith Laboratories, Inc.2014-07-07TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA205122691d276c-9cc1-4d39-828f-0f44d7ef6328

24 hr topiramate 200 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1177720104TrokendiNDASupernus2013-08-16TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA2016352dc7957e-a3e5-46bb-aa66-f3250f872f5e

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008321073NDA AUTHORIZED GENERICUpsher-Smith Laboratories, Inc.2014-07-07TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA205122691d276c-9cc1-4d39-828f-0f44d7ef6328

24 hr topiramate 25 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002451071QudexyNDAUpsher-Smith Laboratories, Inc.2014-04-11TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA20512246f54677-3a22-4c38-9b92-923020164e15

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008321071NDA AUTHORIZED GENERICUpsher-Smith Laboratories, Inc.2014-07-07TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA205122691d276c-9cc1-4d39-828f-0f44d7ef6328

24 hr topiramate 50 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002451072QudexyNDAUpsher-Smith Laboratories, Inc.2014-04-11TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA20512246f54677-3a22-4c38-9b92-923020164e15

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008321072NDA AUTHORIZED GENERICUpsher-Smith Laboratories, Inc.2014-07-07TOPIRAMATEORALCAPSULE, EXTENDED RELEASENDA205122691d276c-9cc1-4d39-828f-0f44d7ef6328

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA201635TROKENDI XRSUPERNUS PHARMACEUTICALS INC2013-08-16p8877248, TREATMENT OF EPILEPSY, SUBSTANCE
p8663683, TREATMENT OF EPILEPSY, SUBSTANCE
p8992989, USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY, SUBSTANCE
p8298580, TREATMENT OF EPILEPSY, SUBSTANCE
p8889191, TREATMENT OF EPILEPSY
p8298576, TREATMENT OF EPILEPSY, SUBSTANCE
NDA201635_001, NDA201635_002, NDA201635_003, NDA201635_004
2NDA205122QUDEXY XRUPSHER SMITH LABORATORIES INC2014-03-11p9101545, SUBSTANCE
p8652527, SUBSTANCE
p8889190, SUBSTANCE
NDA205122_001, NDA205122_002, NDA205122_003, NDA205122_004, NDA205122_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201635_001RXTOPIRAMATE (25MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-08-16TROKENDI XR
2NDA201635_002RXTOPIRAMATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-08-16TROKENDI XR
3NDA201635_003RXTOPIRAMATE (100MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-08-16TROKENDI XR
4NDA201635_004RXTOPIRAMATE (200MG)ORALCAPSULE, EXTENDED RELEASETrue2013-08-16TROKENDI XR
5NDA205122_001RXTOPIRAMATE (25MG)ORALCAPSULE, EXTENDED RELEASEFalse2014-03-11QUDEXY XR
6NDA205122_002RXTOPIRAMATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalse2014-03-11QUDEXY XR
7NDA205122_003RXTOPIRAMATE (100MG)ORALCAPSULE, EXTENDED RELEASEFalse2014-03-11QUDEXY XR
8NDA205122_004RXTOPIRAMATE (150MG)ORALCAPSULE, EXTENDED RELEASEFalse2014-03-11QUDEXY XR
9NDA205122_005RXTOPIRAMATE (200MG)ORALCAPSULE, EXTENDED RELEASETrue2014-03-11QUDEXY XR

patent(s)

#idexpiration dateapplication(s)
1p8298576 (view patent)2028-04-04NDA201635
2p8298580 (view patent)2027-11-16NDA201635
3p8652527 (view patent)2033-03-19NDA205122
4p8663683 (view patent)2027-11-16NDA201635
5p8877248 (view patent)2027-11-16NDA201635
6p8889190 (view patent)2033-03-19NDA205122
7p8889191 (view patent)2027-11-16NDA201635
8p8992989 (view patent)2027-11-16NDA201635
9p9101545 (view patent)2033-03-19NDA205122

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12dc7957e-a3e5-46bb-aa66-f3250f872f5e (view SPL)These highlights do not include all the information needed to use TROKENDI XR safely and effectively. See full prescribing information for TROKENDI XR. TROKENDI XR (topiramate) extended-release capsules, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionSupernusANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-06-262177720104, 177720101, 177720102, 177720103
246f54677-3a22-4c38-9b92-923020164e15 (view SPL)These highlights do not include all the information needed to use QUDEXY XR safely and effectively. See full prescribing information for QUDEXY XR. QUDEXY XR (topiramate) extended-release capsules, for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL2015-10-286002451071, 002451072, 002451074, 002451075, 002451073
3691d276c-9cc1-4d39-828f-0f44d7ef6328 (view SPL)These highlights do not include all the information needed to use Topiramate Extended-Release Capsules safely and effectively. See full prescribing information for Topiramate Extended-Release Capsules. Topiramate Extended-Release Capsules, for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, PACK2015-04-085008321071, 008321072, 008321073, 008321074, 008321075

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII