topiramate Oral Capsule

Brand(s)
Topamax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-12-23)
Oldest Current Product
1998-11-01
License(s)
NDA, ANDA
RxNORM
ORAL CAPSULE\TOPIRAMATE
FDAOB
ORAL\CAPSULE\TOPIRAMATE
SPL Active
ORAL\CAPSULE, COATED PELLETS\TOPIRAMATE
SPL Moiety
ORAL\CAPSULE, COATED PELLETS\TOPIRAMATE

product(s) by strength(s)

topiramate 15 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580647TopamaxNDAJanssen Pharmaceuticals, Inc.1998-11-01TOPIRAMATEORALCAPSULE, COATED PELLETSNDA02084421628112-0c47-11df-95b3-498d55d89593

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937335ANDATeva Pharmaceuticals Usa Inc2009-04-17TOPIRAMATEORALCAPSULE, COATED PELLETSANDA0765751f5f940c-d5b9-4d09-958d-246931e167af
2162520568ANDAActavis Pharma, Inc.2009-04-15TOPIRAMATEORALCAPSULE, COATED PELLETSANDA077868756e6ebc-36fa-b6ac-a228-9d86d0ab8256
3658410651ANDACadila Healthcare Limited2009-10-14TOPIRAMATEORALCAPSULE, COATED PELLETSANDA0788776f9d59e3-d10d-48f3-af01-83ba3e1e3a2b
4683820004ANDAZydus Pharmaceuticals (Usa) Inc.2009-10-14TOPIRAMATEORALCAPSULE, COATED PELLETSANDA078877e4886adf-199d-4b19-a4ef-75f8f94cb54e

topiramate 25 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580645TopamaxNDAJanssen Pharmaceuticals, Inc.1998-11-01TOPIRAMATEORALCAPSULE, COATED PELLETSNDA02084421628112-0c47-11df-95b3-498d55d89593

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937336ANDATeva Pharmaceuticals Usa Inc2009-04-17TOPIRAMATEORALCAPSULE, COATED PELLETSANDA0765751f5f940c-d5b9-4d09-958d-246931e167af
2162520569ANDAActavis Pharma, Inc.2009-04-15TOPIRAMATEORALCAPSULE, COATED PELLETSANDA077868756e6ebc-36fa-b6ac-a228-9d86d0ab8256

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1606870108ANDAAmerican Health Packaging2015-03-31TOPIRAMATEORALCAPSULE, COATED PELLETS000937336ANDA07657548619df9-4bbd-4789-8d86-8646edb7daa5

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA076448TOPIRAMATETrueBARR LABORATORIES INC2009-04-15ANDA076448_001, ANDA076448_002topiramate Oral Tablet
2ANDA076575TOPIRAMATETEVA PHARMACEUTICALS USA INC2009-04-17ANDA076575_001, ANDA076575_002topiramate Oral Tablet
3ANDA077868TOPIRAMATEWATSON LABORATORIES INC2009-04-15ANDA077868_001, ANDA077868_002topiramate Oral Tablet
4ANDA078418TOPIRAMATEMYLAN PHARMACEUTICALS INC2009-10-14ANDA078418_001, ANDA078418_002topiramate Oral Tablet
5ANDA078877TOPIRAMATEZYDUS PHARMACEUTICALS USA INC2009-10-14ANDA078877_001, ANDA078877_002topiramate Oral Tablet
6ANDA079206TOPIRAMATETrueSANDOZ INC2009-10-14ANDA079206_001, ANDA079206_002topiramate Oral Tablet
7NDA020844TOPAMAXJANSSEN PHARMACEUTICALS INC1998-10-26p7018983, PROPHYLACTIC TREATMENT OF MIGRAINE
p5998380, PROPHYLACTIC TREATMENT OF MIGRAINE
p6503884, PROPHYLACTIC TREATMENT OF MIGRAINE
p7125560, TREATMENT OF SEIZURES
p7498311, PROPHYLACTIC TREATMENT OF MIGRAINE
NEW PATIENT POPULATION [2017-03-28]
NEW PATIENT POPULATION [2014-07-15]
NDA020844_001, NDA020844_002, NDA020844_003topiramate Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076448_001discontinuedTOPIRAMATE (15MG)ORALCAPSULEFalse2009-04-15TOPIRAMATE
2ANDA076448_002discontinuedTOPIRAMATE (25MG)ORALCAPSULEFalse2009-04-15TOPIRAMATE
3ANDA076575_001RXTOPIRAMATE (15MG)ORALCAPSULEFalseAB2009-04-17TOPIRAMATE
4ANDA076575_002RXTOPIRAMATE (25MG)ORALCAPSULEFalseAB2009-04-17TOPIRAMATE
5ANDA077868_001RXTOPIRAMATE (15MG)ORALCAPSULEFalseAB2009-04-15TOPIRAMATE
6ANDA077868_002RXTOPIRAMATE (25MG)ORALCAPSULEFalseAB2009-04-15TOPIRAMATE
7ANDA078418_001RXTOPIRAMATE (15MG)ORALCAPSULEFalseAB2009-10-14TOPIRAMATE
8ANDA078418_002RXTOPIRAMATE (25MG)ORALCAPSULEFalseAB2009-10-14TOPIRAMATE
9ANDA078877_001RXTOPIRAMATE (15MG)ORALCAPSULEFalseAB2009-10-14TOPIRAMATE
10ANDA078877_002RXTOPIRAMATE (25MG)ORALCAPSULEFalseAB2009-10-14TOPIRAMATE
11ANDA079206_001discontinuedTOPIRAMATE (15MG)ORALCAPSULEFalse2009-10-14TOPIRAMATE
12ANDA079206_002discontinuedTOPIRAMATE (25MG)ORALCAPSULEFalse2009-10-14TOPIRAMATE
13NDA020844_001RXTOPIRAMATE (15MG)ORALCAPSULEFalseAB1998-10-26TOPAMAX
14NDA020844_002RXTOPIRAMATE (25MG)ORALCAPSULETrueAB1998-10-26TOPAMAX
15NDA020844_003discontinuedTOPIRAMATE (50MG)ORALCAPSULEFalse1998-10-26TOPAMAX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5998380 (view patent)2015-10-13NDA020844, NDA020505topiramate Oral Tablet
Hydrochlorothiazide / Losartan Oral Tablet
2p6503884 (view patent)2015-10-13NDA020844, NDA020505topiramate Oral Tablet
Hydrochlorothiazide / Losartan Oral Tablet
3p7018983 (view patent)2015-10-13NDA020844, NDA020505topiramate Oral Tablet
Hydrochlorothiazide / Losartan Oral Tablet
4p7125560 (view patent)2019-03-01NDA020844topiramate Oral Tablet
5p7498311 (view patent)2015-10-13NDA020844, NDA020505topiramate Oral Tablet
Hydrochlorothiazide / Losartan Oral Tablet

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
11f5f940c-d5b9-4d09-958d-246931e167af (view SPL)These highlights do not include all the information needed to use TOPIRAMATE CAPSULES (SPRINKLE) safely and effectively. See full prescribing information for TOPIRAMATE CAPSULES (SPRINKLE). TOPIRAMATE capsules (sprinkle), for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-11-0914000937335, 000937336
221628112-0c47-11df-95b3-498d55d89593 (view SPL)These highlights do not include all the information needed to use TOPAMAX safely and effectively. See full prescribing information for TOPAMAX TOPAMAX (topiramate) TABLETS, for oral use TOPAMAX (topiramate capsules) SPRINKLE CAPSULES, for oral use Initial U.S. Approval : 1996prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-12-2314504580645, 504580647, 504580639, 504580640, 504580641, 504580642topiramate Oral Tablet
348619df9-4bbd-4789-8d86-8646edb7daa5 (view SPL)These highlights do not include all the information needed to use Topiramate Capsules (Sprinkle) safely and effectively. See full prescribing information for Topiramate Capsules (Sprinkle). TOPIRAMATE Capsules (Sprinkle) for oral use Initial U.S. Approval: 1996prescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-03-311606870108
46f9d59e3-d10d-48f3-af01-83ba3e1e3a2b (view SPL)These highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate. Initial U.S. Approval-1996prescriptionHuman PrescriptionCadila Healthcare LimitedAnalysis, Manufacture2011-11-303658410651
5756e6ebc-36fa-b6ac-a228-9d86d0ab8256 (view SPL)These highlights do not include all the information needed to use topiramate capsules (sprinkle) safely and effectively. See full prescribing information for topiramate capsules (sprinkle) TOPIRAMATE CAPSULES (SPRINKLE) for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionActavis Pharma, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK2013-01-0111162520568, 162520569
6e4886adf-199d-4b19-a4ef-75f8f94cb54e (view SPL)These highlights do not include all the information needed to use [topiramate] safely and effectively. See full prescribing information for [topiramate]. TOPIRAMATE tablets USP, for oral useTOPIRAMATE capsules (Sprinkle), for oral useInitial U.S. Approval: 1996prescriptionHuman PrescriptionZydus Pharmaceuticals (Usa) Inc.analysis, manufacture2015-09-2611683820004

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