NDA 020505

JANSSEN PHARMS

FDA Drug Application

Application #020505

Documents

• Letter: 2004-06-28
• Letter: 2009-12-30
• Letter: 2003-12-19
• Letter: 2003-12-19
• Letter: 2003-06-22
• Letter: 2003-05-29
• Letter: 2004-08-12
• Letter: 2003-05-29
• Letter: 2004-08-12
• Letter: 2009-12-30
• Letter: 2009-05-04
• Letter: 2011-07-19
• Letter: 2012-11-01
• Letter: 2014-10-23
• Letter: 2014-12-19
• Label: 2003-12-29
• Label: 2004-08-12
• Label: 2004-08-12
• Label: 2010-01-04
• Label: 2009-05-12
• Label: 2011-03-04
• Label: 2011-07-18
• Label: 2011-03-04
• Label: 2014-01-31
• Label: 2014-12-19
• Review: 2004-09-10
• Review: 2012-02-28
• Letter: 1999-07-23
• Letter: 2001-08-28
• Letter: 1999-10-01
• Letter: 2003-06-08
• Letter: 2002-12-09
• Letter: 2005-07-08
• Letter: 2005-07-08
• Letter: 2006-10-23
• Letter: 2009-12-30
• Letter: 2009-12-30
• Letter: 2009-05-04
• Letter: 2011-03-08
• Letter: 2011-03-08
• Letter: 2014-04-02
• Letter: 2014-01-30
• Label: 1999-07-23
• Label: 2001-08-28
• Label: 1999-10-01
• Label: 2003-12-29
• Label: 2010-01-04
• Label: 2005-07-05
• Label: 2003-12-29
• Label: 2005-07-05
• Label: 2010-01-04
• Label: 2009-04-28
• Label: 2010-01-04
• Label: 2009-05-12
• Label: 2012-10-29
• Label: 2014-04-01
• Label: 2014-10-23
• Review: 2000-07-03
• Review: 2004-09-08
• Review: 2000-07-03
• Label: 2017-05-16
• Letter: 2017-05-17
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Amendment 1: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2018-06-21
• Label: 2018-06-26
• Label: 2018-12-28
• Letter: 2018-12-30
• Medication Guide: 2019-01-02
• Label: 2019-05-03
• Medication Guide: 2019-05-03
• Letter: 2019-05-03
• Letter: 2020-06-09
• Label: 2020-06-09
• Medication Guide: 2020-06-09
• Label: 2021-07-01
• Letter: 2021-07-01
• Medication Guide: 2021-07-07
• Letter: 2022-01-19
• Label: 2022-01-19
• Medication Guide: 2022-01-19
• Letter: 2022-10-21
• Label: 2022-10-24

Application Sponsors

NDA 020505

JANSSEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002
• Discontinued: 003
• Prescription: 004
• Prescription: 005
• Discontinued: 006

Application Products

001	TABLET;ORAL	100MG	1	TOPAMAX	TOPIRAMATE
002	TABLET;ORAL	200MG	1	TOPAMAX	TOPIRAMATE
003	TABLET;ORAL	300MG	0	TOPAMAX	TOPIRAMATE
004	TABLET;ORAL	25MG	1	TOPAMAX	TOPIRAMATE
005	TABLET;ORAL	50MG	1	TOPAMAX	TOPIRAMATE
006	TABLET;ORAL	400MG	0	TOPAMAX	TOPIRAMATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-12-24	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2001-08-28	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	1999-10-01	STANDARD
LABELING; Labeling	SUPPL	5	AP	2000-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-01-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	2003-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2000-05-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2000-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-10-24	STANDARD
LABELING; Labeling	SUPPL	14	AP	2009-12-22	STANDARD
LABELING; Labeling	SUPPL	15	AP	2003-06-03	STANDARD
LABELING; Labeling	SUPPL	16	AP	2002-11-26	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2003-12-16	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2005-06-29	STANDARD
LABELING; Labeling	SUPPL	19	AP	2003-12-16	STANDARD
LABELING; Labeling	SUPPL	20	AP	2003-06-12	STANDARD
LABELING; Labeling	SUPPL	21	AP	2003-04-15	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2004-08-11	STANDARD
LABELING; Labeling	SUPPL	23	AP	2003-04-15	STANDARD
LABELING; Labeling	SUPPL	25	AP	2004-08-11	STANDARD
LABELING; Labeling	SUPPL	26	AP	2005-06-29	STANDARD
LABELING; Labeling	SUPPL	29	AP	2006-10-19	STANDARD
LABELING; Labeling	SUPPL	31	AP	2009-12-22	STANDARD
LABELING; Labeling	SUPPL	32	AP	2009-12-22	STANDARD
LABELING; Labeling	SUPPL	36	AP	2009-04-22	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2009-12-22	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2009-04-23	901 REQUIRED
LABELING; Labeling	SUPPL	39	AP	2009-04-23	STANDARD
LABELING; Labeling	SUPPL	40	AP	2011-03-04	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	2011-07-15	STANDARD
LABELING; Labeling	SUPPL	45	AP	2011-03-04	STANDARD
REMS; REMS	SUPPL	46	AP	2011-06-27	N/A
LABELING; Labeling	SUPPL	50	AP	2012-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	2013-07-25	STANDARD
EFFICACY; Efficacy	SUPPL	52	AP	2014-03-28	STANDARD
LABELING; Labeling	SUPPL	53	AP	2014-01-29	STANDARD
LABELING; Labeling	SUPPL	54	AP	2014-10-21	STANDARD
LABELING; Labeling	SUPPL	55	AP	2014-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	57	AP	2017-05-12	STANDARD
LABELING; Labeling	SUPPL	58	AP	2018-06-19	STANDARD
LABELING; Labeling	SUPPL	59	AP	2018-12-27	STANDARD
LABELING; Labeling	SUPPL	60	AP	2019-05-02	STANDARD
LABELING; Labeling	SUPPL	61	AP	2020-06-08	STANDARD
EFFICACY; Efficacy	SUPPL	62	AP	2022-01-13	STANDARD
LABELING; Labeling	SUPPL	63	AP	2021-06-30	STANDARD
LABELING; Labeling	SUPPL	64	AP	2022-10-20	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	6
SUPPL	31	Null	6
SUPPL	32	Null	6
SUPPL	37	Null	8
SUPPL	39	Null	7
SUPPL	40	Null	6
SUPPL	42	Null	6
SUPPL	45	Null	7
SUPPL	46	Null	7
SUPPL	50	Null	6
SUPPL	51	Null	0
SUPPL	52	Null	15
SUPPL	53	Null	15
SUPPL	54	Null	6
SUPPL	55	Null	6
SUPPL	56	Null	0
SUPPL	57	Null	15
SUPPL	58	Null	31
SUPPL	59	Null	6
SUPPL	60	Null	6
SUPPL	61	Null	7
SUPPL	62	Null	7
SUPPL	63	Null	6
SUPPL	64	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

JANSSEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20505
            [companyName] => JANSSEN PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/020505s063,020844s054lbl.pdf#page=52"]
            [products] => [{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/30\/2021","submission":"SUPPL-63","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/020505s063,020844s054lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2020","submission":"SUPPL-61","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020505s061,020844s052lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2019","submission":"SUPPL-60","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020505s060,020844s051lbl.pdf\"}]","notes":""},{"actionDate":"12\/27\/2018","submission":"SUPPL-59","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020505s055,020844s046lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2014","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020505s054,020844s045lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2014","submission":"SUPPL-52","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020505s052,020844s043lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2014","submission":"SUPPL-53","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020505s053,020844s044lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2012","submission":"SUPPL-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020505s050lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2011","submission":"SUPPL-42","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020505s042,020844s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2011","submission":"SUPPL-45","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020505s040s045,020844s035s037lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2011","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020505s040s045,020844s035s037lbl.pdf\"}]","notes":""},{"actionDate":"03\/04\/2011","submission":"SUPPL-40","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020505s040s045,020844s035s037lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-37","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s014s031s032s037,020844s011s026s027s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-39","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s038s039,020844s032s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-39","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s038s039,020844s032s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-38","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s038s039,020844s032s034lbl.pdf\"}]","notes":""},{"actionDate":"04\/22\/2009","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s036,020844s030lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2005","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020505s018lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2005","submission":"SUPPL-18","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020505s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2004","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20505s022,025,20844s019,021lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2004","submission":"SUPPL-22","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20505s022,025,20844s019,021lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2003","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20505S002lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/1999","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20505S3_Topamax_appltr_prntlbl.pdf\"}]","notes":""},{"actionDate":"07\/23\/1999","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/20505S1_Topamax_appltr_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2021-06-30
        )

)