Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Discontinued | 003 |
Application Products
| 001 | CAPSULE;ORAL | 15MG | 1 | TOPAMAX | TOPIRAMATE |
| 002 | CAPSULE;ORAL | 25MG | 1 | TOPAMAX | TOPIRAMATE |
| 003 | CAPSULE;ORAL | 50MG | 0 | TOPAMAX SPRINKLE | TOPIRAMATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 1998-10-26 | STANDARD |
| LABELING; Labeling | SUPPL | 2 | AP | 2000-05-01 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 1999-10-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 2000-01-04 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2003-12-16 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2000-10-26 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2000-10-24 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 2001-02-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 10 | AP | 2001-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2009-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2003-06-03 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2002-11-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2003-12-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 15 | AP | 2005-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2003-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 17 | AP | 2003-06-12 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2003-04-15 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 19 | AP | 2004-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2003-04-15 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2004-08-11 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2005-06-29 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2006-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2009-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2009-12-22 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2009-04-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 31 | AP | 2009-12-22 | PRIORITY |
| LABELING; Labeling | SUPPL | 32 | AP | 2009-04-23 | 901 REQUIRED |
| LABELING; Labeling | SUPPL | 34 | AP | 2009-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 35 | AP | 2011-03-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 36 | AP | 2011-07-15 | STANDARD |
| LABELING; Labeling | SUPPL | 37 | AP | 2011-03-04 | STANDARD |
| REMS; REMS | SUPPL | 38 | AP | 2011-06-27 | N/A |
| LABELING; Labeling | SUPPL | 41 | AP | 2012-10-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 43 | AP | 2014-03-28 | STANDARD |
| LABELING; Labeling | SUPPL | 44 | AP | 2014-01-29 | STANDARD |
| LABELING; Labeling | SUPPL | 45 | AP | 2014-10-21 | STANDARD |
| LABELING; Labeling | SUPPL | 46 | AP | 2014-12-18 | STANDARD |
| LABELING; Labeling | SUPPL | 48 | AP | 2017-05-12 | STANDARD |
| LABELING; Labeling | SUPPL | 49 | AP | 2018-06-19 | STANDARD |
| LABELING; Labeling | SUPPL | 50 | AP | 2018-12-27 | STANDARD |
| LABELING; Labeling | SUPPL | 51 | AP | 2019-05-02 | STANDARD |
| LABELING; Labeling | SUPPL | 52 | AP | 2020-06-08 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 53 | AP | 2022-01-13 | STANDARD |
| LABELING; Labeling | SUPPL | 54 | AP | 2021-06-30 | STANDARD |
| LABELING; Labeling | SUPPL | 55 | AP | 2022-10-20 | STANDARD |
Submissions Property Types
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 26 | Null | 7 |
| SUPPL | 27 | Null | 6 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 34 | Null | 7 |
| SUPPL | 35 | Null | 6 |
| SUPPL | 36 | Null | 6 |
| SUPPL | 37 | Null | 6 |
| SUPPL | 38 | Null | 6 |
| SUPPL | 41 | Null | 7 |
| SUPPL | 43 | Null | 7 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 7 |
| SUPPL | 46 | Null | 15 |
| SUPPL | 48 | Null | 15 |
| SUPPL | 49 | Null | 31 |
| SUPPL | 50 | Null | 6 |
| SUPPL | 51 | Null | 6 |
| SUPPL | 52 | Null | 7 |
| SUPPL | 53 | Null | 7 |
| SUPPL | 54 | Null | 6 |
| SUPPL | 55 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 20844
[companyName] => JANSSEN PHARMS
[docInserts] => ["Medication Guide",""]
[products] => [{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"TOPAMAX","activeIngredients":"TOPIRAMATE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"TOPAMAX SPRINKLE","activeIngredients":"TOPIRAMATE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/30\/2021","submission":"SUPPL-54","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-52","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-51","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-50","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020505s59_020844s50lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2018","submission":"SUPPL-49","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020505s058,020844s049lbl.pdf\"}]","notes":""},{"actionDate":"05\/12\/2017","submission":"SUPPL-48","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020505s057_020844s048lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2014","submission":"SUPPL-46","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/020505s055,020844s046lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2014","submission":"SUPPL-45","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-43","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-44","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-41","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020844s041lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2011","submission":"SUPPL-36","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-35","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-31","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s014s031s032s037,020844s011s026s027s031lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s014s031s032s037,020844s011s026s027s031lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s014s031s032s037,020844s011s026s027s031lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2009","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020505s014s031s032s037,020844s011s026s027s031lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-34","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-34","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-32","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-30","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-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020844s015S022lbl.pdf\"}]","notes":""},{"actionDate":"06\/29\/2005","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020844s015S022lbl.pdf\"}]","notes":""},{"actionDate":"08\/11\/2004","submission":"SUPPL-19","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-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2003","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2003","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20844slr006,016,s2-014,20505s010,19s2-017_Topamax_lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2001","submission":"SUPPL-10","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20505S002lbl.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\\\/20844S1_Topamax_appltr_prntlbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20844lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TOPAMAX","submission":"TOPIRAMATE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"TOPAMAX SPRINKLE","submission":"TOPIRAMATE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2021-06-30
)
)