Documents
Application Sponsors
| NDA 020789 | SUNOVION PHARMS INC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
| Prescription | 003 |
Application Products
| 001 | CAPSULE;ORAL | 100MG | 1 | ZONEGRAN | ZONISAMIDE |
| 002 | CAPSULE;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | ZONEGRAN | ZONISAMIDE |
| 003 | CAPSULE;ORAL | 25MG | 1 | ZONEGRAN | ZONISAMIDE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2000-03-27 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-12-04 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-11-28 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2002-02-06 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2002-10-07 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 2002-04-01 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 2002-05-15 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 2002-06-13 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2012-01-26 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2006-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 21 | AP | 2015-06-19 | STANDARD |
| REMS; REMS | SUPPL | 22 | AP | 2009-04-23 | N/A |
| LABELING; Labeling | SUPPL | 24 | AP | 2010-04-19 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2009-04-23 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2010-04-19 | STANDARD |
| REMS; REMS | SUPPL | 29 | AP | 2011-05-27 | N/A |
| LABELING; Labeling | SUPPL | 30 | AP | 2011-09-23 | UNKNOWN |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2013-10-11 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2015-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2016-04-06 | STANDARD |
| LABELING; Labeling | SUPPL | 36 | AP | 2020-04-13 | 901 REQUIRED |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 21 | Null | 7 |
| SUPPL | 24 | Null | 6 |
| SUPPL | 25 | Null | 7 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 15 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 15 |
| SUPPL | 36 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
SUNOVION PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 20789
[companyName] => SUNOVION PHARMS INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/020789s036lbl.pdf#page=25"]
[products] => [{"drugName":"ZONEGRAN","activeIngredients":"ZONISAMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZONEGRAN","activeIngredients":"ZONISAMIDE","strength":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZONEGRAN","activeIngredients":"ZONISAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"04\/13\/2020","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/020789s036lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020789s034lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2015","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020789s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2012","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020789s012lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020789s030lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-30","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020789s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2010","submission":"SUPPL-26","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020789s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2010","submission":"SUPPL-26","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020789s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2010","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020789s024lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-25","supplementCategories":"REMS-Proposal","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"04\/23\/2009","submission":"SUPPL-22","supplementCategories":"REMS","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020789s022s025lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2006","submission":"SUPPL-19","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020789s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2003","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/20789scm001_zonegran_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/07\/2002","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/20789s5lbl.pdf\"}]","notes":""},{"actionDate":"03\/27\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20789lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"ZONEGRAN","submission":"ZONISAMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZONEGRAN","submission":"ZONISAMIDE","actionType":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"ZONEGRAN","submission":"ZONISAMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-04-13
)
)