Documents
Application Sponsors
ANDA 077869 | INVAGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | CAPSULE;ORAL | 25MG | 0 | ZONISAMIDE | ZONISAMIDE |
002 | CAPSULE;ORAL | 50MG | 0 | ZONISAMIDE | ZONISAMIDE |
003 | CAPSULE;ORAL | 100MG | 0 | ZONISAMIDE | ZONISAMIDE |
FDA Submissions
| ORIG | 1 | AP | 2006-05-31 | |
LABELING; Labeling | SUPPL | 2 | AP | 2012-06-07 | |
LABELING; Labeling | SUPPL | 3 | AP | 2015-06-13 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2016-02-26 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2020-03-12 | STANDARD |
LABELING; Labeling | SUPPL | 14 | AP | 2022-05-25 | STANDARD |
Submissions Property Types
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 7 |
SUPPL | 7 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 14 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
INVAGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 77869
[companyName] => INVAGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)