Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 150MG | 0 | OXCARBAZEPINE | OXCARBAZEPINE |
002 | TABLET;ORAL | 300MG | 0 | OXCARBAZEPINE | OXCARBAZEPINE |
003 | TABLET;ORAL | 600MG | 0 | OXCARBAZEPINE | OXCARBAZEPINE |
FDA Submissions
| ORIG | 1 | AP | 2008-04-09 | |
LABELING; Labeling | SUPPL | 3 | AP | 2010-04-29 | |
LABELING; Labeling | SUPPL | 4 | AP | 2010-10-22 | |
LABELING; Labeling | SUPPL | 6 | AP | 2013-04-26 | |
LABELING; Labeling | SUPPL | 7 | AP | 2014-12-19 | STANDARD |
LABELING; Labeling | SUPPL | 9 | AP | 2014-12-19 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2020-08-26 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2020-08-26 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2022-08-04 | UNKNOWN |
Submissions Property Types
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 7 |
SUPPL | 9 | Null | 7 |
SUPPL | 10 | Null | 7 |
SUPPL | 11 | Null | 15 |
SUPPL | 12 | Null | 15 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
RUBICON
cder:Array
(
[0] => Array
(
[ApplNo] => 77747
[companyName] => RUBICON
[docInserts] => ["",""]
[products] => [{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXCARBAZEPINE","activeIngredients":"OXCARBAZEPINE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"300MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OXCARBAZEPINE","submission":"OXCARBAZEPINE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)