Application Sponsors
ANDA 209538 | TARO PHARM INDS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
None (Tentative Approval) | 004 |
None (Tentative Approval) | 005 |
None (Tentative Approval) | 006 |
Application Products
001 | TABLET;ORAL | 2MG | 0 | PERAMPANEL | PERAMPANEL |
002 | TABLET;ORAL | 4MG | 0 | PERAMPANEL | PERAMPANEL |
003 | TABLET;ORAL | 6MG | 0 | PERAMPANEL | PERAMPANEL |
004 | TABLET;ORAL | 8MG | 0 | PERAMPANEL | PERAMPANEL |
005 | TABLET;ORAL | 10MG | 0 | PERAMPANEL | PERAMPANEL |
006 | TABLET;ORAL | 12MG | 0 | PERAMPANEL | PERAMPANEL |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2018-12-27 | STANDARD |
Submissions Property Types
CDER Filings
TARO PHARM INDS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 209538
[companyName] => TARO PHARM INDS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PERAMPANEL","activeIngredients":"PERAMPANEL","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/27\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-12-27
)
)