Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;SUBLINGUAL | EQ 2.5MG BASE | 0 | ASENAPINE MALEATE | ASENAPINE MALEATE |
002 | TABLET;SUBLINGUAL | EQ 10MG BASE | 0 | ASENAPINE MALEATE | ASENAPINE MALEATE |
003 | TABLET;SUBLINGUAL | EQ 5MG BASE | 0 | ASENAPINE MALEATE | ASENAPINE MALEATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-12-10 | STANDARD |
UNKNOWN; | ORIG | 2 | TA | 2020-12-10 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
BRECKENRIDGE
cder:Array
(
[0] => Array
(
[ApplNo] => 205960
[companyName] => BRECKENRIDGE
[docInserts] => ["",""]
[products] => [{"drugName":"ASENAPINE MALEATE","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ASENAPINE MALEATE","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/10\/2020","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/10\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-12-10
)
)