Application Sponsors
ANDA 204713 | ASPEN GLOBAL INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 0.5MG | 0 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE |
002 | TABLET;ORAL | 1MG | 0 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE |
003 | TABLET;ORAL | 2MG | 0 | BENZTROPINE MESYLATE | BENZTROPINE MESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2015-04-14 | |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
003 | Prescription | AA |
CDER Filings
ASPEN GLOBAL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 204713
[companyName] => ASPEN GLOBAL INC
[docInserts] => ["",""]
[products] => [{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"BENZTROPINE MESYLATE","activeIngredients":"BENZTROPINE MESYLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/14\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-04-14
)
)