Application Sponsors
ANDA 202675 | AUROLIFE PHARMA LLC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 1MG | 0 | GLYCOPYRROLATE | GLYCOPYRROLATE |
002 | TABLET;ORAL | 2MG | 0 | GLYCOPYRROLATE | GLYCOPYRROLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2013-04-15 | |
UNKNOWN; | ORIG | 2 | AP | 2018-10-30 | |
Submissions Property Types
TE Codes
001 | Prescription | AA |
002 | Prescription | AA |
CDER Filings
AUROLIFE PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 202675
[companyName] => AUROLIFE PHARMA LLC
[docInserts] => ["",""]
[products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/30\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-10-30
)
)