Application Sponsors
ANDA 207302 | MACLEODS PHARMS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 7.5MG BASE | 0 | DARIFENACIN | DARIFENACIN HYDROBROMIDE |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 15MG BASE | 0 | DARIFENACIN | DARIFENACIN HYDROBROMIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-07-28 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 207302
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"DARIFENACIN","activeIngredients":"DARIFENACIN HYDROBROMIDE","strength":"EQ 7.5MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DARIFENACIN","activeIngredients":"DARIFENACIN HYDROBROMIDE","strength":"EQ 15MG BASE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2017-07-28
)
)