Application Sponsors
ANDA 204975 | DR REDDYS LABS LTD | |
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 4MG | 0 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE |
002 | TABLET, EXTENDED RELEASE;ORAL | 8MG | 0 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-08-13 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204975
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"FESOTERODINE FUMARATE","activeIngredients":"FESOTERODINE FUMARATE","strength":"4MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FESOTERODINE FUMARATE","activeIngredients":"FESOTERODINE FUMARATE","strength":"8MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/13\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-08-13
)
)