Application Sponsors
ANDA 211701 | UNICHEM LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE |
002 | TABLET;ORAL | 10MG | 0 | SOLIFENACIN SUCCINATE | SOLIFENACIN SUCCINATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2019-08-27 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2021-01-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 211701
[companyName] => UNICHEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"SOLIFENACIN SUCCINATE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"SOLIFENACIN SUCCINATE","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-08-27
)
)