Documents
Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION;ORAL | 5MG/5ML(1MG/ML) | 2 | VESICARE LS | SOLIFENACIN SUCCINATE |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2020-05-26 | PRIORITY |
Submissions Property Types
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 209529
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"VESICARE LS","activeIngredients":"SOLIFENACIN SUCCINATE","strength":"5MG\/5ML(1MG\/ML)","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"05\/26\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209529s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/26\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209529s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209529Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-05-26
)
)