Documents
Application Sponsors
NDA 213006 | UROVANT SCIENCES GMBH | |
Marketing Status
Application Products
001 | TABLET;ORAL | 75MG | 2 | GEMTESA | VIBEGRON |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-12-23 | STANDARD |
Submissions Property Types
CDER Filings
UROVANT SCIENCES GMBH
cder:Array
(
[0] => Array
(
[ApplNo] => 213006
[companyName] => UROVANT SCIENCES GMBH
[docInserts] => ["",""]
[products] => [{"drugName":"GEMTESA","activeIngredients":"VIBEGRON","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"12\/23\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213006s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/23\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213006s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213006Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-12-23
)
)