Documents
Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 5MG;5MG | 0 | ENTADFI | FINASTERIDE;TADALAFIL |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2021-12-09 | STANDARD |
Submissions Property Types
CDER Filings
VERU INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215423
[companyName] => VERU INC
[docInserts] => ["",""]
[products] => [{"drugName":"ENTADFI","activeIngredients":"FINASTERIDE;TADALAFIL","strength":"5MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/09\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215423s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/215423s000lbl.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-12-09
)
)