Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 20MG/VIAL | 0 | PADCEV | ENFORTUMAB VEDOTIN-EJFV |
| 002 | INJECTABLE;INJECTION | 30MG/VIAL | 0 | PADCEV | ENFORTUMAB VEDOTIN-EJFV |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-12-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-07-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 7 | AP | 2021-03-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2021-07-09 | PRIORITY |
| LABELING; Labeling | SUPPL | 17 | AP | 2022-10-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 7 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 17 | Null | 46 |
CDER Filings
ASTELLAS
cder:Array
(
[0] => Array
(
[ApplNo] => 761137
[companyName] => ASTELLAS
[docInserts] => ["",""]
[products] => [{"drugName":"PADCEV","activeIngredients":"ENFORTUMAB VEDOTIN-EJFV","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PADCEV","activeIngredients":"ENFORTUMAB VEDOTIN-EJFV","strength":"30MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761137s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761137s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761137Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761137Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2019-12-18
)
)