Documents
Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 40MG | 0 | TIVDAK | TISOTUMAB VEDOTIN-TFTV |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-09-20 | PRIORITY |
Submissions Property Types
CDER Filings
SEAGEN
cder:Array
(
[0] => Array
(
[ApplNo] => 761208
[companyName] => SEAGEN
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761208s000lbl.pdf#page=21"]
[products] => [{"drugName":"TIVDAK","activeIngredients":"TISOTUMAB VEDOTIN-TFTV","strength":"40MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"09\/20\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761208s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761208s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761208Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-09-20
)
)