Documents
Application Sponsors
NDA 213969 | EIGER BIOPHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 50MG | 1 | ZOKINVY | LONAFARNIB |
002 | CAPSULE;ORAL | 75MG | 1 | ZOKINVY | LONAFARNIB |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-11-20 | PRIORITY |
Submissions Property Types
CDER Filings
EIGER BIOPHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 213969
[companyName] => EIGER BIOPHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ZOKINVY","activeIngredients":"LONAFARNIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZOKINVY","activeIngredients":"LONAFARNIB","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"11\/20\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213969s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213969s000lbl.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-11-20
)
)