Documents
Application Sponsors
BLA 761172 | RIDGEBACK BIOTHERAPEUTICS | |
Marketing Status
Application Products
001 | POWDER;IV (INFUSION) | 400MG/VIAL | 0 | EBANGA | ANSUVIMAB-ZYKL |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2020-12-21 | PRIORITY |
LABELING; Labeling | SUPPL | 2 | AP | 2021-12-07 | STANDARD |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2021-11-19 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 40 |
SUPPL | 2 | Null | 15 |
SUPPL | 4 | Null | 15 |
CDER Filings
RIDGEBACK BIOTHERAPEUTICS
cder:Array
(
[0] => Array
(
[ApplNo] => 761172
[companyName] => RIDGEBACK BIOTHERAPEUTICS
[docInserts] => ["",""]
[products] => [{"drugName":"EBANGA","activeIngredients":"ANSUVIMAB-ZYKL","strength":"400MG\/VIAL","dosageForm":"POWDER;IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761172Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-12-21
)
)