Documents
Application Sponsors
BLA 761148 | SPECTRUM PHARMS | |
Marketing Status
Application Products
001 | INJECTABLE;SUBCUTANEOUS | 13.2MG/0.6ML | 0 | ROLONTIS | EFLAPEGRASTIM-XNST |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2022-09-09 | STANDARD |
Submissions Property Types
CDER Filings
SPECTRUM PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 761148
[companyName] => SPECTRUM PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"ROLONTIS","activeIngredients":"EFLAPEGRASTIM-XNST","strength":"13.2MG\/0.6ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/09\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/761148Orig1s000Corrected_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-09-09
)
)