Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | 0.4MG | 0 | VOXZOGO | VOSORITIDE |
002 | INJECTABLE;INJECTION | 0.56MG | 0 | VOXZOGO | VOSORITIDE |
003 | INJECTABLE;INJECTION | 1.2MG | 0 | VOXZOGO | VOSORITIDE |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2021-11-19 | PRIORITY |
Submissions Property Types
CDER Filings
BIOMARIN PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 214938
[companyName] => BIOMARIN PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"VOXZOGO","activeIngredients":"VOSORITIDE","strength":"0.4MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VOXZOGO","activeIngredients":"VOSORITIDE","strength":"0.56MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VOXZOGO","activeIngredients":"VOSORITIDE","strength":"1.2MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"11\/19\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214938s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/19\/2021","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\\\/2021\\\/214938s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214938Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-11-19
)
)